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A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult Patients With Moderate to Severe Hidradenitis Suppurativa
555 patients around the world
Available in Argentina
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.
Novartis Pharmaceuticals
555Patients around the world
This study is for people with
Hidradenitis suppurativa
Requirements for the patient
To 100 Years
All Gender
Medical requirements
- Male and female participants ≥ 18 years of age at the time of signing of the informed consent.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).
- 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.History or current hepatic disease.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.History of hypersensitivity to any of the study drug constituents.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.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.Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.
StudyRECHARGE 1
SponsorNovartis Pharmaceuticals
Study typeInterventional
Conditions
Hidradenitis suppurativa
Requirements
To 100 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06799000
