A Study of TRK-170 for the Treatment of Crohn's Disease

A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01345799

Enrollment

123

Registered

2011-05-02

Start date

2011-04-30

Completion date

2014-04-30

Last updated

2014-06-12

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

Conditions

Crohn's Disease

Keywords

Crohn's Disease Activity Index, Crohn's Disease, Inflammatory Bowel Disease

Brief summary

In Crohn's Disease Patients * To evaluate the efficacy of TRK-170 * To evaluate the PK characteristics of TRK-170 * To assess the safety of TRK-170

Interventions

DRUGTRK-170

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Patient has a diagnosis of Crohn's Disease before screening * Patient has stable disease activity

Exclusion criteria

* Patient has had a clinically significant illness prior to screening * Patient with clinically significant deviations in laboratory values

Design outcomes

Primary

Measure	Time frame	Description
Crohn's Disease Activity Index	12 weeks	8 weeks (treatment), 4 weeks (follow-up)

Countries

Belgium, Bulgaria, Czechia, France, Hungary, Latvia, Netherlands, Norway, Poland, Romania, Serbia, Sweden, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026