Remibrutinib for Hidradenitis Suppurativa

(RECHARGE 1 Trial)

Recruiting at 47 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must not be taking: BTK inhibitors, Anti-coagulants

Disqualifiers: Hepatic disease, Cardiovascular, Neurological, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

555 Participants Needed

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) for at least 6 months, having at least 5 abscesses or inflammatory nodules across a minimum of two distinct areas. Individuals not meeting these criteria or with other conditions that could interfere with the trial are excluded.

Inclusion Criteria

I have 5 or more abscesses or inflamed nodules.

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

I have inflammation in at least two different body areas.

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

Trial Overview The study is testing the effectiveness and safety of two different doses of Remibrutinib compared to placebo in treating HS. Participants will be randomly assigned to receive either one of the Remibrutinib doses 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

Participants 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