A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (AD Up)

• ClinicalTrials.gov Identifier: NCT03568318
• Recruitment Status: Active, not recruiting
• First Posted: June 26, 2018
• Results First Posted: March 31, 2022
• Last Update Posted: March 31, 2022
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Study Description

Brief Summary:

The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Placebo; Drug: Upadacitinib; Drug: Topical corticosteroids (TCS)	Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Detailed Description:

This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, and a 30-day follow-up visit. Participants who meet eligibility criteria in the Main Study will be randomly assigned in a 1:1:1 ratio to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, in combination with topical corticosteroids.

Upon completion of enrollment of 810 participants in the Main Study, a supplemental study will continue to enroll adolescent participants (Adolescent Sub-study) until a total of 180 adolescent participants are enrolled in the overall study (Main Study + Adolescent Sub-study).

Randomization for the Main Study will be stratified by Baseline disease severity (validated Investigator Global Assessment Scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other), and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). The separate randomization for the Adolescent Sub-study will be stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]) and by geographic region (US/Puerto Rico/Canada and Other).

At Week 16 of both the Main Study and the Adolescent Sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period, and participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. For the Main Study, the re-randomization will be stratified by Eczema Area and Severity Index (EASI) 50 responder status (Yes/No), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other) and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). For the Adolescent Sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other).

Starting at Week 4, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary The Primary Analysis for the Main Study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the Main Study and the Adolescent Sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 968 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
• Actual Study Start Date: August 9, 2018
• Actual Primary Completion Date: February 16, 2021
• Estimated Study Completion Date: November 16, 2025

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo / Upadacitinib + Topical Corticosteroids; Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.	Drug: Placebo; Tablets taken orally once a day; Drug: Upadacitinib; Tablets taken orally once a day; Other Names: ABT-494; RINVOQ™; Drug: Topical corticosteroids (TCS); Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity. Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Experimental: Upadacitinib 15 mg QD + Topical Corticosteroids; Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.	Drug: Upadacitinib; Tablets taken orally once a day; Other Names: ABT-494; RINVOQ™; Drug: Topical corticosteroids (TCS); Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity. Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Experimental: Upadacitinib 30 mg QD + Topical Corticosteroids; Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.	Drug: Upadacitinib; Tablets taken orally once a day; Other Names: ABT-494; RINVOQ™; Drug: Topical corticosteroids (TCS); Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity. Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.

Outcome Measures

Primary Outcome Measures :

1. Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 [ Time Frame: Baseline and Week 16 ]

   EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

   The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

2. Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 [ Time Frame: Baseline and Week 16 ]

   The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:

   • 0 - Clear: No inflammatory signs of AD;
   • 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
   • 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
   • 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;
   • 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.

Secondary Outcome Measures :

1. Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16 [ Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 16 ]
   Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
2. Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16 [ Time Frame: Baseline and Week 16 ]

   EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

   The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

3. Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4 [ Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 4 ]
   Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
4. Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 4 [ Time Frame: Baseline and Week 4 ]

   EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

   The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

   An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

5. Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2 [ Time Frame: Baseline and Week 2 ]

   EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

   The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

   An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

6. Main Study: Percentage of Participants Achieving an EASI 90 Response at Week 4 [ Time Frame: Baseline and Week 4 ]

   EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

   The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

7. Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16 [ Time Frame: Baseline and Week 16 ]

   EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored from 0 [none], to 3 [severe]) for redness, thickness, scratching, and lichenification.

   The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

   The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a ranked secondary endpoint for participants in the Upadacitinib 30 mg + Topical Corticosteroids group versus Placebo + Topical Corticosteroids group only.

8. Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1 [ Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 1 ]
   Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
9. Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16 [ Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 16 ]
   Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.
10. Main Study: Percent Change From Baseline in EASI Score at Week 16 [ Time Frame: Baseline and Week 16 ]

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).

