Remibrutinib for Hidradenitis Suppurativa

(RECHARGE 2 Trial)

Recruiting at 11 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Novartis Pharmaceuticals

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Hepatic disease, Cardiovascular, Neurological, others

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Adults over 18 with moderate to severe hidradenitis suppurativa (HS), a skin condition. Participants must have at least 5 inflamed lesions in two different body areas and have been diagnosed with HS for at least 6 months before the study starts.

Inclusion Criteria

I am 18 years or older.

I have been diagnosed with HS for at least 6 months.

I have moderate to severe HS with at least 5 painful bumps in 2 different areas.

Exclusion Criteria

History of hypersensitivity to any of the study drug constituents

I have more than 20 fistulas.

I have a high risk of bleeding or a blood clotting disorder.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment Period 1

Double-blind treatment with remibrutinib (Dose A or Dose B) or placebo

16 weeks

Treatment Period 2

Treatment with remibrutinib (Dose A or Dose B)

52 weeks

Safety Follow-Up

Treatment-free follow-up for safety monitoring

4 weeks

Treatment Details

Interventions

• Remibrutinib (Bruton's Tyrosine Kinase Inhibitor)

Trial Overview The trial is testing two doses of Remibrutinib, Dose A and Dose B, against placebos to see if they are effective, safe, and tolerable for treating HS. Patients will be randomly assigned to receive either the drug or a placebo.

Participant Groups

Group I: Remibrutinib Dose B (Treatment Period 1 and 2) Experimental Treatment 1 Intervention

Participants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2

Group II: Remibrutinib Dose A (Treatment Period 1 and 2) Experimental Treatment 1 Intervention

articipants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2

Group III: Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2) Placebo Group 3 Interventions

Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD