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Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03912259
Recruitment Status : Active, not recruiting
First Posted : April 11, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult patients with moderate-to-severe atopic dermatitis (AD).

Secondary Objectives:

  • To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult patients with moderate-to-severe AD.
  • To evaluate the effect of dupilumab on improving patient reported outcomes (PROs).
  • To evaluate dupilumab immunogenicity.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: dupilumab SAR231893 Drug: placebo Drug: Emollient (moisturizer) Phase 3

Detailed Description:
The maximum study duration will be 33 weeks per patient, including a screening period of up to 5 weeks, a 16-week randomized treatment period, and a 12-week follow-up period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Dupilumab
Subcutaneously once every 2 weeks following a loading dose on Day 1
Drug: dupilumab SAR231893
Pharmaceutical form: solution Route of administration: subcutaneous
Other Name: Dupixent

Drug: Emollient (moisturizer)
Pharmaceutical form: cream Route of administration: topical use

Placebo Comparator: Placebo matching dupilumab
Subcutaneously once every 2 weeks (double the amount of placebo on Day 1 to match the loading dose)
Drug: placebo
Pharmaceutical form: solution Route of administration: subcutaneous

Drug: Emollient (moisturizer)
Pharmaceutical form: cream Route of administration: topical use




Primary Outcome Measures :
  1. Investigator's Global Assessment (IGA) [ Time Frame: Baseline to Week 16 ]
    Proportion of patients with both an IGA of 0 to 1 (on a 5-point scale) and IGA reduction from baseline of ≥2 points


Secondary Outcome Measures :
  1. Eczema area and severity index (EASI) -75 response (score reduction ≥75%) [ Time Frame: At Week 16 ]
    Proportion of patients with EASI-75 response (reduction of EASI score by ≥75% from baseline)

  2. Peak score on pruritus numerical rating scale (NRS) (score reduction ≥4) [ Time Frame: Baseline to Week 16 ]
    Proportion of patients with reduction of weekly average of peak daily pruritus NRS ≥4

  3. Peak score on pruritus NRS (score reduction ≥3) [ Time Frame: Baseline to Week 16 ]
    Proportion of patients with reduction of weekly average of peak daily pruritus NRS ≥3

  4. Change in peak score on pruritus NRS [ Time Frame: Baseline to Week 16 ]
    Absolute change in weekly average of peak daily pruritus NRS

  5. Percent change in peak score on pruritus NRS [ Time Frame: Baseline to Week 16 ]
    Percent change in weekly average of peak daily pruritus NRS

  6. Change in EASI score [ Time Frame: Baseline to Week 16 ]
    Percent change in EASI score

  7. Change in BSA affected by atopic dermatitis (AD) [ Time Frame: Baseline to Week 16 ]
    Change in percent BSA of AD involvement

  8. Change in Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline to Week 16 ]
    Absolute change in Dermatology Life Quality Index (DLQI)

  9. Change in Patient Oriented Eczema Measure (POEM) score [ Time Frame: Baseline to Week 16 ]
    Absolute change in Patient Oriented Eczema Measure (POEM)

  10. Change in pruritus NRS score [ Time Frame: Baseline to Week 2 ]
    Percent change in weekly average of peak daily pruritus NRS

  11. Change in EuroQol five dimensions questionnaire (EQ-5D) [ Time Frame: Baseline to Week 16 ]
    Absolute change in EuroQol five dimensions health status questionnaire (EQ-5D)

  12. Percent change in EuroQol five dimensions questionnaire (EQ-5D) [ Time Frame: Baseline to Week 16 ]
    Percent change in EuroQol five dimensions health status questionnaire (EQ-5D)

  13. IGA score reduction ≥2 [ Time Frame: Baseline to Week 16 ]
    Proportion of patients who achieve reduction of IGA score by ≥2

  14. Patients with EASI-50 [ Time Frame: At Week 16 ]
    The proportion of patients with EASI-50 (≥50% improvement from baseline)

  15. Patients with EASI-90 [ Time Frame: At Week 16 ]
    The proportion of patients with EASI-90 (≥90% improvement from baseline)

  16. Patients achieving IGA 0 to 1 and a reduction of ≥2 points [ Time Frame: Baseline to Week 16 ]
    Proportion of patients achieving IGA 0 to 1 and a reduction of ≥2 points