    The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

11. Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16 [ Time Frame: Baseline and Week 16 ]

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

    The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

    An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

12. Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 [ Time Frame: Baseline and Week 16 ]

    The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:

    • 0 - Clear: No signs of AD;
    • 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
    • 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
    • 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;
    • 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.
13. Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16 [ Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 16 ]
    Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.
14. Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16 [ Time Frame: Baseline and Week 16 ]

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

    The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

    An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.

15. Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4 [ Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 4 ]
    Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.
16. Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 4 [ Time Frame: Baseline and Week 4 ]

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

    The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

    An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

17. Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2 [ Time Frame: Baseline and Week 2 ]

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

    The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

    An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.

18. Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 4 [ Time Frame: Baseline and Week 4 ]

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

    The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

    An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.

19. Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16 [ Time Frame: Baseline and Week 16 ]

    EASI is used to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. and the severity score is calculated as the sum of the intensity scores (scored from 0 [none], to 3 [severe]) for redness, thickness, scratching, and lichenification.

    The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

    An EASI 100 response is defined as a 100% reduction (improvement) from Baseline in EASI score.

    The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a secondary endpoint for participants in the Upadacitinib 30 mg + TCS group versus Placebo + TCS group only.

20. Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1 [ Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 1 ]
    Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.
21. Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16 [ Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 16 ]
    Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.
22. Adolescents: Percent Change From Baseline in EASI Score at Week 16 [ Time Frame: Baseline and Week 16 ]

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).

    The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 75 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age
• Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria.
• Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4.
• Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
• Documented history of inadequate response to topical corticosteroids or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit

Exclusion Criteria:

• Prior exposure to any Janus kinase (JAK) inhibitor
• Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study
• Requirement of prohibited medications during the study
• Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
• Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Contacts and Locations

