A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

A Phase 2, Multicenter, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics with Multiple Therapies in Participants With Active Crohns Disease or Active Ulcerative Colitis - ASCEND-IBD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099316

Enrollment

210

Registered

2025-12-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K519- Ulcerative colitis, unspecified Health Condition 2: K509- Crohns disease, unspecified

Interventions

Intervention1: MT-501: MT-501 tablets will be administered daily for up to 13 weeks Control Intervention1: Placebo: Placebo tablets will be administered daily for up to 13 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria Crohns Disease a. Diagnosis of Crohn s Disease as confirmed by endoscopy and histopathology b. Moderately to severely active CD as defined by Clinical Disease Activity Index and Simple Endoscopic Score c. Meets drug stabilization requirements Inclusion Criteria Ulcerative Colitis a. Diagnosis of Ulcerative Colitis as confirmed by endoscopy and histopathology b. Moderately to severely active UC as defined by a 3 component MMCS c Meets drug stabilization requirements

Exclusion criteria

Exclusion criteria: Exclusion Criteria Crohns Disease a. Diagnosis of indeterminate colitis b. Suspected or diagnosed intra-abdominal or perianal abscess at Screening c. Previous small bowel resection with combined resected length of greater than 100 cm or previous colonic resection of greater than 2 segments d. CD isolated to the stomach duodenum jejunum or perianal region without colonic and or ileal involvement Exclusion Criteria Ulcerative Colitis a. Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation b. Current stoma or impending need for colostomy or ileostomy c. Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase d. Previous total proctocolectomy or subtotal colectomy

Design outcomes

Primary

Measure	Time frame
a. Assess the proportion of participants reporting treatment emergent adverse events, serious adverse events, adverse events leading to discontinuation, and markedly abnormal laboratory values b. Assess the Proportion of Participants with Endoscopic Response as assessed by SES CD score. c. Assess the Proportion of Participants Endoscopic Improvement as assessed by MES. d. Assess the Proportion of Participants with Clinical Remission as assessed by CDAI score. e. Assess the Proportion of Participants with Clinical Remission by endoscopy, rectal bleeding and stool frequencyTimepoint: a. Time Frame Up to 13 weeks b. Time Frame 13 weeks. c. Time Frame 12 weeks d. Time Frame 13 weeks e. Time Frame 12 weeks	—

Measure

Time frame

a. Assess the proportion of participants reporting treatment emergent adverse events, serious adverse events, adverse events leading to discontinuation, and markedly abnormal laboratory values b. Assess the Proportion of Participants with Endoscopic Response as assessed by SES CD score. c. Assess the Proportion of Participants Endoscopic Improvement as assessed by MES. d. Assess the Proportion of Participants with Clinical Remission as assessed by CDAI score. e. Assess the Proportion of Participants with Clinical Remission by endoscopy, rectal bleeding and stool frequencyTimepoint: a. Time Frame Up to 13 weeks b. Time Frame 13 weeks. c. Time Frame 12 weeks d. Time Frame 13 weeks e. Time Frame 12 weeks

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Secondary

Measure	Time frame
a. Assess the Proportion of Participants with Clinical Remission as assessed by CDAI score. b. Assess the Proportion of Participants with Clinical Remission by endoscopy rectal bleeding and stool frequency. c. Assess the Proportion of Participants with Symptomatic remission as assessed by patient reported outcomes d. Assess the Proportion of Participants with Clinical Response as assessed by CDAI score. e. Assess the Proportion of Participants with Clinical Response as assessed by MMCS. f. Assess the Proportion of Participants with Endoscopic and Clinical Response by SES CD and clinical response as assessed by CDAI score. g. Assess the Proportion of Participants with Histologic Response as assessed by the RHI. h. Assess the Proportion of Participants with Histologic Remission as assessed by the RHI. i. Assess the Proportion of Participants with Histologic Endoscopic Mucosal Improvement as assessed by the Geboes score and MES. Timepoint: a. Time Frame: 13 weeks b. Time Frame: 12 weeks c. Time Frame: Up to 13 weeks d. Time Frame: 13 weeks e. Time Frame: 12 weeks f. Time Frame: 13 weeks g. Time Frame: 12 weeks h. Time Frame: 12 weeks i. Time Frame: 12 weeks ;j. Characterize the Change in Endoscopy as assessed by SES CD. k. Characterize the Change in Endoscopy Score as assessed by MES. l. Characterize the Change in Histology Score assessed by GHAS and RHI. m. Characterize the Change in Histology Score as assessed by Geobes, RHI and NHI n. Assess the Pharmacokinetics of Investigational DrugTimepoint: j. Time Frame: 13 weeks k. Time Frame: 12 weeks l. Time Frame: 13 weeks m. Time Frame: 12 weeks n. Time Frame: Up to 13 weeks	—

Measure

Time frame

a. Assess the Proportion of Participants with Clinical Remission as assessed by CDAI score. b. Assess the Proportion of Participants with Clinical Remission by endoscopy rectal bleeding and stool frequency. c. Assess the Proportion of Participants with Symptomatic remission as assessed by patient reported outcomes d. Assess the Proportion of Participants with Clinical Response as assessed by CDAI score. e. Assess the Proportion of Participants with Clinical Response as assessed by MMCS. f. Assess the Proportion of Participants with Endoscopic and Clinical Response by SES CD and clinical response as assessed by CDAI score. g. Assess the Proportion of Participants with Histologic Response as assessed by the RHI. h. Assess the Proportion of Participants with Histologic Remission as assessed by the RHI. i. Assess the Proportion of Participants with Histologic Endoscopic Mucosal Improvement as assessed by the Geboes score and MES. Timepoint: a. Time Frame: 13 weeks b. Time Frame: 12 weeks c. Time Frame: Up to 13 weeks d. Time Frame: 13 weeks e. Time Frame: 12 weeks f. Time Frame: 13 weeks g. Time Frame: 12 weeks h. Time Frame: 12 weeks i. Time Frame: 12 weeks ;j. Characterize the Change in Endoscopy as assessed by SES CD. k. Characterize the Change in Endoscopy Score as assessed by MES. l. Characterize the Change in Histology Score assessed by GHAS and RHI. m. Characterize the Change in Histology Score as assessed by Geobes, RHI and NHI n. Assess the Pharmacokinetics of Investigational DrugTimepoint: j. Time Frame: 13 weeks k. Time Frame: 12 weeks l. Time Frame: 13 weeks m. Time Frame: 12 weeks n. Time Frame: Up to 13 weeks

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Countries

Australia, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Georgia, Germany, India, Israel, Italy, Jordan, Poland, Republic of Moldova, Serbia, Slovakia, Ukraine, United States of America

Contacts

Public ContactDr Radhika Bobba

PSI CRO PHARMA India Private Limited

radhika.bobba@psi-cro.com9844058849

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026