A Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (AD)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

422 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-25

Study Completion Date

2016-10-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Subcutaneous injection of Placebo (for Dupilumab) was administered once weekly (QW) from Week 1 (Day 1) to Week 36.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous injection of Placebo (for Dupilumab) was administered once weekly (QW).

Dupilumab 300 mg Q8W

Subcutaneous injection of Dupilumab 300 milligram (mg) alternatively with placebo (matched to Dupilumab) was administered once every eight week (Q8W) from Week 1 to Week 36.

Group Type EXPERIMENTAL

Dupilumab

Intervention Type DRUG

Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered.

Dupilumab 300 mg Q4W

Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered once every four week (Q4W) from Week 1 to Week 36.

Group Type EXPERIMENTAL

Dupilumab

Intervention Type DRUG

Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered.

Dupilumab 300 mg Q2W/QW

Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.

Group Type EXPERIMENTAL

Dupilumab

Intervention Type DRUG

Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered.

Interventions

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Dupilumab

Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered.

Intervention Type DRUG

Placebo

Subcutaneous injection of Placebo (for Dupilumab) was administered once weekly (QW).

Intervention Type DRUG

Other Intervention Names

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REGN668 SAR231893

Eligibility Criteria

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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

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No