Locations

United States, Alabama

Total Skin and Beauty Derm Ctr /ID# 200548

Birmingham, Alabama, United States, 35205

Clinical Research Center AL /ID# 201865

Birmingham, Alabama, United States, 35209-6802

ACCEL Research Sites /ID# 213364

Birmingham, Alabama, United States, 35218

Advanced Dermatology and Skin Care Centre /ID# 213550

Mobile, Alabama, United States, 36605-3004

United States, Arizona

Arizona Research Center, Inc. /ID# 200546

Phoenix, Arizona, United States, 85053-4061

Clear Dermatology & Aesthetics Center /ID# 201257

Scottsdale, Arizona, United States, 85255-4134

University of Arizona /ID# 201059

Tucson, Arizona, United States, 85719

United States, California

Bakersfield Derma & Skin Cance /ID# 200892

Bakersfield, California, United States, 93309

Mosaic Dermatology /ID# 200553

Beverly Hills, California, United States, 90211

University of California Irvine /ID# 200902

Irvine, California, United States, 92697-1385

Therapeutics Clinical Research /ID# 200593

San Diego, California, United States, 92123

Stanford University /ID# 200597

Stanford, California, United States, 94305

United States, Colorado

Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822

Aurora, Colorado, United States, 80045-2517

Colorado Center for Dermatology, PLLC /ID# 203626

Centennial, Colorado, United States, 80111-1724

Duplicate_Western States Clinical Research, Inc. /ID# 201702

Wheat Ridge, Colorado, United States, 80033-2896

United States, Connecticut

Dermatology Physicians of Connecticut /ID# 201004

Shelton, Connecticut, United States, 06484-6211

United States, Florida

Clearlyderm Dermatology /ID# 207709

Boca Raton, Florida, United States, 33428

Skin Care Research, LLC /ID# 200812

Boca Raton, Florida, United States, 33486-2269

Clinical Research of West Florida, Inc /ID# 203643

Clearwater, Florida, United States, 33765

Florida Academic Centers Research and Education /ID# 200544

Coral Gables, Florida, United States, 33134

Tory P Sullivan, MD PA /ID# 201174

North Miami Beach, Florida, United States, 33162-4708

Park Avenue Dermatology, PA /ID# 201012

Orange Park, Florida, United States, 32073

Precision Clinical Research /ID# 208734

Sunrise, Florida, United States, 33351-7311

United States, Idaho

Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628

Boise, Idaho, United States, 83713

United States, Illinois

Northwestern University Feinberg School of Medicine /ID# 201646

Chicago, Illinois, United States, 60611-2927

Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556

Skokie, Illinois, United States, 60077

DuPage Medical Group /ID# 202065

Wheaton, Illinois, United States, 60189-3801

United States, Indiana

Deaconess Clinic Downtown /ID# 201001

Evansville, Indiana, United States, 47713-1227

Indiana University /ID# 200515

Indianapolis, Indiana, United States, 46202

United States, Kansas

Epiphany Dermatology of Kansas LLC /ID# 203026

Overland Park, Kansas, United States, 66210

United States, Massachusetts

ORA, Inc. /ID# 202824

Andover, Massachusetts, United States, 01810

Tufts Medical Center /ID# 200570

Boston, Massachusetts, United States, 02111-1552

Beth Israel Deaconess Medical Center /ID# 200545

Boston, Massachusetts, United States, 02215-5400

United States, Michigan

Clin Res Inst of Michigan, LLC /ID# 208020

Chesterfield, Michigan, United States, 48047

Michigan Center for Research Company /ID# 200560

Clarkston, Michigan, United States, 48346

United States, Missouri

MediSearch Clinical Trials /ID# 201006

Saint Joseph, Missouri, United States, 64506

United States, Nebraska

Skin Specialists, PC /ID# 200573

Omaha, Nebraska, United States, 68144

United States, New Hampshire

