Terminado antes de tiempoNCT06867094Registro de ClinicalTrials.gov

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis

Colitis Ulcerative

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - 75 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 170 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Por qué se detuvo el estudio

Business decision

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis.

This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment.

Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study).

The study duration will be up to 59 weeks.
The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm.
The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent
Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
Active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician global Assessment (PGA), with a minimum rectal bleeding (RB) subscore ≥1, a minimum stool frequency (SF) subscore ≥1, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent \>15 cm from the anal verge
Must have received prior treatment for UC (either "a" or "b" below or a combination of both "a" and "b"):

1. History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) OR
2. History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (eg. TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or a small molecule (such as a JAKi or S1PRm) for UC
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis
Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the study
Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study
Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools
Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelines
Participants with Positive Hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) and/or hepatitis C virus antibody (HCVAb) at the screening visit
Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
History of gastro-intestinal dysplasia other than completely removed low grade dysplasia OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during endoscopy by the time of the screening visit.
If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for \>10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.
Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drug
Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the screening visit or oral/intramuscular anti-infectives within 14 days prior to the screening visit
Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
Participants who received fecal microbial transplantation within 30 days prior to screening
Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
Participants who received IV corticosteroids within 14 days prior to screening or during screening period
Screening laboratory and other analyses show abnormal results.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento cuádruple

SAR441566 dose regimen 1

Participants will receive SAR441566 dose regimen 1

Drug: SAR441566

SAR441566 dose regimen 2

Participants will receive SAR441566 dose regimen 2

Drug: SAR441566

SAR441566 dose regimen 3

Participants will receive SAR441566 dose regimen 3

Drug: SAR441566

Placebo

Participants will receive SAR441566-matching placebo

Drug: SAR441566 matching Placebo

SAR441566 DRUG

Pharmaceutical form: Tablet Route of administration: Oral

SAR441566 matching Placebo DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)

Plazo: Week 12

Clinical remission by modified Mayo score (mMS) is defined as a mMS ≤2 with no subscore \>1 (stool frequency \[SF\] of 0 or 1 with at least a 1-point decrease from baseline, rectal bleeding \[RB\] of 0 and modified Mayo Endoscopic Subscore \[mMES\] of 0 or 1 where 1 does not include friability).

Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.

Medidas secundarias

Proportion of participants achieving clinical response at Week 12 by modified Mayo Score (mMS)

Plazo: Week 12

Clinical response by modified Mayo score (mMS) is defined as a decrease from baseline in the mMS of ≥2 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1.

Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.

Proportion of participants achieving clinical response at Week 12 by full Mayo score (MS)

Plazo: Week 12

Clinical response by full Mayo score (MS) is defined as a decrease from baseline in the MS of ≥3 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1.

The MS (also referred to as the full Mayo Score) is a composite index designed to measure ulcerative colitis (UC) disease activity and consists of 4 subscores: RB and SF, which are patient-reported subscores, Physician's global assessment (PGA), and endoscopic findings. Individual items are rated 0 to 3, giving the composite score a maximum of 12, with higher scores indicating greater disease severity.

Proportion of participants achieving clinical remission at Week 12 by full Mayo score (MS)

Plazo: Week 12

Clinical remission by full Mayo score (MS) is defined as a MS ≤2 with no score \>1.

Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission at Week 12

Plazo: Week 12

Patient-reported outcome 2 (PRO2) remission is defined as PRO2 score ≤1 with rectal bleeding (RB) of 0, and endoscopic remission is defined as mMES of 0.

PRO2 score is defined as the sum of Mayo SF and RB subscores.

Proportion of participants achieving endoscopic remission at Week 12

Plazo: Week 12

Endoscopic remission is defined as mMES of 0.

Change from baseline in PRO2 from randomization to Week 12

Plazo: From Baseline to Week 12

PRO2 score is defined as the sum of the Mayo SF and RB subscores.

Proportion of participants achieving endoscopic response at Week 12

Plazo: Week 12

Endoscopic response is defined as mMES decrease of at least 1 point.

Proportion of participants achieving endoscopic improvement at Week 12

Plazo: Week 12

Endoscopic improvement is defined as mMES of 0 or 1 where 1 does not include friability.

Proportion of participants achieving HEMI at Week 12

Plazo: Week 12

Histologic endoscopic mucosal improvement (HEMI) is defined by achievement of modified Mayo endoscopic improvement (mMES of 0 or 1 where 1 does not include friability) and histological improvement (original Geboes Score \[OGS\] ≤3.1).

Plasma predose concentrations of SAR441566 at selected visits

Plazo: Up to Week 52

No informado en este registro.

Plasma postdose concentrations of SAR441566 at selected visits

Plazo: Up to Week 52

No informado en este registro.

Number of participants with any treatment-emergent adverse events (TEAEs) during induction and maintenance treatment period

Plazo: Up to Week 52

No informado en este registro.

Number of participants with any treatment-emergent adverse events (TEAEs) during open-label treatment period

Plazo: From Week 12 to Week 52

No informado en este registro.

Proportion achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 12

Plazo: Week 12

Inflammatory Bowel Disease Questionnaire (IBDQ) remission is considered as an IBDQ-32 total score ≥170 points.

IBDQ is designed to capture the patient's experience of IBD on 4 domains of functioning and well-being: bowel and systemic symptoms and emotional and social function. The total IBDQ score ranges from 32 to 224 which indicates better quality of life.

Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 12

Plazo: Week 12

Inflammatory Bowel Disease Questionnaire (IBDQ) response is defined as an increase from baseline in the total IBDQ score in the range of 16 to 32 points.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (117)

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Buscar un centro en este estudio

117 centros

GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003Sun City, Arizona, United StatesEstado desconocido

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (117)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research