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Clinical Trials/EUCTR2013-002902-29-BE
EUCTR2013-002902-29-BE
Active, not recruiting
Phase 1

A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy.

SCS Boehringer Ingelheim Comm.V0 sites120 target enrollmentSeptember 20, 2013
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ConditionsCrohn's diseaseTherapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Crohn's disease
Sponsor
SCS Boehringer Ingelheim Comm.V
Enrollment
120
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 20, 2013
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
SCS Boehringer Ingelheim Comm.V

Eligibility Criteria

Inclusion Criteria

  • •\- Men or women 18\-75 years at the time of consent.
  • •\- Diagnosis of Crohn's disease at least 3 months prior to screening.
  • •\- Moderate to severe active Crohn's disease, defined as CDAI \>or\=220 and Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 119
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 1

Exclusion Criteria

  • •\- Complications of Crohn's disease such as strictures, stenoses, short gut syndrome, or any other manifestation that might require surgery.
  • •\- Presence of ileostomy or colostomy.
  • •\- Pregnant or nursing women.
  • •\- Signs or symptoms suggestive of active TB.
  • •\- History of malignancy.

Outcomes

Primary Outcomes

Not specified

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