A study to confirm the efficacy and safety of different dupilumab dose regimens in adults with atopic dermatitis (AD)

Phase 1

Active, not recruiting

• Conditions: Atopic dermatitis; MedDRA version: 19.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-003384-38-DE
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-02
• Last Update Posted: 5 December 2016

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

A patient must meet the following criteria to be eligible for inclusion in the study:
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: IGA = 0 or 1 (clear or almost clear) at week 16 OR 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
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 428
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 47

Exclusion Criteria

A patient who meets any of the following criteria will be excluded from the study:
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 patient’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 (eg, 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 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.

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 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.;Secondary Objective: The secondary objective of the study is to assess the safety of different dupilumab dose regimens administered as monotherapy over a period of 36 weeks.;Primary end point(s): • Difference between current study baseline and week 36 in percent<br>change in EASI from the baseline of the initial treatment study (R668-<br>AD-1334 or R668-AD-1416)<br>• Percent of patients maintaining EASI-75 at week 36 in the subset of<br>patients with EASI-75 at baseline.;Timepoint(s) of evaluation of this end point: The primary endpoint will be determined at week 36.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Percent of patients with an increase of =2 points in IGA from baseline<br>to week 36, in the subset of patients with IGA (0,1) at baseline<br>• Percent of patients with IGA(0,1) at week 36 in the subset of patients<br>with IGA(0,1) at baseline<br>• Percent of patients whose peak Pruritus NRS increased by 3 or more<br>points from baseline to week 36 in the subset of patients with peak<br>Pruritus NRS =7 at baseline;Timepoint(s) of evaluation of this end point: The secondary endpoints will be determined from baseline to week 36.