Dartmouth-Hitchcock Medical Center /ID# 200918

Lebanon, New Hampshire, United States, 03756

United States, New Jersey

Psoriasis Treatment Center of Central New Jersey /ID# 200714

East Windsor, New Jersey, United States, 08520

United States, New York

Juva Skin and Laser Center /ID# 200997

New York, New York, United States, 10022-3204

J. Schwartz, MD, PLLC /ID# 202122

Troy, New York, United States, 12180-2323

United States, Ohio

Bexley Dermatology Research /ID# 200899

Bexley, Ohio, United States, 43209-2422

The Ohio State University /ID# 200542

Columbus, Ohio, United States, 43210-1257

United States, Oklahoma

Vital Prospects Clinical Research Institute, PC /ID# 200901

Tulsa, Oklahoma, United States, 74136-7049

United States, Oregon

Oregon Dermatology and Research Center /ID# 200601

Portland, Oregon, United States, 97210

United States, Pennsylvania

University of Pittsburgh MC /ID# 206057

Pittsburgh, Pennsylvania, United States, 15260

United States, Rhode Island

Rhode Island Hospital /ID# 200566

Providence, Rhode Island, United States, 02903

AAPRI Clinical Research /ID# 221134

Warwick, Rhode Island, United States, 02886-2876

United States, Tennessee

Rivergate Dermatology & Skin Care Center /ID# 201698

Goodlettsville, Tennessee, United States, 37072-2301

Stones River Dermatology /ID# 204962

Murfreesboro, Tennessee, United States, 37129-3194

United States, Texas

Arlington Research Center, Inc /ID# 200559

Arlington, Texas, United States, 76011

Center for Clinical Studies /ID# 200582

Houston, Texas, United States, 77004

Progressive Clinical Research /ID# 201582

San Antonio, Texas, United States, 78229

Center for Clinical Studies - Webster TX /ID# 203186

Webster, Texas, United States, 77598

United States, Utah

Advanced Clinical Research - Woseth Dermatology /ID# 213745

Salt Lake City, Utah, United States, 84117-4209

United States, Virginia

Eastern Virginia Med School /ID# 200994

Norfolk, Virginia, United States, 23507-1627

United States, Washington

Dermatology Associates of Seattle /ID# 200717

Seattle, Washington, United States, 98101

United States, Wisconsin

University of Wisconsin - Madison /ID# 204933

Madison, Wisconsin, United States, 53715-1218

Australia, New South Wales

St George Dermatology & Skin Cancer Centre /ID# 204788

Kogarah, New South Wales, Australia, 2217

Royal North Shore Hospital /ID# 204639

St Leonards, New South Wales, Australia, 2065

Westmead Hospital /ID# 205682

Westmead, New South Wales, Australia, 2145

Australia, Queensland

Veracity Clinical Research /ID# 204793

Woolloongabba, Queensland, Australia, 4102

Australia, Western Australia

Fremantle Dermatology /ID# 205306

Fremantle, Western Australia, Australia, 6160

Austria

Ordensklinikum Linz GmbH Elisabethinen /ID# 209567

Linz, Oberoesterreich, Austria, 4010

Kepler Universitaetsklinikum GmbH /ID# 201075

Linz, Oberoesterreich, Austria, 4021

Medizinische Universitaet Innsbruck /ID# 210897

Innsbruck, Tirol, Austria, 6020

Medizinische Universitaet Wien /ID# 201080

Vienna, Wien, Austria, 1090

Belgium

UZ Brussel /ID# 203557

Jette, Bruxelles-Capitale, Belgium, 1090

UCL Saint-Luc /ID# 202028

Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200

UZ Gent /ID# 202030

Gent, Oost-Vlaanderen, Belgium, 9000

IMTR - Grand Hopital de Charleroi /ID# 202029

Loverval, Belgium, 6280

Canada, Alberta

Kirk Barber Research, CA /ID# 200329

Calgary, Alberta, Canada, T2G 1B1

Dermatology Research Institute Inc. /ID# 200341

Calgary, Alberta, Canada, T2J 7E1

Alberta DermaSurgery Centre /ID# 205674

Edmonton, Alberta, Canada, T6G 1C3

Canada, Newfoundland and Labrador

Karma Clinical Trials /ID# 200339

St. John's, Newfoundland and Labrador, Canada, A1A 4Y3

