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Clinical Trials/EUCTR2017-000100-20-BE
EUCTR2017-000100-20-BEActive, not recruitingPhase 1

Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC)

SCS Boehringer Ingelheim Comm. V0 sites10 target enrollmentStarted: March 17, 2017Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
10
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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
  • •- Naïve or experienced to TNF antagonists (but have not failed that treatment due to primary non-response or loss of response)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 9
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

  • •- Patients who have previously failed treatment with any TNF antagonist due to primary non-response or loss of response
  • •- Prior use of any other biological treatment in the past (integrin inhibitors, IL12/23 or IL23 inhibitors, any other 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

Investigators

Sponsor
SCS Boehringer Ingelheim Comm. V

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