A Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of 2 Doses of Remibrutinib Over a 68-week Treatment Period in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE-2)
Novartis Pharmaceuticals
Summary
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).
Description
The total duration of the study is 76 weeks and consists of: Screening (up to 4 weeks), Treatment Period 1 (16 weeks, double-blind treatment with remibrutinib (Dose A or Dose B) or placebo, Treatment Period 2 (52 weeks, treatment with remibrutinib (Dose A or Dose B) and Safety Follow-Up (treatment-free follow-up for 4 weeks). Participants who prematurely discontinue study treatment (either during Treatment Period 1 or Treatment Period 2) are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.
Eligibility
- Age range
- 12–100 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Male and female participants ≥ 12 years of age at the time of signing of the informed consent. 2. Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the Baseline visit. 3. Participants with moderate to severe HS defined as: * A total of at least 5 AN count (abscesses and/or inflammatory nodules) AND * Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae) Key Exclusion Criteria: 1. Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total a…
Interventions
- DrugRemibrutinib Dose A
Remibrutinib Dose A (oral)
- DrugRemibrutinib Dose B
Remibrutinib Dose B (oral)
- DrugPlacebo 1
Placebo matching to remibrutinib Dose A (oral)
- DrugPlacebo 2
Placebo matching to remibrutinib Dose B (oral)
Locations (138)
- Total Skin and Beauty Dermatology Center PCBirmingham, Alabama
- CTT ResearchGilbert, Arizona
- Ctr Dermatology and Plastic SurgeryScottsdale, Arizona
- Ctr for Dermatology Clinical ResFremont, California
- USC Keck School of MedicineLos Angeles, California
- MedDerm AssociatesSan Diego, California