Clinical trial NCT01548404: Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study of the Efficacy, Safety, Tolerability, and Pharmacodynamics of Subcutaneously-Administered REGN668 in Adult Patients With Extrinsic 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: 2012-03-08
Enrollment: 109
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 primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

The inclusion criteria included, but were not limited to the following:

1. Male or female, 18 years or older;
2. Chronic Atopic Dermatitis (AD) for at least 3 years;
3. History of inadequate response to a stable (\>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.

Exclusion Criteria:

1. Prior treatment with REGN668;
2. Presence of certain laboratory abnormalities at the screening visit;
3. Treatment with an investigational drug within 8 weeks ;
4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
5. Certain treatments and medical procedures, undertaken within a particular time-frame prior to the baseline visit, preclude eligibility for participation in the study;
6. Known history of human immunodeficiency virus (HIV) infection;
7. History of malignancy within 5 years before the baseline visit, with certain exceptions;
8. Planned surgical procedure during the length of the patient's participation in this study;
9. History of clinical parasite infection;
10. Any medical or psychiatric condition which in the opinion of the investigator or the sponsor's medical monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results;
11. Pregnant or breast-feeding women.

Primary outcomes:
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF)
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 12- LOCF
timeFrame: Week 12
measure: Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI-50) at Week 12- LOCF
timeFrame: Week 12
measure: Change From Baseline in EASI Score at Week 12- LOCF
timeFrame: Baseline to Week 12
measure: Percent Change From Baseline in IGA Score at Week 12- LOCF
timeFrame: Baseline to Week 12
measure: Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 12 - LOCF
timeFrame: Baseline to Week 12
measure: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 12- LOCF
timeFrame: Baseline to Week 12
measure: Change From Baseline in Pruritus Numerical Rating Scale (NRS) to Week 12- LOCF
timeFrame: Baseline to Week 12
measure: Change From Baseline in 5-D Pruritus Scale at Week 12
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Nachod
country: Czechia
city: Svitavy
country: Czechia
city: Usti nad Labem
country: Czechia
city: Nice
country: France
city: Pierre Bénite
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Frankfurt
country: Germany
city: Gera
country: Germany
city: Heidelberg
country: Germany
city: Kiel
country: Germany
city: Münster
country: Germany
city: Kaposvar
country: Hungary
city: Szeged
country: Hungary
city: Szekszard
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.
citation: Tsianakas A, Luger TA, Radin A. Dupilumab treatment improves quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a randomized, placebo-controlled clinical trial. Br J Dermatol. 2018 Feb;178(2):406-414. doi: 10.1111/bjd.15905. Epub 2018 Jan 11.