Canada, Nova Scotia

Eastern Canada Cutaneous Resea /ID# 200335

Halifax, Nova Scotia, Canada, B3H 1Z2

Canada, Ontario

Lynderm Research Inc. /ID# 200338

Markham, Ontario, Canada, L3P 1X2

DermEdge Research Inc. /ID# 200337

Mississauga, Ontario, Canada, L5H 1G9

The Centre for Clinical Trials /ID# 205404

Oakville, Ontario, Canada, L6J 7W5

Angela Montgomery Medicine Professional Corporation /ID# 212653

Ottawa, Ontario, Canada, K1H 7X3

SKIN Centre for Dermatology /ID# 200331

Peterborough, Ontario, Canada, K9J 5K2

The Center For Dermatology /ID# 205409

Richmond Hill, Ontario, Canada, L4B 1A5

Toronto Research Centre /ID# 205411

Toronto, Ontario, Canada, M3H 5Y8

Research Toronto /ID# 205410

Toronto, Ontario, Canada, M4W 2N4

XLR8 Medical Research /ID# 205405

Windsor, Ontario, Canada, N8W 1E6

Canada, Quebec

CHU Sainte-Justine /ID# 206013

Montreal, Quebec, Canada, H3T 1C5

Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403

Québec, Quebec, Canada, G1V 4X7

Dre Angelique Gagne-Henley M.D. inc. /ID# 200330

Saint-Jerome, Quebec, Canada, J7Z 7E2

China, Beijing

Chinese PLA General Hospital /ID# 206786

Beijing, Beijing, China, 100853

China, Guangdong

Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728

Guangzhou, Guangdong, China, 510120

China, Hubei

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669

Wuhan, Hubei, China, 430022

China, Liaoning

The First Hospital of China Medical University /ID# 209840

Shenyang, Liaoning, China, 110001

China, Zhejiang

The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132

Hangzhou, Zhejiang, China, 310006

The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442

Hangzhou, Zhejiang, China, 310009

China

Beijing Friendship Hospital /ID# 207434

Beijing, China, 100032

Xiangya Hospital Central South University /ID# 207510

Changsha, China, 410008

Huashan Hospital of Fudan University /ID# 207437

Shanghai, China, 200040

Czechia

Fakultni nemocnice Plzen /ID# 202044

Plzen, Czechia, 305 99

Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248

Prague, Czechia, 128 08

Sanatorium profesora Arenbergera /ID# 202082

Praha, Czechia, 110 00

Vseobecna fakultni nemocnice v Praze /ID# 202045

Praha, Czechia, 128 08

France

Chu de Nice-Hopital L'Archet Ii /Id# 205780

Nice, Alpes-Maritimes, France, 06200

AP-HM - Hopital de la Timone /ID# 206128

Marseille CEDEX 05, Bouches-du-Rhone, France, 13385

CHRU Tours - Hopital Gatien de Clocheville /ID# 218209

Tours, Centre-Val De Loire, France, 37044

Hopital Saint-Andre /ID# 206129

Bordeaux, France, 33075

Polyclinique Courlancy /ID# 201537

Reims, France, 51100

Germany

Universitaetsklinik Heidelberg /ID# 202097

Heidelberg, Baden-Wuerttemberg, Germany, 69120

Universitaetsklinikum Frankfurt /ID# 202095

Frankfurt am Main, Hessen, Germany, 60590

Universitaetsklinikum Muenster /ID# 202094

Muenster, Nordrhein-Westfalen, Germany, 48149

CMS3 Company for Medical Study /ID# 205195

Selters, Rheinland-Pfalz, Germany, 56242

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256

Kiel, Schleswig-Holstein, Germany, 24105

Universitaetsklinikum Bonn /ID# 202092

Bonn, Germany, 53127

TFS Trial Form Support GmbH /ID# 202096

Hamburg, Germany, 20537

Medizinische Hochschule Hannover /ID# 202098

Hannover, Germany, 30625

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194

Mainz, Germany, 55131

Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093

Munich, Germany, 81675

Greece

401 GSNA - 401 Army General Hospital /ID# 211963

Athens, Attiki, Greece, 11525

Children's Hosp P. A. Kyriakou /ID# 217573

Athens, Attiki, Greece, 11527

University General Hospital Attikon /ID# 201126

Athens, Attiki, Greece, 12462

