A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's disease

An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001834-15-ES

Enrollment

Registered

2015-06-18

Start date

2015-09-24

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease MedDRA version: 18.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856

Interventions

Product Code: BI 655066 10 mg/ml Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: not available yet Current Sponsor code:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with Crohn`s disease, who have successfully completed the preceding trial 1311.6. Successful treatment is defined as: a. Completion of period 2 in 1311.6 with a clinical response (drop in Crohn's Disease Activity Index from baseline by =100) but no remission (Crohn's Disease Activity Index =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Patients who were not compliant with key study procedures (colonoscopy, treatment compliance, endpoint assessment, contraception measures) in preceding trial 1311.6 - Patients who could not tolerate BI 655066 treatment for tolerability or safety reasons in the preceding trial - Are pregnant, nursing, or planning pregnancy while enrolled in the study, or within 15 weeks after receiving the last dose of study medication. - Patients must agree not to receive a live virus or bacterial or Bacille Calmette-Guérin vaccination during the study or up to 12 months after the last administration of study drug. - Patients who have developed malignancy, or suspicion of active malignant disease during the preceding trial - Are intending to participate in any other study using an investigational agent or procedure during participation in this study. - Cannot adhere to the concomitant medication requirements

Design outcomes

Primary

Measure	Time frame
Primary end point(s): 1: Incidence of drug-related adverse events;Timepoint(s) of evaluation of this end point: 1: 216 weeks;Main Objective: To investigate long-term safety of BI 655066, in patients with moderately to severely active Crohn`s disease, who showed a clinical response or remission on previous treatment with BI 655066 and are now receiving long term treatment.;Secondary Objective: To further investigate long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of BI 655066.	—

Measure

Time frame

Primary end point(s): 1: Incidence of drug-related adverse events;Timepoint(s) of evaluation of this end point: 1: 216 weeks;Main Objective: To investigate long-term safety of BI 655066, in patients with moderately to severely active Crohn`s disease, who showed a clinical response or remission on previous treatment with BI 655066 and are now receiving long term treatment.;Secondary Objective: To further investigate long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of BI 655066.

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Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none	—

Countries

Belgium, Canada, Germany, Korea, Republic of, Netherlands, Spain, United States

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co. KG

+34 934045100

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026