This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Drug: Spesolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03100864

1368-0004

2017-000100-20 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC

Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 - 75 years at screening
• Diagnosis of UC >= 3 months prior to screening.
• Moderately to severely active UC as confirmed by Mayo Score ≥6
• Receiving conventional, non-biologic therapy for UC.
• Negative colon cancer screening
• Further inclusion criteria apply

Exclusion criteria

• Prior use of any biological treatment in the past (e.g.integrin inhibitors, IL12/23 or IL23 inhibitors, any investigational biological drugs)
• Extensive colonic resection
• Evidence of infection with C. difficile or other intestinal pathogen < 30 days prior to screening
• Active or latent tuberculosis
• Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Spesolimab

Experimental group

Treatment:

Drug: Spesolimab