  17. EASI score changes [ Time Frame: Baseline to Week 16 ]
    Absolute changes in EASI score

  18. EASI score changes, percent [ Time Frame: Baseline to Week 16 ]
    Percent changes in EASI score

  19. Change in weekly average of peak daily pruritus NRS score [ Time Frame: Baseline to Week 16 ]
    Absolute changes in weekly average of peak daily pruritus NRS score

  20. Percent change in weekly average of peak daily pruritus NRS score [ Time Frame: Baseline to Week 16 ]
    Percent changes in weekly average of peak daily pruritus NRS score

  21. Patients with "absence of pruritus" or "mild pruritus" in the pruritus categorical scale [ Time Frame: At Week 16 ]
    Proportion of patients who responded "absence of pruritus" or "mild pruritus" in the pruritus categorical scale

  22. Sick leave/missed school days [ Time Frame: Baseline to Week 16 ]
    Number of days with sick leave/missed school days

  23. Sick leave/missed school days, patient proportion [ Time Frame: Baseline to Week 16 ]
    Proportion of patients with sick leave/missed school days

  24. Adverse Events [ Time Frame: Up to Week 28 ]
    Adverse Events based on standard and systematic assessment including clinical laboratory evaluations, vital signs, physical examination and electrocardiogram

  25. Immunogenicity: dupilumab [ Time Frame: Up to Week 28 ]
    Levels of anti-drug antibody against dupilumab



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female, 18 years or older.
  • Chronic AD (according to American Academy of Dermatology Consensus Criteria, 2014) that has been present for at least 3 years before the screening visit.
  • Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits.
  • Investigator's Global Assessment (IGA) score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and baseline visits.
  • Patient with ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits.
  • Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4.
  • Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).

Exclusion criteria:

  • Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:

    • Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-gamma [IFN-γ], Janus kinase inhibitors, azathioprine, methotrexate);
    • Phototherapy for AD.
  • Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit.
  • Treatment with systemic Traditional Chinese Medicine (TCM) within 4 weeks before the baseline visit or treatment with topical TCM within 1 week before the baseline visit.
  • Treatment with biologics as follows:

    • Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer;
    • Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer.
  • Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit).
  • Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit.
  • Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
  • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: patients may be rescreened after infection resolves.
  • Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment.
  • Active tuberculosis (TB), latent untreated tuberculosis or a history of incompletely treated tuberculosis or non-tuberculous mycobacterial infection will be excluded from the study unless it is well documented by a specialist that the patient has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing would be performed according to local guidelines if required by regulatory authorities or ethics committees.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912259


Locations
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China
Investigational Site Number 1560019
Beijing, China, 100034
Investigational Site Number 1560001
Beijing, China, 100044
Investigational Site Number 1560004
Beijing, China, 100050
Investigational Site Number 1560003
Beijing, China, 100191
Investigational Site Number 1560010
Beijing, China, 100730
Investigational Site Number 1560021
Changchun, China, 130021
Investigational Site Number 1560006
Changsha, China, 410011
Investigational Site Number 1560017
Chongqing, China, 400038
Investigational Site Number 1560026
Hangzhou, China, 310006
Investigational Site Number 1560007
Hangzhou, China, 310009
Investigational Site Number 1560013
Jinan, China, 250013
Investigational Site Number 1560020
Kunming, China
Investigational Site Number 1560030
Lianyungang, China, 222002
Investigational Site Number 1560022
Nanjing, China, 210042
Investigational Site Number 1560029
Ningbo, China
Investigational Site Number 1560016
Shanghai, China, 200040
Investigational Site Number 1560023
Shanghai, China, 200092
Investigational Site Number 1560018
Shanghai, China, 200433
Investigational Site Number 1560015
Shanghai, China, 200443
Investigational Site Number 1560002
Shenyang, China, 110001
Investigational Site Number 1560005
Shenyang, China, 110001
Investigational Site Number 1560008
Shenyang, China, 110004
Investigational Site Number 1560024
Shenzhen, China
Investigational Site Number 1560027
Tianjin, China, 300052
Investigational Site Number 1560028
Wuxi, China, 214002
Investigational Site Number 1560012
Xi'An, China, 710004
Investigational Site Number 1560025
Yancheng, China
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03912259     History of Changes
Other Study ID Numbers: EFC15116
U1111-1190-7728 ( Other Identifier: UTN )
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not available for request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Emollients
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents