Clinical trial NCT02395133: A Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (AD)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Multiple Dupilumab Dose Regimens Administered as Monotherapy for Maintaining Treatment Response in Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Eczema
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2015-03-20
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study was to assess the ability of different Dupilumab dose regimens, administered as monotherapy, to maintain the treatment response achieved after 16 weeks of initial treatment with Dupilumab monotherapy compared to placebo.


Eligibility criteria: Key Inclusion Criteria:

1. Must have completed the treatment phase in 1 of the two 16-week initial treatment studies (R668-AD-1334 or R668-AD-1416).
2. Must have achieved at least 1 of the following 2 treatment success criteria:

   Investigator Global Assessment (IGA) = 0 or 1 (clear or almost clear) at week 16 OR Eczema Area and Severity Index \>= 75% (EASI-75) (at least 75% reduction in EASI score from baseline to week 16)
3. Must be willing and able to comply with clinic visits and study-related procedures
4. Must provide signed informed consent
5. Must be able to understand and complete study-related questionnaires

Key Exclusion Criteria:

1. Receipt of rescue medication for AD in the initial treatment study
2. Any conditions that require permanent discontinuation of study treatment in either initial treatment study
3. Planned or anticipated major surgical procedure during the participants's participation in this study
4. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during this study
5. Women unwilling to use adequate birth control, if of reproductive potential\* and sexually active. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception, whenever engaging in heterosexual intercourse, throughout the duration of the study and for 120 days after last dose of study drug. These include hormonal contraceptives, intrauterine device, or double barrier contraception (e.g, condom + diaphragm), or a male partner with documented vasectomy. Additional requirements for acceptable contraception may apply in certain countries, based on local regulations. Investigators in these countries will be notified accordingly in a protocol clarification letter.

(\*For females, menopause is defined as at least 12 consecutive months without menses; if in question, a follicle stimulating hormone level of \>= 25 milli units per milliliter (mU/mL) must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions are not required to use additional contraception).

Primary outcomes:
measure: Difference Between Current Study Baseline and Week 36 in Percent Change in EASI From Parent Study Baseline (NCT02277743 and NCT02277769)
timeFrame: Baseline (Parent Study), Baseline (Current Study) and Week 36 (Current study)
measure: Percentage of Participants With Eczema Area and Severity Index >= 75% [EASI-75] at Baseline of Current Study Maintaining EASI-75 at Week 36
timeFrame: Week 36
Secondary outcomes:
measure: Percentage of Participants Maintaining Investigator Global Assessment (IGA) Response Within 1 Point of Baseline at Week 36
timeFrame: Baseline, Week 36
measure: Percentage of Participants Maintaining Investigator Global Assessment (IGA) Response at 0 or 1 Point at Week 36
timeFrame: Week 36
measure: Percentage of Participants With Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score Increased by 3 or More Points From Baseline to Week 35
timeFrame: Baseline up to Week 35
measure: Time to First Event of Investigator's Global Assessment (IGA) >= 2 for Participants With IGA 0 or 1 at Baseline
timeFrame: Baseline up to Week 36
measure: Percentage of Participants With Increased Investigator's Global Assessment (IGA) Score 3 or 4 at Week 36
timeFrame: Week 36
measure: Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (>= 50% Reduction in EASI Score) at Week 36
timeFrame: Week 36
measure: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 36
timeFrame: Baseline, Week 36
measure: Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 36
timeFrame: Baseline, Week 36
measure: Absolute Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score at Week 35
timeFrame: Baseline, Week 35
measure: Absolute Change From Baseline in Body Surface Area (BSA) Through Week 36
timeFrame: Baseline through Week 36
measure: Absolute Change From Baseline Through in Patient Oriented Eczema Measure (POEM) Through Week 36
timeFrame: Baseline through Week 36
measure: Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 36
timeFrame: Baseline through Week 36
measure: Absolute Change From Baseline in Hospital Anxiety Depression Scale (HADS) Through Week 36
timeFrame: Baseline through Week 36
measure: Difference Between Current Study Baseline and Week 36 in Percent Change in SCORAD From Parent Study Baseline
timeFrame: Baseline (Parent Study), Baseline (Current Study) and Week 36 (Current study)
measure: Difference Between Current Study Baseline and Week 35 in Percent Change in Peak Weekly Pruritus NRS From Parent Study Baseline
timeFrame: Baseline (Parent Study), Baseline (Current Study) and Week 35 (Current study)
measure: Annualized Event Rate of Skin Infection Treatment- Emergent Adverse Events (TEAEs)
timeFrame: Baseline through Week 36
measure: Annualized Event Rate of Flares
timeFrame: Baseline through week 36
measure: Percentage of Well-Controlled Weeks During the On-treatment Period
timeFrame: Baseline through Week 36
Other outcomes:
Locations:
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: Worm M, Simpson EL, Thaci D, Bissonnette R, Lacour JP, Beissert S, Kawashima M, Ferrandiz C, Smith CH, Beck LA, Chan KC, Chen Z, Akinlade B, Hultsch T, Staudinger H, Gadkari A, Eckert L, Davis JD, Rajadhyaksha M, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Ardeleanu M. Efficacy and Safety of Multiple Dupilumab Dose Regimens After Initial Successful Treatment in Patients With Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020 Feb 1;156(2):131-143. doi: 10.1001/jamadermatol.2019.3617.