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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2019-10-24

Brief Summary

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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

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Detailed Description

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Conditions

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Colitis, Ulcerative

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spesolimab

Group Type EXPERIMENTAL

Spesolimab

Intervention Type DRUG

12 weeks treatment

Interventions

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Spesolimab

12 weeks treatment

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No