A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06840392
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Remibrutinib Dose A — DRUG
    Remibrutinib Dose A (oral)
  • Remibrutinib Dose B — DRUG
    Remibrutinib Dose B (oral)
  • Placebo 1 — DRUG
    Placebo matching to remibrutinib Dose A (oral)
  • Placebo 2 — DRUG
    Placebo matching to remibrutinib Dose B (oral)

Study Details

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).

Key Dates

Start date
Mar 20, 2025
Status verified
Jun 2026
Primary completion
Jun 3, 2027
Completion
Oct 21, 2027

Study Design

Enrollment
565 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Remibrutinib Dose A (Treatment Period 1 and 2)
    articipants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2
  • Experimental: Remibrutinib Dose B (Treatment Period 1 and 2)
    Participants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2
  • Placebo Comparator: Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2)
    Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2

Primary Outcome Measure

Proportion of participants with Hidradenitis Suppurativa clinical response 50 (HiSCR50) at Week 16 [ Time Frame: Week 16 ]

Locations (36)

FacilityCityStateZIPSite coordinators
Total Skin and Beauty Dermatology Center PCBirminghamAlabama35205-
CTT ResearchGilbertArizona85234-
Ctr Dermatology and Plastic SurgeryScottsdaleArizona85260-
Ctr for Dermatology Clinical ResFremontCalifornia95438-
USC Keck School of MedicineLos AngelesCalifornia90033-
MedDerm AssociatesSan DiegoCalifornia92103-
Driven ResearchCoral GablesFlorida33134-
Floridian Research InstituteMiamiFlorida33179-
Sarasota Arthritis Res CtrSarasotaFlorida34239-
University Of South FloridaTampaFlorida33612-
Atlanta Biomedical Clin Res LLCAtlantaGeorgia30331-
Emory School of Med DermatologyAtlantaGeorgia30303-
Northwestern UniversityChicagoIllinois60611-
Endeavor HealthGlenviewIllinois60077-
Dundee DermatologyWest DundeeIllinois60118-
Southern IN Clinical TrialsNew AlbanyIndiana47150-
Beth Israel Deaconess Med CenterBostonMassachusetts02215-
Metro Boston Clinical PartnersBrightonMassachusetts02135-
Clinical Research Inst of MIChesterfieldMichigan48047-
Deluxe DermatologySt LouisMissouri63117-
Skin Specialists PCOmahaNebraska68144-
Vivida DermatologyLas VegasNevada89119-
North Shore University HospitalNew Hyde ParkNew York11040-
Cameron DermatologyNew YorkNew York10023-
Optima Research BoardmanBoardmanOhio44512-
Ohio State UniversityColumbusOhio43210-
Wright State UniversityFairbornOhio45324-
Apex Clinical Research Center LLCMayfield HeightsOhio44124-
Clinical Research Ctr of CarolinasCharlestonSouth Carolina29407-
Goodlettsville Dermatology ResearchGoodlettsvilleTennessee37072-2301-
Accurate Clinical ResearchHumbleTexas77346-
Austin Inst for Clinical ResearchPflugervilleTexas78660-
Center for Clinical Studies-LeeWebsterTexas77598-
Care Access AlexandriaArlingtonVirginia22206-
Complexions DermatologyDanvilleVirginia24541-
Forefront DermatologyViennaVirginia22182-

Find similar trials in Birmingham, AL

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Total Skin and Beauty Dermatology Center PC· Birmingham, ALCTT Research· Gilbert, AZCtr Dermatology and Plastic Surgery· Scottsdale, AZCtr for Dermatology Clinical Res· Fremont, CAUSC Keck School of Medicine· Los Angeles, CAMedDerm Associates· San Diego, CA

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