Resumen

El protocolo de este ensayo clínico de fase 2 consiste en un estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, para evaluar la eficacia y seguridad de dupilumab en participantes con colitis ulcerosa (CU) moderada a gravemente activa con fenotipo eosinofílico. Período de cribado: 2 a 4 semanas. Período de tratamiento: Intervención con el producto médico en investigación (PMI) durante 52 semanas (dupilumab o placebo equivalente) desde la semana 0 hasta la semana 52. Brazo abierto (opcional): administración de dupilumab en abierto para los participantes del estudio que cumplan los requisitos. Período de seguimiento: 12 semanas. La duración máxima del estudio por participante es de hasta 68 semanas.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must be ≥18 years of age at the time of signing the informed consent.
Evidence of biomarker enrichment at time of screening.
Moderately to severely active UC, defined as a baseline modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopic subscore assigned during the concurrent local and central reading of the video endoscopy.
Has a screening endoscopy with ≥2 endoscopic subscore in the Mayo score component assessment as determined by concurrent local and central reading of the video endoscopy.
Has a baseline rectal bleeding subscore of ≥1 and baseline a stool frequency score of ≥1 as determined by the Mayo score component assessment.
Participants with inadequate response/non-response, loss of response, or are intolerant of standard biologic therapy for their UC AND/OR Inadequate or non-responders, have shown loss of response, or are intolerant to at least 1 of the following treatments: oral corticosteroids (≤20 mg/day), 5-aminosalicylic acid (ASA) compounds, immunomodulators, small molecules.

Criterios de exclusión

Participants are excluded from the study if any of the following criteria apply:
Severe extensive colitis as evidenced by:
Current hospitalization
Likely to require surgery for the treatment of UC within 12 weeks of Screening Visit
UC limited to the rectum only or to \<20 cm of the colon as determined by central reading.
Presence of an ileal pouch, ostomy, stoma or fistula or history of a fistula.
Require, or required within the 2 months before screening, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from study agent treatment.
Has a prior medical history of eosinophilic colitis.
Participants with abdominal abscess, fulminant disease, or toxic megacolon.
Participants with intestinal failure or short bowel syndrome.
Presence of symptomatic colonic or small bowel obstruction, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy).
History of extensive colonic resection (eg, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity.
History of colonic mucosal dysplasia or presence of adenomatous colonic polyps not removed OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at 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.
Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ubicaciones

Investigational Site Number : 0320006

Mar del Plata, Buenos Aires, Argentina

Investigational Site Number : 0320001

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320004

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320007

Buenos Aires, Argentina

Investigational Site Number : 0320008

Buenos Aires, Argentina

Investigational Site Number : 0320002

Buenos Aires, Argentina

Estudio de fase 2, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, para evaluar la eficacia y seguridad del tratamiento con dupilumab en pacientes con colitis ulcerosa moderada a gravemente activa con fenotipo eosinofílico

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Dupilumab

Placebo

Ubicaciones

Investigational Site Number : 0320006

Investigational Site Number : 0320001

Investigational Site Number : 0320004

Investigational Site Number : 0320007

Investigational Site Number : 0320008

Investigational Site Number : 0320002

Patrocinadores