A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa

Key Inclusion Criteria:

1. Male and female participants ≥ 12 years of age at the time of signing of theinformed consent.

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

3. 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)

Key Exclusion Criteria:

1. Presence of more than 20 fistulae/tunnels (both draining and non-draining) in totalat baseline.

2. Any active skin disease or conditions that may interfere with the assessment of HS.

3. Previous exposure to remibrutinib or other BTK inhibitors.

4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30days (for small molecules) prior to randomization, or until the pharmacodynamiceffect has returned to baseline (for biologics), whichever is longer.

5. Significant bleeding risk or coagulation disorders.

6. History of gastrointestinal bleeding.

7. Requirement for anti-platelet (except for acetylsalicylic acid up to 100 mg/d orclopidogrel up to 75 mg/d) or anti-coagulant medication.

8. History or current hepatic disease.

9. Evidence of clinically significant cardiovascular, neurological, psychiatric,pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders,gastrointestinal disease or immunodeficiency that, in the Investigator's opinion,would compromise the safety of the participant, interfere with the interpretation ofthe study results or otherwise preclude participation or protocol adherence of theparticipant.

10. History of hypersensitivity to any of the study drug constituents.

11. Known or suspected infectious disease that is active, chronic or recurrent whichprecludes the participant from participating in the trial as per investigator'sassessment. These infectious diseases include and are not limited to opportunisticinfections (e.g., tuberculosis, atypical mycobacterioses, listeriosis oraspergillosis) and/or known or suspected Human Immunodeficiency Virus (HIV)infection. Should it be required by local regulations and/or considered appropriateby the investigator, an HIV test can be performed to confirm eligibility.

12. History of live attenuated vaccine administration within 6 weeks prior torandomization or requirement to receive these vaccinations at any time while onstudy treatment.

13. Major surgery within 8 weeks prior to screening or planned surgery for the durationof the study.

Other protocol-defined inclusion/exclusion criteria may apply.