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Bruton's Tyrosine Kinase Inhibitor
Remibrutinib for Hidradenitis Suppurativa (RECHARGE 2 Trial)
Pflugerville, TX
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with moderate to severe HS defined as: A total of at least 5 AN count (abscesses and/or inflammatory nodules) AND Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae)
Be older than 18 years old
Must not have
Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline
Significant bleeding risk or coagulation disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to end of study, assessed up to 72 weeks.
Awards & highlights
Pivotal Trial
Summary
"This trial aims to determine if remibrutinib (LOU064) at two different doses is effective, safe, and well-tolerated compared to a placebo in patients with moderate to severe
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Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones may include reactions at the injection site, headaches, nausea, or potential allergic responses. The safety profile will be closely monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate to severe HS with at least 5 painful bumps in 2 different areas.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have more than 20 fistulas.
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I have a high risk of bleeding or a blood clotting disorder.
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I have had bleeding in my stomach or intestines.
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I haven't had any live vaccines in the last 6 weeks and won't need any during the study.
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I have been treated with remibrutinib or similar medications before.
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I do not have any skin conditions that could affect HS assessment.
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I have a history of liver disease.
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I haven't had major surgery in the last 8 weeks and don't plan any during the study.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to end of study, assessed up to 72 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to end of study, assessed up to 72 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants with Hidradenitis Suppurativa clinical response 50 (HiSCR50) at Week 16
Secondary study objectives
Incidence of treatment emergent adverse events and serious adverse events during the study
Percentage change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16
Proportion of participants experiencing Hidradenitis Suppurativa (HS) flares at Week 16
+5 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Remibrutinib Dose B (Treatment Period 1 and 2)Experimental Treatment1 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 Treatment1 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 Group3 Interventions
Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2
Find a Location
Closest Location:Austin Inst for Clinical Research· Pflugerville, TX· 995 miles
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,956 Previous Clinical Trials
4,272,651 Total Patients Enrolled
12 Trials studying Hidradenitis Suppurativa
3,873 Patients Enrolled for Hidradenitis Suppurativa