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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003384-38-LT

Enrollment

475

Registered

2014-12-29

Start date

2015-02-18

Completion date

Unknown

Last updated

2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

—

Countries

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

Public ContactClinical Trials information

Regeneron Pharmaceuticals, Inc.

clinicaltrial@regeneron.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026