Remibrutinib for Hidradenitis Suppurativa

(RECHARGE 1 Trial)

Recruiting at 155 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called remibrutinib to evaluate its effectiveness and safety for individuals with moderate to severe hidradenitis suppurativa (HS), a skin condition that causes painful lumps under the skin. Participants will take either one of two doses of remibrutinib or a placebo (a pill with no active medicine) to compare results. Individuals who have had HS for at least six months, with at least five lumps affecting two different body areas, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially bringing a new treatment to market.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anti-platelet or anti-coagulant medications, there are specific restrictions, and you should discuss your medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that remibrutinib is generally well-tolerated by patients with conditions like hidradenitis suppurativa. In a recent study, 72.7% of patients taking remibrutinib experienced positive results without major safety issues. Over two years, the treatment proved safe for patients with moderate to severe cases. Although some side effects may occur, the data supports its safety for most people. Further testing of this drug aims to confirm these findings, and joining the trial could provide more insights into its safety for treating hidradenitis suppurativa. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for hidradenitis suppurativa?

Remibrutinib is unique because it targets Bruton's tyrosine kinase (BTK), which is a new approach for treating hidradenitis suppurativa. Unlike standard treatments like antibiotics, hormonal therapies, or biologics such as adalimumab that focus on reducing inflammation or altering the immune response, remibrutinib directly inhibits BTK, a key player in the body's inflammatory processes. This targeted action has the potential to provide more effective and rapid relief from symptoms by addressing the underlying mechanisms of the condition, which is why researchers are excited about its potential.

What evidence suggests that remibrutinib might be an effective treatment for hidradenitis suppurativa?

Research has shown that remibrutinib may help treat moderate to severe hidradenitis suppurativa (HS). In earlier studies, about 73% of patients who took a 25 mg dose twice a day experienced significant skin improvement. This trial will randomize participants to receive either remibrutinib Dose A, Dose B, or a placebo followed by remibrutinib Dose B. Overall, remibrutinib has been well-tolerated and has shown a positive effect on HS symptoms in these studies. ^{4 6 7 8 9}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11527436/

Hidradenitis suppurativa: key insights into treatment success ... Efficacy and safety of the oral Bruton's tyrosine kinase inhibitor, remibrutinib, in patients with moderate to severe hidradenitis suppurativa ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06799000?cond=Hidradenitis%20Suppurativa&viewType=Table&rank=7

A Phase 3 Study to Assess Efficacy Safety and Tolerability ... 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 ...

3. novartis.com novartis.com/news/media-releases/novartis-data-presentations-aaaai-and-aad-underscore-commitment-advancing-treatment-hidradenitis-suppurativa-hs-and-chronic-spontaneous-urticaria-csu

Novartis data presentations at AAAAI and AAD underscore ... Remibrutinib in patients with moderate to severe hidradenitis suppurativa: Patient reported outcomes from a randomized, phase 2, double ...

4. biospace.com biospace.com/novartis-remibrutinib-shows-promise-in-small-mid-stage-hidradenitis-suppurativa-study

Novartis' Remibrutinib Shows Promise in Small Mid-Stage ... At 16 weeks, around 73% of patients treated with the 25-mg dose responded to remibrutinib, while the higher dose level was slightly less ...

5. epocrates.com epocrates.com/online/article/aad-2024-remibrutinib-well-tolerated-for-moderate-to-severe-hidradenitis

AAD 2024: Remibrutinib well-tolerated for moderate-to- ... 72.7% patients treated with remibrutinib 25 mg twice-daily achieved the sHiSCR endpoint, compared with 48.5% of those in the 100 mg cohort and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06840392

NCT06840392 | Study to Assess Efficacy Safety and ... 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 ...

7. novartis.com novartis.com/clinicaltrials/study/nct06799000

A Phase 3 Study to Assess Efficacy Safety and Tolerability ... 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 ...

8. prnewswire.com prnewswire.com/news-releases/novartis-data-presentations-at-aaaai-and-aad-underscore-commitment-to-advancing-treatment-of-hidradenitis-suppurativa-hs-and-chronic-spontaneous-urticaria-csu-302388019.html

Novartis data presentations at AAAAI and AAD underscore ... Two-year efficacy and safety data analyses from Phase III ... Remibrutinib in patients with moderate to severe hidradenitis suppurativa ...

9. mountsinai.org mountsinai.org/clinical-trials/phase-3-study-to-assess-efficacy-safety-tolerability-of-remibrutinib-in-adult-patients-with-moderate-to-severe-hidradenitis-suppurativa

A Phase 3 Study to Assess Efficacy Safety and Tolerability ... 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 ...