Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)

NCT01979016 | Completed Phase 2 Results

• 1 other identifier: R668-AD-1307
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 4

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).

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16

  The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue medication use were set to missing and missing values imputed by last observation carried forward (LOCF).

  Baseline to Week 16

Secondary Outcomes (13)

• Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16

  Week 16

• Percentage of Participants Who Achieved IGA Score Reduction From Baseline of ≥2 Points at Week 16

  Baseline to Week 16

• Absolute Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16

  Baseline to Week 16

• Percent Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16

  Baseline to Week 16

• Absolute Change From Baseline in EASI Score to Week 16

  Baseline to Week 16

Study Arms (2)

Placebo qw

EXPERIMENTAL

Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15.

Drug: Placebo; Other: Background treatment

Dupilumab 200 mg qw

EXPERIMENTAL

Two subcutaneous injections of Dupilumab 200 milligram (mg) (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.

Drug: Dupilumab; Other: Background treatment

Interventions

Dupilumab DRUG

Also known as: REGN668, SAR231893, Dupixent

Dupilumab 200 mg qw

Placebo DRUG

Matching placebo

Placebo qw

Background treatment OTHER

Participants were required to apply stable doses of a topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit and at least 7 days after the baseline visit (day -7 to day 8).

Also known as: Topical emollient

Dupilumab 200 mg qw; Placebo qw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years or older;
• Chronic AD that had been present for at least 3 years before the screening visit;
• 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;
• Willing and able to comply with all clinic visits and study-related procedures.

You may not qualify if:

• Prior participation in a Dupilumab clinical trial;
• Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;
• 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;
• Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;
• Treatment with certain biologics;
• Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit;
• Planned major surgical procedure during the participant's participation in this study;
• Participant was a member of the investigational team or his/her immediate family;
• Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
• Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study;

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (4)

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Related Publications (2)

• 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.

  PMID: 31252032 DERIVED

• 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.

  PMID: 30194992 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab; Emollients

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Clinical Trial Management
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 8, 2013
• Study Start: December 31, 2013
• Primary Completion: December 31, 2014
• Study Completion: January 31, 2015
• Last Updated: March 18, 2020
• Results First Posted: March 18, 2020

Record last verified: 2020-03

Locations

CA (1); US (3)