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Bruton's Tyrosine Kinase Inhibitor
Remibrutinib for Hidradenitis Suppurativa (RECHARGE 1 Trial)
Darlinghurst, Australia
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
Key
1. Male and female participants ≥ 18 years of age at the time of signing of the informed consent.
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) 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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for Remibrutinib in this context are not provided, common side effects may include reactions at the injection site, headaches, gastrointestinal issues, and potential allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Key
Select...
I am 18 years or older.
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I have inflammation in at least two different body areas.
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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
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 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:Arkansas Research Trials· North Little Rock, AR· 623 miles
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,960 Previous Clinical Trials
4,274,119 Total Patients Enrolled
12 Trials studying Hidradenitis Suppurativa
3,873 Patients Enrolled for Hidradenitis Suppurativa