Remibrutinib for Hidradenitis Suppurativa

(RECHARGE 2 Trial)

Recruiting at 133 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must not be taking: Antiplatelets, Anticoagulants

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 explores the effectiveness of remibrutinib for individuals with moderate to severe hidradenitis suppurativa (HS), a skin condition causing painful lumps and swelling. Researchers compare two doses of remibrutinib to a placebo (a non-active substance) to determine which is most effective and safe. Individuals who have had HS for at least six months and experience painful lumps in at least two different body areas may be eligible to join. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

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, you may need to adjust your dosage, except for certain low-dose medications like acetylsalicylic acid or clopidogrel.

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

Research shows that remibrutinib is being tested for its safety and effectiveness in treating hidradenitis suppurativa (HS), a skin condition. In earlier studies, many patients tolerated remibrutinib well. Specifically, one study found that 72.7% of patients who took remibrutinib experienced significant improvement in their condition. This suggests that remibrutinib could be a promising option for people with moderate to severe HS. While some individuals might still experience side effects, current evidence supports its potential safety for many users. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Remibrutinib is unique because it targets Bruton's tyrosine kinase (BTK), a key player in inflammatory processes, offering a new approach for treating Hidradenitis Suppurativa. Most current treatments, like antibiotics and biologics, primarily aim to reduce inflammation and control infection, but they don't specifically target the pathways involved in the disease's progression. Researchers are excited about remibrutinib because it directly interferes with the signaling pathways that lead to inflammation and tissue damage, potentially providing more effective and targeted relief for patients. Additionally, remibrutinib's oral administration could offer a more convenient alternative to injectable treatments currently available.

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

Research has shown that remibrutinib, a type of medication, may help treat moderate to severe hidradenitis suppurativa (HS), a skin condition. One study found that about 73% of patients taking a 25 mg dose experienced significant symptom improvement, measured using a specific method for symptom relief. Interestingly, a higher dose proved slightly less effective, with about 48.5% of patients showing improvement. This trial will evaluate different dosing regimens of remibrutinib, including Dose A and Dose B, to further explore its potential as a helpful option for managing HS symptoms. ^{3 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), 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 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.

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 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.

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

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

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/nct06840392

Study to Assess Efficacy Safety and Tolerability of ... 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. 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 ...

9. 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 ... Remibrutinib in patients with moderate to severe hidradenitis suppurativa: Patient reported outcomes from a randomized, phase 2, double-blind, ...