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

• Register: EUCTR
• Last refreshed on: 12 December 2016
• Main ID: EUCTR2014-003384-38-LT
• Date of registration: 29/12/2014
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals, Inc.
• Public title: A study to confirm the efficacy and safety of different dupilumab dose regimens in adults with atopic dermatitis (AD)
• Scientific 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. - Liberty AD Solo - Continue
• Date of first enrolment: 18/02/2015
• Target sample size: 475
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003384-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Canada, Denmark, Estonia, European Union, Finland, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Lithuania, Poland, Singapore, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Clinical Trials information
• Affiliation: Regeneron Pharmaceuticals, Inc.

• Name: Clinical Trials information
• Affiliation: Regeneron Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

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

Birth control exclusion criterion # 5is listed in protocol section 4.2.2


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Atopic dermatitis
MedDRA version: 19.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858

Intervention(s)

Product Name: Dupilumab
Product Code: REGN668/SAR231893
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Dupilumab
CAS Number: 1190264-60-8
Current Sponsor code: REGN668/SAR231893
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: The primary endpoint will be determined at week 36.

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 change in EASI from the baseline of the initial treatment study (R668-
AD-1334 or R668-AD-1416)
• Percent of patients maintaining EASI-75 at week 36 in the subset of patients with EASI-75 at baseline.

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 Outcome(s)

Timepoint(s) of evaluation of this end point: The secondary endpoints will be determined from baseline to week 36.

Secondary end point(s): • Percent of patients with an increase of =2 points in IGA from baseline to week 36, in the subset of patients with IGA (0,1) at baseline
• Percent of patients with IGA(0,1) at week 36 in the subset of patients with IGA(0,1) at baseline
• Percent of patients whose peak Pruritus NRS increased by 3 or more points from baseline to week 36 in the subset of patients with peak
Pruritus NRS =7 at baseline

Secondary ID(s)

IND 107969

R668-AD-1415

Source(s) of Monetary Support

Regeneron Pharmaceuticals, Inc.