Moderate to severe atopic dermatitis (AD). MedDRA version: 18.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: Dupilumab
Product Code: SAR231893/REGN668
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dupilumab
CAS Number: 1190264-60-8
Current Sponsor code: Dupilumab
Other descri
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 18 years or older 2. Chronic AD, (according to the American Academy of Dermatology Consensus Criteria),that has been present for at least 3 years before the screening visit. 3. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of outpatient treatment with topical AD medication(s). 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 594 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 106
Exclusion criteria
Exclusion criteria: 1. Prior treatment with dupilumab 2. Important side effects of topical medication (eg, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient's treating physician. 3. At baseline visit >= 30% of the total lesional surface located on areas of thin skin that cannot be safely treated with medium or higher potency TCS (eg, face, neck, intertriginous areas, genital areas, areas of skin atrophy) 4. Recent treatment (within specific time windows before the baseline visit) with systemic corticosteroids, immunosuppressive agents, topical corticosteroids and calcineurin inhibitors, live (attenuated) vaccine, other investigational drugs 5. History of human immunodeficiency virus (HIV) infection 6. HIV or viral hepatitis positive serology at screening 7. Known or suspected immunosuppresion 8. Recent infections requiring antiinfectious treatment 9. Recent history or high risk of clinical endoparasitoses, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization 10. High risk populations (low life expectancy, severe concomitant diseases, etc.) 11. Pregnant or breast-feeding women 12. Patients of reproductive potential and sexually active who are unwilling to use adequate contraceptive methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate the efficacy of dupilumab administered concomitantly with TCS through week 16 in adult patients with moderate-to-severe AD.;Secondary Objective: -Evaluate long-term efficacy of dupilumab when administered concomitantly with TCS for up to 52 weeks. -Evaluate the long-term safety of dupilumab when administered concomitantly with TCS for up to 52 weeks.;Primary end point(s): -Proportion of patients with EASI-75 response (reduction of EASI score by >=75% from baseline) at week 16 -Proportion of patients with both an IGA 0 or 1 (on a 5-point scale) and a reduction from baseline of >=2 points at week 16;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoints: Percent change from baseline to week 16 in weekly average of peak daily Pruritus Numerical Rating Scale (NRS) Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS >=4 from baseline to week 16. Proportion of patients with IGA 0 or 1 and a reduction from baseline of >=2 points at week 52. Proportion of patients with EASI-75 response at week 52. Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS >=3 from baseline to week 16. Percent change from baseline to week 52 in weekly average of peak daily Pruritus NRS. Other Secondary Endpoints: Percent change in EASI score from baseline to week 16. Change from baseline to week 16 in percent BSA. Percent change in SCORing Atopic Dermatitis (SCORAD) from baseline to week 16. Percent change from baseline to week 16 in Global Individual Signs Score (GISS) (erythema, infiltration/papulation, excoriations, lichenification). Change from baseline to week 16 in Dermatology Life Quality Index (DLQI). Change from baseline to week 16 in Hospital Anxiety and Depression Scale (HADS). Change from baseline to week 16 in Patient Oriented Eczema Measure (POEM). Reduction in topical AD medication use through week 16 (determined by the amount of TCS and/or topical calcineurin inhibitors (TCI) used since previous visit in weight). Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS >=3 from baseline to week 52. Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS >=4 from baseline to week 52. Percent change in EASI score from baseline to week 52. Change from baseline to week 52 in percent BSA. Percent Change in SCORAD from baseline to week 52. Percent Change from baseline to week 52 in GISS (erythema, infiltration /papulation, excoriations, lichenification). Change from baseline to week 2 in weekly average of peak daily Prur | — |
Countries
Australia, Belgium, Canada, Croatia, Czech Republic, France, Germany, Guadeloupe, Hungary, Italy, Japan, Korea, Republic of, Latvia, Netherlands, New Zealand, Poland, Romania, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials information
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed