NCT01639040

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Safety of REGN668 Administered Concomitantly With Topical Corticosteroids to Patients With Moderate-to-Severe Atopic Dermatitis

Completed Phase 2 Results posted Last updated 22 May 2017

What this trial tests

Phase 2 trial testing Dupilumab in Atopic Dermatitis in 31 participants. Completed in 1 December 2012.

Timeline

1 July 2012

Primary endpoint
1 December 2012

1 December 2012

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	31
Start date	1 July 2012
Primary completion	1 December 2012
Estimated completion	1 December 2012
Sites	13 locations across Germany, Hungary, Poland

Drugs / interventions tested

• Dupilumab (DUPILUMAB) — full drug profile →
• Placebo (for Dupilumab) — full drug profile →
• Topical Corticosteroid (TCS) — full drug profile →

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
  Time frame: Baseline up to the end of study (up to Day 78)
  Any untoward medical occurrence in a subject who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (from start of administration of first dose of study drug to the end of s

Sponsor's own description

The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis.
   Beck LA, Thaçi D, Hamilton JD, Graham NM, et al · · 2014 · cited 1014× · PMID 25006719 · DOI 10.1056/nejmoa1314768
2. Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis.
   Beck LA, Thaçi D, Deleuran M, Blauvelt A, et al · · 2020 · cited 94× · PMID 32557382 · DOI 10.1007/s40257-020-00527-x
3. Exploratory Population PK Analysis of Dupilumab, a Fully Human Monoclonal Antibody Against IL-4Rα, in Atopic Dermatitis Patients and Normal Volunteers.
   Kovalenko P, DiCioccio AT, Davis JD, Li M, et al · · 2016 · cited 59× · PMID 27778477 · DOI 10.1002/psp4.12136
4. Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults.
   Xu X, Zheng Y, Zhang X, He Y, et al · · 2017 · cited 10× · PMID 29312544 · DOI 10.18632/oncotarget.22499
5. The 12th World Congress on Inflammation : 8-12 August, 2015 Seaport Hotel and World Trade Center, Boston, USA.
   · 2015 · cited 3× · PMID 26208821 · DOI 10.1007/s00011-015-0839-4