A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06799000
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
Jan 31, 2025
Status verified
May 2026
Primary completion
May 17, 2027
Completion
Oct 4, 2027

Study Design

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

Arms

  • Experimental: Remibrutinib Dose A (Treatment Period 1 and 2)
    Participants 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
Medical Dermatology SpecialistsPhoenixArizona85006-
Johnson DermatologyFort SmithArkansas72916-
Arkansas Research TrialsNorth Little RockArkansas72117-
Cheryl Effron MD IncAnaheimCalifornia92807-
PhysioseqSacramentoCalifornia95826-
Olive View UCLA Medical CenterSylmarCalifornia91342-
Clinical Trials Research InstituteThousand OaksCalifornia91320-
Howard University College of MedicineWashington D.C.District of Columbia20060-
Florida Academic Centers Research and Education LLCCoral GablesFlorida33134-
University of MiamiHealth SystemMiamiFlorida33125-
Ziaderm Research LLCNorth Miami BeachFlorida33162-
Revival Research Institute LLCEvansGeorgia30809-
Gwinnett Clinical Research CenterSnellvilleGeorgia30078-
Immunology-Rheumatology ResearchSuwaneeGeorgia30024-
Illinois Dermatology InstituteChicagoIllinois60602-
Dawes Fretzin Clinical Rea GroupIndianapolisIndiana46256-
Equity Medical LLCBowling GreenKentucky42104-
Dermat. and Adv. AestheticsLake CharlesLouisiana70605-
Michigan Center for Rsrch CompanyClarkstonMichigan48346-
Henry Ford HospitalDetroitMichigan48202-2689-
Revival Research InstituteTroyMichigan48084-
University of Mississippi Med CtrJacksonMississippi39216-
Care Access HobokenHobokenNew Jersey07030-
Forest Hills Dermatology GroupNew YorkNew York10003-
Icahn School Of Med At Mount SinaiNew YorkNew York10029-
Skinsearch of Rochester IncRochesterNew York14623-
OnSite Clinical Solutions LLCHuntersvilleNorth Carolina28078-
Wake Forest Baptist HealthWinston-SalemNorth Carolina27104-
Unity Clinical ResearchOklahoma CityOklahoma73118-
Essential Medical ResearchTulsaOklahoma74137-
UP Medical Center H SystemPittsburghPennsylvania15213-3403-
Medical University of South Carolina MUSCCharlestonSouth Carolina29425-
Advanced Research ExpertsNashvilleTennessee37211-
Bellaire Dermatology AssociatesBellaireTexas77401-
RFSA DermatologySan AntonioTexas78213-
Virginia Clinical ResearchNorfolkVirginia23507-

Find similar trials in Phoenix, AZ

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Medical Dermatology Specialists· Phoenix, AZJohnson Dermatology· Fort Smith, ARArkansas Research Trials· North Little Rock, ARCheryl Effron MD Inc· Anaheim, CAPhysioseq· Sacramento, CAOlive View UCLA Medical Center· Sylmar, CA

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