Estudio de fase 3, aleatorizado, doble ciego, doble simulacro, controlado con placebo, multicéntrico, para evaluar la eficacia, seguridad y tolerabilidad de 2 dosis de remibrutinib durante un período de tratamiento de 68 semanas en pacientes adultos y adolescentes con hidradenitis supurativa de moderada a grave. (RECHARGE-1)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06799000RENIS: IS004963Tipo: INTERVENTIONALInicio: 31 de ene de 2025Fin estimado: 18 de ene de 2028

Resumen

El propósito de este estudio es establecer la eficacia, seguridad y tolerabilidad de remibrutinib (LOU064) Dosis A y Dosis B en comparación con placebo en participantes con hidradenitis supurativa (HS) de moderada a grave.

Descripción detallada

La duración total del estudio es de 76 semanas y comprende: tamizaje (hasta 4 semanas), Período de tratamiento 1 (16 semanas, tratamiento doble ciego con remibrutinib [Dosis A o Dosis B] o placebo), Período de tratamiento 2 (52 semanas, tratamiento con remibrutinib [Dosis A o Dosis B]) y seguimiento de seguridad (seguimiento sin tratamiento durante 4 semanas). Se alienta a los participantes que interrumpen prematuramente el tratamiento del estudio (ya sea durante el Período de tratamiento 1 o el Período de tratamiento 2) a permanecer en el estudio. Los participantes que no deseen permanecer en el estudio ingresarán a un período de seguimiento de seguridad de 4 semanas.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

Male and female participants ≥ 12 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)

Criterios de exclusión

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. 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.
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.

Intervenciones

drug

Remibrutinib Dose A

Remibrutinib Dose A (oral)

drug

Remibrutinib Dose B

Remibrutinib Dose B (oral)

drug

Placebo 1

Placebo matching to remibrutinib Dose A (oral)

drug

Placebo 2

Placebo matching to remibrutinib Dose B (oral)

Ubicaciones

Novartis Investigative Site

Caba, Buenos Aires, Argentina

RECRUITING

Novartis Investigative Site

CABA, Buenos Aires, Argentina

RECRUITING

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

RECRUITING

Novartis Investigative Site

CABA, Argentina

RECRUITING

Patrocinadores

PrincipalNovartis Pharmaceuticals

Contactos

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com 1-888-669-6682

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com +41613241111

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