Clinical trial NCT01639040: Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2012-07-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Male and female patients aged 18 years or older
2. Chronic AD that had been present for at least 2 years

Exclusion Criteria:

1. Prior treatment with Dupilumab
2. Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study
3. AD lesions located on face, flexural, and genital areas
4. Certain treatments and medical procedures, undertaken within a particular time frame prior to the baseline visit, preclude eligibility for participation in the study
5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
6. Treatment with an investigational drug within 8 weeks
7. Known history of human immunodeficiency virus (HIV) infection
8. Presence of certain laboratory abnormalities at the screening visit
9. History of certain opportunistic infections or certain clinical parasite infections
10. History of malignancy within 5 years before the baseline visit, with certain exceptions
11. Pregnant or breast-feeding women
12. Travel within 12 months of study start to areas endemic for parasitic infections, such as developing countries in Africa and the tropical and subtropical regions of Asia
13. History of alcohol or drug abuse within 2 years of the screening visit
14. Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results

Primary outcomes:
measure: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to the end of study (up to Day 78)
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score: Reduction of ≥50 at Day 29 - Censored Last Observation Carried Forward (LOCF)
timeFrame: Day 29
measure: Percent Change in Pruritus Numerical Rating Scale (NRS) From Day 1 (Baseline) to Day 29 (Week 4)
timeFrame: Baseline up to Day 29
measure: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of "0" or "1" at Day 29
timeFrame: Day 29
measure: Percent Change in Investigator's Global Assessment (IGA) Score From Day 1 (Baseline) to Day 29 (Week 4) - Censored LOCF
timeFrame: Baseline up to Day 29
measure: Percent Change in Eczema Area and Severity Index (EASI) Score From Day 1 (Baseline) to Day 29 (Week 4) - Censored LOCF
timeFrame: Baseline up to Day 29
Locations:
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Duelmen
country: Germany
city: Frankfurt
country: Germany
city: Gera
country: Germany
city: Langenau
country: Germany
city: Munster
country: Germany
city: Szeged-Hungary
country: Hungary
city: Szolnok
country: Hungary
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Warszawa
country: Poland
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: Beck LA, Thaci D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suarez-Farinas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.