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A Study to Evaluate ABT-494 (Upadacitinib) in Adult Subjects With Moderate to Severe Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02925117
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE October 4, 2016
First Posted Date  ICMJE October 5, 2016
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE October 25, 2016
Actual Primary Completion Date August 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
Mean Percentage Change in EASI score [ Time Frame: At Week 16 ]
Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02925117 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
  • Percent change in EASI score [ Time Frame: From Day 1 (baseline) and Week 8 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.
  • Proportion of participants achieving EASI 75 response [ Time Frame: Up to Week 16 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.
  • Proportion of participants achieving EASI 90 response [ Time Frame: Up to Week 16 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.
  • Proportion of participants achieving SCORAD 90 response [ Time Frame: Up to Week 16 ]
    The SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis (AD).
  • Proportion of participants achieving SCORAD 50 response [ Time Frame: Up to Week 16 ]
    The SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis (AD).
  • Summary of EASI 75 at all visits in Period 2 among those who were re-randomized as EASI 75 non-responders at Week 16 [ Time Frame: Up to Week 88 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.
  • Proportion of participants with Dermatology Life Quality Index (DLQI) = "0" or "1" [ Time Frame: Up to Week 16 ]
    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.
  • Proportion of participants achieving SCORAD 75 response [ Time Frame: Up to Week 16 ]
    The SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis (AD).
  • Percent change in SCORAD score [ Time Frame: From Day 1 to Week 16 ]
    The SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis (AD).
  • Time to loss of EASI 50 response relative to Baseline among those who were re-randomized as EASI 75 responders at Week 16 [ Time Frame: Up to Week 88 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.
  • Change and percent change from Week 16 (re-randomization) in EASI score at all Period 2 visits [ Time Frame: Up to Week 88 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.
  • Proportion of participants achieving EASI 50 response [ Time Frame: Up to Week 16 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.
  • Percent change in pruritus/ itch numerical rating scale (NRS) [ Time Frame: From Day 1 (Baseline) to Week 16 ]
    Itch will be rated from 0 (no itch) to 10 (worst imaginable itch).
  • Proportion of participants achieving an Investigator Global Assessment (IGA) of "0" or "1" [ Time Frame: At Week 16 ]
    The Investigators's Global Assessment (IGA) is a 5-point scale used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 (clear, no inflammatory signs of AD) to 4 (severe, Severe erythema and severe papulation/infiltration with or without oozing/crusting).
  • Change from Baseline in DLQI [ Time Frame: From Day 1 to Week 16 ]
    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.
  • Proportion of Participants achieving an EASI 75 response [ Time Frame: At Week 16 ]
    It is defined as at least a 75% reduction in EASI score relative to the baseline (day 1)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
  • Proportion of Participants achieving an EASI 75 response [ Time Frame: At Week 16 ]
    It is defined as at least a 75% reduction in EASI score relative to the baseline (day 1)
  • Proportion of participants achieving an Investigator Global Assessment (IGA) of "0" or "1" [ Time Frame: At Week 16 ]
    The Investigators's Global Assessment (IGA) is a 5-point scale used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 (clear, no inflammatory signs of AD) to 4 (severe, Severe erythema and severe papulation/infiltration with or without oozing/crusting).
  • Percent change in pruritus/ itch numerical rating scale (NRS) [ Time Frame: From Day 1 (Baseline) to Week 16 ]
    Itch will be rated from 0 (no itch) to 10 (worst imaginable itch).
  • Percent change in EASI score [ Time Frame: From Day 1 (baseline) and Week 8 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.
  • Percent change in SCORAD score [ Time Frame: From Day 1 to Week 16 ]
    The SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis (AD).
  • Proportion of participants achieving EASI 50 response [ Time Frame: Up to Week 16 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.
  • Proportion of participants achieving EASI 75 response [ Time Frame: Up to Week 16 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.
  • Proportion of participants achieving EASI 90 response [ Time Frame: Up to Week 16 ]
    Eczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic eczema.
  • Proportion of participants achieving SCORAD 50 response [ Time Frame: Up to Week 16 ]
    The SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis (AD).
  • Proportion of participants achieving SCORAD 75 response [ Time Frame: Up to Week 16 ]
    The SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis (AD).
  • Proportion of participants achieving SCORAD 90 response [ Time Frame: Up to Week 16 ]
    The SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis (AD).
  • Proportion of participants with Dermatology Life Quality Index (DLQI) = "0" or "1" [ Time Frame: Up to Week 16 ]
    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.
  • Change from Baseline in DLQI [ Time Frame: From Day 1 to Week 16 ]
    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate ABT-494 (Upadacitinib) in Adult Subjects With Moderate to Severe Atopic Dermatitis
Official Title  ICMJE A Phase 2b Multicenter, Randomized, Placebo-Controlled, Double-Blind Dose-Ranging Study to Evaluate ABT-494 (Upadacitinib) in Adult Subjects With Moderate to Severe Atopic Dermatitis
Brief Summary This is an 88-week Phase 2b, randomized, double-blind, parallel-group, placebo-controlled multicenter study to evaluate the safety and efficacy of ABT-494 (upadacitinib) in adult subjects with moderate to severe atopic dermatitis. In Period 1, subjects will be randomized in a 1:1:1:1 ratio to one of four treatment groups.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: ABT-494
    Oral tablet
    Other Name: Upadacitinib
  • Drug: Placebo
    Oral tablet
Study Arms  ICMJE
  • Active Comparator: Participants receiving Dose A
    Participants receiving Dose A once daily (QD) for 16 weeks
    Intervention: Drug: ABT-494
  • Active Comparator: Participants receiving Dose C
    Participants receiving Dose C once daily (QD) for 16 weeks
    Intervention: Drug: ABT-494
  • Placebo Comparator: Participants receiving matching placebo
    Participants receiving matching placebo for 16 weeks
    Intervention: Drug: Placebo
  • Active Comparator: Participants receiving Dose B
    Participants receiving Dose B once daily (QD) for 16 weeks
    Intervention: Drug: ABT-494
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2018)
166
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2016)
160
Actual Study Completion Date  ICMJE January 31, 2019
Actual Primary Completion Date August 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Atopic dermatitis with a diagnosis confirmed by a dermatologist (according to the Hanifin and Rajka criteria) and onset of symptoms at least 1 year prior to baseline.
  • Moderate to severe atopic dermatitis defined by an Eczema Area and Severity Index (EASI)>= 16, Body Surface Area (BSA) >= 10% and an Investigators Global Assessment (IGA) score >= 3 at the Baseline visit.
  • Documented history (within 1 year prior to the screening visit) of inadequate response to treatment with topical corticosteroids (TCS), or topical calcineurin inhibitors (TCI), or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
  • Twice daily use of an additive-free, bland emollient for at least 7 days prior to Baseline.

Exclusion Criteria:

  • Prior exposure to any systemic or topical JAK inhibitor (including but not limited to tofacitinib, baricitinib, ruxolitinib, and filgotinib).
  • Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin within 10 days prior to the Baseline visit.
  • Prior exposure to dupilumab.
  • Prior exposure to any investigational systemic treatment within 30 days or 5 half-lives (whichever is longer) of the Baseline visit or is currently enrolled in another clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Finland,   Germany,   Japan,   Netherlands,   Spain,   United States
Removed Location Countries Ireland
 
Administrative Information
NCT Number  ICMJE NCT02925117
Other Study ID Numbers  ICMJE M16-048
2016-002451-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP