Acne Inversa Clinical Study (18-100 yrs) |Phoenix, AZ

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of 2 Doses of Remibrutinib Over a 68-week Treatment Period in Adult Patients With Moderate to Severe Hidradenitis Suppurativa

Study Description

The total duration of the study is 76 weeks and consists of: Screening (up to 4 weeks), Treatment Period 1 (16 weeks, double-blind treatment with remibrutinib (Dose A or Dose B) or placebo, Treatment Period 2 (52 weeks, treatment with remibrutinib (Dose A or Dose B) and Safety Follow-Up (treatment-free follow-up for 4 weeks).
Participants who prematurely discontinue study treatment (either during Treatment Period 1 or Treatment Period 2) are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.

Brief Summary

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).

Condition or Disease

Hidradenitis Suppruativa

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	555
Primary Outcome Measures	1. Proportion of participants with Hidradenitis Suppurativa clinical response 50 (HiSCR50) at Week 16
Actual Study Start Date:	January 2025
Estimated Primary Completion Date:	September 2028

Eligibility Criteria

Ages Eligible for Study:	18 to 100 years old
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Hidradenitis Supurativa

Inclusion Criteria

Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the Baseline visit
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)

Exclusion Criteria

Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline
Any active skin disease or conditions that may interfere with the assessment of HS
Previous exposure to remibrutinib or other BTK inhibitors
Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) prior to randomization, or until the pharmacodynamic effect has returned to baseline (for biologics), whichever is longer
Significant bleeding risk or coagulation disorders
History of gastrointestinal bleeding
Requirement for anti-platelet (except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d) or anti-coagulant medication.

ADDITIONAL DETAILS

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Moderate-to-Severe Hidradenitis Suppruativa Study (18-100 Years)