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

Launched by NOVARTIS PHARMACEUTICALS · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called remibrutinib for adults with moderate to severe hidradenitis suppurativa (HS), a painful skin condition that causes lumps and sores. The study aims to find out how effective, safe, and tolerable remibrutinib is compared to a placebo, which is a treatment that does not contain any active medicine. The trial is currently recruiting participants aged 18 and older who have been diagnosed with HS for at least six months and have a specific number of abscesses or inflammatory nodules affecting different areas of their body.

To participate, individuals must meet certain criteria, such as having no more than 20 fistulas (abnormal connections between body parts) or other serious health conditions that could interfere with the study. Participants can expect to receive either the study medication or a placebo and will be monitored throughout the trial to assess their health and any changes in their condition. This study is an important step in finding new treatment options for people suffering from hidradenitis suppurativa, and those interested should consult with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Male and female participants ≥ 18 years of age at the time of signing of the informed consent.
• • 2. Diagnosis of HS based on clinical history and physical examination for at least 6 months 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 total at 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 30 days (for small molecules) prior to randomization, or until the pharmacodynamic effect 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 or clopidogrel 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 of the study results or otherwise preclude participation or protocol adherence of the participant.
• • 10. History of hypersensitivity to any of the study drug constituents.
• • 11. Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the trial as per investigator's assessment. These infectious diseases include and are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected Human Immunodeficiency Virus (HIV) infection. Should it be required by local regulations and/or considered appropriate by the investigator, an HIV test can be performed to confirm eligibility.
• • 12. History of live attenuated vaccine administration within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment.
• • 13. Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.
• • Other protocol-defined inclusion/exclusion criteria may apply.