A study to confirm the efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD)
- Conditions
- Atopic dermatitsMedDRA version: 17.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-001198-15-ES
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
A patient must meet the following criteria to be eligible for inclusion in the study:
1. Male or female, 18 years or older
2. Chronic AD, (according to American Academy of Dermatology Consensus Criteria [Eichenfield 2014]), that has been present for at least 3 years before the screening visit
3. EASI score ?16 at the screening and baseline visits
4. 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
5. ?10% body surface area (BSA) of AD involvement at the screening and baseline visits
6. 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
7. Have applied a stable dose of topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit (NOTE: See exclusion criterion #6 for limitations regarding emollients)
Inclusion criteria 8-10 (see protocol section 4.2)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
A patient who meets any of the following criteria will be excluded from the study:
1. Participation in a prior dupilumab clinical study
2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
3.Phototherapy or treatment with immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
4. Treatment with TCS or TCI within 1 week before the baseline visit
5. Treatment with biologics or live attenuated vaccines within protocol-specified timeframes
6. Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.
7. Known or suspected history of immunosuppression
8. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
9. Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit
10. At baseline, presence of any conditions listed as criteria for study drug discontinuation
11. Presence of skin comorbidities that may interfere with study assessments
12. History of malignancy within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
13. Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization
All the exclusion criteria are listed in Protocol section 4.2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to demonstrate the efficacy of dupilumab monotherapy compared to placebo treatment in adult patients with moderate-to-severe AD.;Secondary Objective: The secondary objective of the study is to assess the safety of dupilumab monotherapy compared to placebo treatment in patients with moderate-to-severe AD.;Timepoint(s) of evaluation of this end point: The primary endpoint will be determined at week 16.;Primary end point(s): ? Proportion of patients with both IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of ?2 points at week 16<br>For the European Medicines Agency (EMA) and EMA Reference Market Countries only, the co primary endpoints are:<br>? Proportion of patients with EASI-75 (?75% improvement from baseline) at week 16<br>? Proportion of patients with both IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of ?2 points at week 16
- Secondary Outcome Measures
Name Time Method