Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy

Phase 2

Completed

• Conditions: bowel inflammation; ulcerative colitis; 10017969

• Registration Number: NL-OMON47670
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

- 18 * 60 years at screening and randomisation
- Diagnosis of ulcerative colitis *5 months prior to screening
- ReceivingTNFi treatment with doses (i.e. dose and dosing interval) unchanged for *4 months prior to randomisation
- Mild or moderate disease activity, defined as total Mayo Score (MCS) (*10)
- Further criteria apply, refer to protocol section 3.3.2.

Exclusion Criteria

- Prior use of more than one different TNF inhibitor or vedolizumab
- Extensive colonic resection
- Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to screening
- Active or latent tuberculosis
- Further criteria apply, refer to protocol section 3.3.3

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>see protocol 5.1.1.<br /><br><br /><br>Mucosal healing (MCS mESS *1) at Week 8</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>See protocol 5.1.2<br /><br><br /><br>Clinical remission based on Mayo score (total MCS *2 points, and all subscores<br /><br>*1 point) at Week 8<br /><br>Histological remission (Robarts (RHI) score *6) at Week 8<br /><br>Clinical remission based on Mayo score (total MCS *2 points, and all subscores<br /><br>*1 point)at Week 12<br /><br>Mucosal healing (MCS mESS *1) at Week 12<br /><br>Histological remission (Robarts (RHI) score *6) at Week 12<br /><br>Modified clinical remission based on Mayo score (total modified MCS *2 and: RBS<br /><br>=0,<br /><br>Stool Frequency Score (SFS) =0 or 1 and drop *1 from baseline, AND mESS *1) at<br /><br>Week 8<br /><br>Modified clinical remission based on Mayo score (total modified MCS *2 and: RBS<br /><br>=0,SFS =0 or 1 and drop *1 from baseline, AND mESS *1) at Week 12</p><br>