BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

Boehringer Ingelheim

Status and phase: Completed; Phase 3; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Drug: Placebo; Drug: Spesolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03482635

1368-0005

2017-004230-28 (EudraCT Number)

Details and patient eligibility

About

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are

• to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)
• to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)
• To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

Enrollment: 98 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 - 75 years, at date of signing informed consent, males or females
• Diagnosis of ulcerative colitis ≥ 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 ≥ 1 AND an SFS ≥ 1 AND mESS ≥ 2 within 7-28 days prior to first dose)
• Endoscopic activity extending proximal to the rectum (≥ 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 TNFɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study)
• Further inclusion criteria apply

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
• Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 4 patient groups

Group 1- Placebo Group

Experimental group

Treatment:

Drug: Placebo

Group 2- Small Dose Group

Experimental group

Treatment:

Drug: Spesolimab

Group 3- Medium Dose Group

Experimental group

Treatment:

Drug: Spesolimab

Group 4 - High Dose Group

Experimental group

Treatment:

Drug: Spesolimab