A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

Официальное название

A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics With Multiple Therapies in Participants With Active Crohn's Disease or Active Ulcerative Colitis (ASCEND-IBD)

Обзор

This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.

Подробное описание

The purpose of this platform study is to assess the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) to evaluate multiple oral or parenteral experimental therapies for moderately to severely active Crohn's Disease or Ulcerative Colitis.

Вмешательства

• Препарат MT-501
  MT-501
• Препарат MT-201
  MT-201

Первичные конечные точки

• Assess the proportion of participants reporting treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values [Срок оценки: Up to 13 weeks]
• Assess the Proportion of Participants with Endoscopic Response (CD) [Срок оценки: 13 weeks]
• Assess the Proportion of Participants Endoscopic Improvement (UC) [Срок оценки: 12 weeks]
• Assess the Proportion of Participants with Clinical Remission (CD) [Срок оценки: 13 weeks]
• Assess the Proportion of Participants with Clinical Remission (UC) [Срок оценки: 12 weeks]

Вторичные конечные точки (12)

• Assess the Proportion of Participants with Clinical Remission (CD) [Срок оценки: 13 weeks]
• Assess the Proportion of Participants with Clinical Remission (UC) [Срок оценки: 12 weeks]
• Assess the Proportion of Participants with Symptomatic Remission (CD and UC) [Срок оценки: Up to 13 weeks]
• Assess the Proportion of Participants with Clinical Response (CD) [Срок оценки: 13 weeks]
• Assess the Proportion of Participants with Clinical Response (UC) [Срок оценки: 12 weeks]
• Assess the Proportion of Participants with Endoscopic and Clinical Response (CD Only) [Срок оценки: 13 weeks]
• Assess the Proportion of Participants with Histologic Response (UC Only) [Срок оценки: 12 weeks]
• Assess the Proportion of Participants with Histologic Remission (UC only) [Срок оценки: 12 weeks]
• Assess the Proportion of Participants with Histologic-Endoscopic Mucosal Improvement (UC only) [Срок оценки: 12 weeks]
• Characterize the Change in Endoscopy Score (CD) [Срок оценки: 13 weeks]
• Characterize the Change in Endoscopy Score (UC) [Срок оценки: 12 weeks]
• Characterize the Change in Histology Score (CD) [Срок оценки: 13 weeks]

Критерии участия

Inclusion Criteria-Crohn's Disease:

• Diagnosis of Crohn's Disease (CD), as confirmed by endoscopy and histopathology
• Moderately to severely active CD as defined by Clinical Disease Activity Index (CDAI) and Simple Endoscopic Score (SES-CD)
• Meets drug stabilization requirements

Inclusion Criteria-Ulcerative Colitis:

• Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology
• Moderately to severely active UC as defined by a 3-component MMCS
• Meets drug stabilization requirements

Exclusion Criteria-Crohn's Disease:

• Diagnosis of indeterminate colitis
• Suspected or diagnosed intra-abdominal or perianal abscess at Screening
• Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments
• CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement

Exclusion Criteria-Ulcerative Colitis:

• Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation
• Current stoma or impending need for colostomy or ileostomy
• Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase
• Previous total proctocolectomy or subtotal colectomy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 46 центров

• Mirador Therapeutics Selected Site — Birmingham
• Mirador Therapeutics Selected Site — Scottsdale
• Mirador Therapeutics Selected Site — Sun City
• Mirador Therapeutics Selected Site — Little Rock
• Mirador Therapeutics Selected Site — Little Rock
• Mirador Therapeutics Selected Site — Colorado Springs
• Mirador Therapeutics Selected Site — Littleton
• Mirador Therapeutics Selected Site — Miami
• … и ещё 38 центров

Украина · 9 центров

• Mirador Therapeutics Selected Site — Ivano-Frankivsk
• Mirador Therapeutics Selected Site — Kyiv
• Mirador Therapeutics Selected Site — Kyiv
• Mirador Therapeutics Selected Site — Kyiv
• Mirador Therapeutics Selected Site — Kyiv
• Mirador Therapeutics Selected Site — Lutsk
• Mirador Therapeutics Selected Site — Lviv
• Mirador Therapeutics Selected Site — Poltava
• … и ещё 1 центр

Грузия · 8 центров

• Mirador Therapeutics Selected Site — Kutaisi
• Mirador Therapeutics Selected Site — Marneuli
• Mirador Therapeutics Selected Site — Tbilisi
• Mirador Therapeutics Selected Site — Tbilisi
• Mirador Therapeutics Selected Site — Tbilisi
• Mirador Therapeutics Selected Site — Tbilisi
• Mirador Therapeutics Selected Site — Tbilisi
• Mirador Therapeutics Selected Site — Tbilisi

Moldova · 2 центра

• Mirador Therapeutics Selected Site — Chisinau
• Mirador Therapeutics Selected Site — Chisinau

Канада · 1 центр

• Mirador Therapeutics Selected Site — Toronto

Идентификаторы

NCT: NCT07113522 · MT-100-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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