BI 655130 Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223993

Enrollment

550

Registered

2018-08-03

Start date

2018-08-03

Completion date

Unknown

Last updated

2025-07-18

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

Conditions

Ulcerative Colitis

Interventions

investigational material(s) Generic name etc : BI 655130 INN of investigational material : Spesolimab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18 - 75 years, at date of signing informed consent, males or females - Diagnosis of ulcerative colitis equal to or more than 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report - Moderate to severe activity (total MCS 6 to 12 with a RBS equal to or more than 1 AND an SFS equal to or more than 1 AND mESS equal to or more than 2 within 7-28 days prior to first dose) - Endoscopic activity extending proximal to the rectum (equal to or more than 15 cm from anal verge) - Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFalpha agonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past

Exclusion criteria

Exclusion criteria: - Evidence of abdominal abscess at screening - Evidence of fulminant colitis or toxic megacolon at screening - Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine

Design outcomes

Primary

Measure	Time frame
efficacy Proportion of patients with Clinical Remission [ Time Frame: Up to week 12 ]	—

Secondary

Measure	Time frame
efficacy Part 1 and 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline [ Time Frame: Up to baseline and week 12 ] efficacy Part 1 and 2: Proportion of patients with combined Mucosal healing and histologic remission [ Time Frame: Up to week 12 ] efficacy Part 1: Proportion of patients with Mucosal Healing [ Time Frame: Up to week 12 ] efficacy Part 1: Proportion of patients with Clinical response [ Time Frame: Up to week 12 ] efficacy Part 2: Proportion of patients with Mucosal Healing [ Time Frame: Up to week 12 ] efficacy Part 2: Proportion of patients with Clinical response [ Time Frame: Up to week 12 ]	—

Measure

Time frame

efficacy Part 1 and 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline [ Time Frame: Up to baseline and week 12 ] efficacy Part 1 and 2: Proportion of patients with combined Mucosal healing and histologic remission [ Time Frame: Up to week 12 ] efficacy Part 1: Proportion of patients with Mucosal Healing [ Time Frame: Up to week 12 ] efficacy Part 1: Proportion of patients with Clinical response [ Time Frame: Up to week 12 ] efficacy Part 2: Proportion of patients with Mucosal Healing [ Time Frame: Up to week 12 ] efficacy Part 2: Proportion of patients with Clinical response [ Time Frame: Up to week 12 ]

—

Countries

Asia except Japan, Europe, Japan, North America, Oceania

Outcome results

None listed

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