General Hospital Andreas Syggros /ID# 201123

Athens, Attiki, Greece, 16121

Papageorgiou General Hospital Thessaloniki /ID# 202392

Stavroupoli (Thessalonikis), Thessaloniki, Greece, 55536

Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124

Thessaloniki, Greece, 54643

Hong Kong

Prince of Wales Hospital /ID# 205152

Hong Kong, Hong Kong, 999077

Queen Mary Hospital /ID# 205146

Hong Kong, Hong Kong, 999077

Hungary

Oroshazi Korhaz /ID# 203525

Oroshaza, Bekes, Hungary, 5900

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144

Szeged, Csongrad, Hungary, 6725

Debreceni Egyetem Klinikai Kozpont /ID# 201765

Debrecen, Hajdu-Bihar, Hungary, 4032

Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866

Debrecen, Hungary, 4031

Allergo-Derm Bakos Kft. /ID# 205361

Szolnok, Hungary, 5000

Ireland

St James Hospital /ID# 201118

Dublin 8, Dublin, Ireland, D08 NHY1

South Infirmary Victoria University Hospital /ID# 201079

Cork, Ireland, T12 X23H

University Hospital Waterford /ID# 201253

Waterford, Ireland, X91 ER8E

Israel

Soroka University Medical Center /ID# 206652

Be'er Sheva, HaDarom, Israel, 8443901

The Chaim Sheba Medical Center /ID# 201611

Ramat Gan, Tel-Aviv, Israel, 5265601

Tel Aviv Sourasky Medical Center /ID# 201608

Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906

HaEmek Medical Center /ID# 201958

Afula, Israel, 1834111

Rabin Medical Center /ID# 201959

Petakh Tikva, Israel, 4941492

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014

Rome, Lazio, Italy, 00168

Istituto Clinico Humanitas /ID# 200739

Rozzano, Milano, Italy, 20089

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690

Ancona, Italy, 60126

A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742

Catania, Italy, 95123

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744

Milan, Italy, 20122

Azienda Ospedaliera Universitaria Federico II /ID# 200751

Napoli, Italy, 80131

Japan

Chukyo Hospital /ID# 202311

Nagoya-shi, Aichi, Japan, 457-8510

Medical Corporation Matsuo Clinic /ID# 202312

Fukuoka-shi, Fukuoka, Japan, 819-0373

Hiroshima University Hospital /ID# 201914

Hiroshima-shi, Hiroshima, Japan, 734-8551

Hiramoto skin clinic /ID# 204048

Amagasaki-shi, Hyogo, Japan, 661-0953

National Hospital Organization Sagamihara National Hospital /ID# 201658

Sagamihara-shi, Kanagawa, Japan, 252-0392

Queens Square Medical Center dermatology allergology /ID# 203850

Yokohama-shi, Kanagawa, Japan, 220-6208

Kyoto University Hospital /ID# 201654

Kyoto-shi, Kyoto, Japan, 606-8507

Tohoku University Hospital /ID# 206322

Sendai-shi, Miyagi, Japan, 9808574

Osaka Habikino Medical Center /ID# 204243

Habikino-shi, Osaka, Japan, 583-8588

Jichi Medical University Hospital /ID# 201913

Shimotsuke-shi, Tochigi, Japan, 329-0498

Juntendo University Hospital /ID# 202888

Bunkyo-ku, Tokyo, Japan, 113-8431

Tokai University Hachioji Hospital /ID# 201711

Hachioji-shi, Tokyo, Japan, 192-0032

Maruyama Dermatology Clinic /ID# 202350

Koto-ku, Tokyo, Japan, 136-0074

Yamate Dermatological Clinic /ID# 202130

Shinjuku-ku, Tokyo, Japan, 1690075

Netherlands

Erasmus Medisch Centrum /ID# 202196

Rotterdam, Zuid-Holland, Netherlands, 3015 GD

Academisch Medisch Centrum /ID# 202193

Amsterdam, Netherlands, 1105 AZ

Universitair Medisch Centrum Groningen /ID# 202195

Groningen, Netherlands, 9713 GZ

Universitair Medisch Centrum Utrecht /ID# 202194

Utrecht, Netherlands, 3584 CX

New Zealand

Clinical Trials NZ /ID# 205336

Hamilton, New Zealand, 3204

Norway

Haukeland University Hospital /ID# 201152

Bergen, Hordaland, Norway, 5021

Universitetssykehuset N-Norge, Harstad /ID# 201269

Harstad, Troms, Norway, 9406

Universitetssykehuset N-Norge, Tromso /ID# 201270

