Clinical trial NCT01979016: Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy, Safety, Serum Concentration and Biomarker Profile of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis (AD)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2013-11-08
Enrollment: 54
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 of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18 years or older;
2. Chronic AD that had been present for at least 3 years before the screening visit;
3. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable;
4. Willing and able to comply with all clinic visits and study-related procedures.

Exclusion Criteria:

1. Prior participation in a Dupilumab clinical trial;
2. Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;
3. The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment:

   * Systemic corticosteroids;
   * Immunosuppressive/immunomodulating drugs;
   * Phototherapy for AD;
4. Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;
5. Treatment with certain biologics;
6. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit;
7. Planned major surgical procedure during the participant's participation in this study;
8. Participant was a member of the investigational team or his/her immediate family;
9. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
10. Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study;

Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/exclusion criteria are listed.

Primary outcomes:
measure: Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved IGA Score Reduction From Baseline of ≥2 Points at Week 16
timeFrame: Baseline to Week 16
measure: Absolute Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16
timeFrame: Baseline to Week 16
measure: Absolute Change From Baseline in EASI Score to Week 16
timeFrame: Baseline to Week 16
measure: Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score ( EASI-50, EASI-75, and EASI-90 Respectively) at Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16
timeFrame: Baseline to Week 16
measure: Absolute Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) to Week 16
timeFrame: Baseline to Week 16
measure: Changes From Baseline in GISS Cumulative Score to Week 16
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
city: New York
country: United States
state: New York
city: Dallas
country: United States
state: Texas
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: Callewaert C, Nakatsuji T, Knight R, Kosciolek T, Vrbanac A, Kotol P, Ardeleanu M, Hultsch T, Guttman-Yassky E, Bissonnette R, Silverberg JI, Krueger J, Menter A, Graham NMH, Pirozzi G, Hamilton JD, Gallo RL. IL-4Ralpha Blockade by Dupilumab Decreases Staphylococcus aureus Colonization and Increases Microbial Diversity in Atopic Dermatitis. J Invest Dermatol. 2020 Jan;140(1):191-202.e7. doi: 10.1016/j.jid.2019.05.024. Epub 2019 Jun 25.
citation: Guttman-Yassky E, Bissonnette R, Ungar B, Suarez-Farinas M, Ardeleanu M, Esaki H, Suprun M, Estrada Y, Xu H, Peng X, Silverberg JI, Menter A, Krueger JG, Zhang R, Chaudhry U, Swanson B, Graham NMH, Pirozzi G, Yancopoulos GD, D Hamilton JD. Dupilumab progressively improves systemic and cutaneous abnormalities in patients with atopic dermatitis. J Allergy Clin Immunol. 2019 Jan;143(1):155-172. doi: 10.1016/j.jaci.2018.08.022. Epub 2018 Sep 5.