NCT06840392

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 555 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Remibrutinib Dose A	Remibrutinib Dose A (oral)
DRUG	Remibrutinib Dose B	Remibrutinib Dose B (oral)
DRUG	Placebo 1	Placebo matching to remibrutinib Dose A (oral)
DRUG	Placebo 2	Placebo matching to remibrutinib Dose B (oral)

Timeline

• Start date: 2025-03-20
• Primary completion: 2027-10-29
• Completion: 2028-02-07
• First posted: 2025-02-21
• Last updated: 2026-03-11

Locations

138 sites across 19 countries: United States, Argentina, Austria, Belgium, Canada, Colombia, Czechia, France, Germany, Greece, Hungary, Malaysia, Mexico, Poland, Puerto Rico, Romania, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study