Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002902-29-BE

Enrollment

120

Registered

2013-09-20

Start date

2014-01-09

Completion date

Unknown

Last updated

2017-01-09

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

Conditions

Crohn's disease

Interventions

Product Code: BI 655066 10 mg/ml Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: BI 655066 Other descriptive name: BI 655066 Concentration unit: mg/ml milligram(s)/mil

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate efficacy of BI 655066 in inducing clinical remission, defined as CDAI [Crohn's Disease Activity Index] <150 after 12 weeks of treatment.;Secondary Objective: To evaluate efficacy, safety and pharmacokinetics of BI 655066 therapy in Crohn's disease.;Primary end point(s): 1: Proportion of patients achieving clinical remission at week 12, defined as a CDAI score of < 150. ;Timepoint(s) of evaluation of this end point: 1: week 12	—

Measure

Time frame

Main Objective: To evaluate efficacy of BI 655066 in inducing clinical remission, defined as CDAI [Crohn's Disease Activity Index] <150 after 12 weeks of treatment.;Secondary Objective: To evaluate efficacy, safety and pharmacokinetics of BI 655066 therapy in Crohn's disease.;Primary end point(s): 1: Proportion of patients achieving clinical remission at week 12, defined as a CDAI score of < 150. ;Timepoint(s) of evaluation of this end point: 1: week 12

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Secondary

Measure	Time frame
Secondary end point(s): 1: Proportion of patients achieving clinical response defined by either a CDAI score of 50 % reducton from baseline). 4: Proportion of patients achieving mucosal healing, defined as the absence of mucosal ulceration. 5: Proportion of patients achieving deep remission, defined as clinical remission and CDEIS remission. 6: Proportion of patients achieving clinical response, defined by either a PRO-2 score of <8 or a reduction from baseline of at least 8 points. 7: Change in SES-CD score at wkke 12. ;Timepoint(s) of evaluation of this end point: 1: week 12 2: week 12 3: week 12 4: week 12 5: week 12 6: week 12 7: week 12	—

Measure

Time frame

Secondary end point(s): 1: Proportion of patients achieving clinical response defined by either a CDAI score of 50 % reducton from baseline). 4: Proportion of patients achieving mucosal healing, defined as the absence of mucosal ulceration. 5: Proportion of patients achieving deep remission, defined as clinical remission and CDEIS remission. 6: Proportion of patients achieving clinical response, defined by either a PRO-2 score of <8 or a reduction from baseline of at least 8 points. 7: Change in SES-CD score at wkke 12. ;Timepoint(s) of evaluation of this end point: 1: week 12 2: week 12 3: week 12 4: week 12 5: week 12 6: week 12 7: week 12

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Countries

Belgium, Canada, Germany, Ireland, Korea, Republic of, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com+18002430127

Outcome results

None listed

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