A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Proof-of-concept Study Evaluating Efficacy and Safety of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Who Are Inadequate Responders or Intolerant to Topical Corticosteroids
Who is this study for? Adults with moderate-to-severe atopic dermatitis who are inadequate responders or intolerant to topical corticosteroids
What treatments are being studied? Rilzabrutinib
Status: Completed
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This was a parallel treatment, Phase 2, double-blind, 2-arm, placebo-controlled study with 2 staggered cohorts (2 arms in each cohort) to evaluate the efficacy and safety of rilzabrutinib in adult participants (aged at least 18 years) with moderate-to-severe AD and intolerance or inadequate response to topical corticosteroids (TCS). The total study duration per participant was expected to be approximately 21 weeks, including up to 4 weeks of screening, 16 weeks of on-treatment double-blind period, 1 week of post-treatment follow-up.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• AD as defined by the American Academy of Dermatology Consensus Criteria.
• History of AD for at least 12 months prior to baseline as determined by the Investigator through patient interview.
• Eczema Area and Severity Index (EASI) score ≥ 12 at screening and at baseline.
• IGA score ≥ 3 (on the 0 to 4 IGA scale) at baseline.
• BSA of AD involvement ≥ 10% at baseline.
• Documented inadequate response or intolerance to TCS within 6 months prior to baseline visit
• Baseline PP-NRS score for maximum itch intensity ≥4.
• All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• For optional substudy only: Willingness to have 2 tape strips for comparison of baseline and treatment response.
Locations
United States
California
Antelope Valley Clinical Trials Site Number : 8400001
Northridge
Colorado
Asthma and Allergy Associates, PC Site Number : 8400008
Colorado Springs
Florida
Florida International Research Center Site Number : 8400002
Miami
Kentucky
DS Research of Kentucky, LLC Site Number : 8400004
Louisville
Skin Sciences, PLLC Site Number : 8400005
Louisville
Mississippi
Integrative Skin Care of MS/SKYCRNG Site Number : 8400011
Ridgeland
South Carolina
National Allergy and Asthma Research, LLC. Site Number : 8400007
North Charleston
Texas
Orion Clinical Research Site Number : 8400003
Austin
E.P.I.M.R.D dba Western Sky Research, Inc. Site Number : 8400009
El Paso
Other Locations
Canada
Investigational Site Number : 1240013
Greater Sudbury
Investigational Site Number : 1240001
London
Investigational Site Number : 1240002
Markham
Investigational Site Number : 1240004
Québec
Investigational Site Number : 1240008
Red Deer
Investigational Site Number : 1240007
Toronto
Investigational Site Number : 1240011
Toronto
Chile
Investigational Site Number : 1520001
Santiago
Investigational Site Number : 1520002
Santiago
Investigational Site Number : 1520004
Santiago
Germany
Investigational Site Number : 2760001
Bad Bentheim
Investigational Site Number : 2760002
Friedrichshafen
Netherlands
Investigational Site Number : 5280001
Utrecht
Poland
Investigational Site Number : 6160008
Chojnice
Investigational Site Number : 6160005
Gdansk
Investigational Site Number : 6160001
Lodz
Investigational Site Number : 6160002
Lodz
Investigational Site Number : 6160004
Warsaw
Time Frame
Start Date:2021-09-09
Completion Date:2023-06-23
Participants
Target number of participants:124
Treatments
Placebo_comparator: BID cohort: Placebo
Participants received placebo matched to rilzabrutinib orally BID from Day 1 up to Week 16. Consecutive doses were ideally administered 12 hours apart (and not less than 8 hours apart).
Experimental: BID cohort: Rilzabrutinib
Participants received rilzabrutinib 400 milligrams (mg) orally BID from Day 1 up to Week 16. Consecutive doses were ideally administered 12 hours apart (and not less than 8 hours apart).
Placebo_comparator: TID cohort: Placebo
Participants received placebo matched to rilzabrutinib orally TID from Day 1 up to Week 16. Consecutive doses were ideally administered at least 6 hours apart (and not less than 4 hours apart).
Experimental: TID cohort: Rilzabrutinib
Participants received rilzabrutinib 400 mg orally TID from Day 1 up to Week 16. Consecutive doses were ideally administered at least 6 hours apart (and not less than 4 hours apart).