Tromso, Troms, Norway, 9019

Rikshospitalet OUS HF /ID# 201271

Oslo, Norway, 0450

Puerto Rico

Dr. Samuel Sanchez PSC /ID# 202002

Caguas, Puerto Rico, 00727

Clinical Research Puerto Rico /ID# 203644

San Juan, Puerto Rico, 00909

GCM Medical Group PSC - Hato Rey /ID# 202003

San Juan, Puerto Rico, 00917-3104

Slovakia

Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372

Banska Bystrica, Slovakia, 975 17

Univerzitna nemocnica Martin /ID# 203851

Martin, Slovakia, 036 01

Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240

Nove Zamky, Slovakia, 940 34

Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373

Presov, Slovakia, 081 01

Spain

Hospital Universitario de Puerto Real /ID# 200875

Puerto Real, Cadiz, Spain, 11510

Hospital General Universitario Alicante /ID# 200873

Alicante, Spain, 03010

Hospital Santa Creu i Sant Pau /ID# 201325

Barcelona, Spain, 08041

Hospital Universitario de la Princesa /ID# 201517

Madrid, Spain, 28006

Hospital Universitario 12 de Octubre /ID# 201135

Madrid, Spain, 28041

Hospital Universitario La Paz /ID# 205438

Madrid, Spain, 28046

Sweden

Skane University Hospital Lund /ID# 201244

Lund, Skane Lan, Sweden, SE 221 41

Sahlgrenska University Hospital /ID# 201274

Gothenburg, Vastra Gotalands Lan, Sweden, 413 46

Sodersjukhuset /ID# 201242

Stockholm, Sweden, 118 83

Karolinska University Hospital /ID# 201243

Stockholm, Sweden, 171 76

United Kingdom

Barts Health NHS Trust /ID# 201044

London, London, City Of, United Kingdom, E1 2ES

Guy's and St Thomas' NHS Foundation Trust /ID# 201193

London, London, City Of, United Kingdom, SE1 9RT

Guy's and St Thomas' NHS Foundation Trust /ID# 204642

London, London, City Of, United Kingdom, SE1 9RT

Oxford University Hospitals NHS Foundation Trust /ID# 202052

Oxford, Oxfordshire, United Kingdom, OX3 9DU

NHS Tayside /ID# 202081

Dundee, Scotland, United Kingdom, DD2 1UB

NHS Greater Glasgow and Clyde /ID# 201374

Glasgow, Scotland, United Kingdom, G12 0XH

Leeds Teaching Hospitals NHS Trust /ID# 201106

Leeds, United Kingdom, LS9 7TF

Sponsors and Collaborators

AbbVie

Investigators

• Study Director: ABBVIE INC.; AbbVie

  Study Documents (Full-Text)

Documents provided by AbbVie:

Study Protocol  [PDF] April 29, 2020

Statistical Analysis Plan  [PDF] June 3, 2020

More Information

Additional Information:

This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Silverberg JI, Simpson EL, Calimlim BM, Litcher-Kelly L, Li X, Sun X, Leshem YA. Determining Severity Strata for Three Atopic Dermatitis Patient-Reported Outcome Questionnaires: Defining Severity Score Ranges for the Worst Pruritus Numerical Rating Scale and the Atopic Dermatitis Symptom and Impact Scales (ADerm-SS and ADerm-IS). Dermatol Ther (Heidelb). 2022 Dec;12(12):2817-2827. doi: 10.1007/s13555-022-00836-5. Epub 2022 Nov 4.

Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.

Reich K, Teixeira HD, de Bruin-Weller M, Bieber T, Soong W, Kabashima K, Werfel T, Zeng J, Huang X, Hu X, Hendrickson BA, Ladizinski B, Chu AD, Silverberg JI. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 5;397(10290):2169-2181. doi: 10.1016/S0140-6736(21)00589-4. Epub 2021 May 21. Erratum In: Lancet. 2021 Jun 19;397(10292):2336. Lancet. 2021 Aug 28;398(10302):746.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT03568318
• Other Study ID Numbers: M16-047; 2017-005126-37 ( EudraCT Number )
• First Posted: June 26, 2018
• Results First Posted: March 31, 2022
• Last Update Posted: March 31, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:

Atopic Dermatitis; Upadacitinib

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Upadacitinib; Janus Kinase Inhibitors; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents