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

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: TRK-170; Drug: Placebo

• Registration Number: NCT01345799
• Lead Sponsor: Toray Industries, Inc

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Study Completion: 2014-04
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-11
• Last Update Posted: 2014-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRK-170 Low Dose	TRK-170	-
TRK-170 Middle Dose	TRK-170	-
TRK-170 High Dose	TRK-170	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Crohn's Disease Activity Index	12 weeks	8 weeks (treatment), 4 weeks (follow-up)

Trial Locations

Locations (13)

Bulgaria; 🇧🇬 Bulgaria, Bulgaria

Ukraine; 🇺🇦 Ukraine, Ukraine

Sweden; 🇸🇪 Sweden, Sweden

France; 🇫🇷 France, France

Czech Republic; 🇨🇿 Czech Republic, Czech Republic

Hungary; 🇭🇺 Hungary, Hungary

The Netherlands; 🇳🇱 The Netherlands, Netherlands

Latvia; 🇱🇻 Latvia, Latvia

Norway; 🇳🇴 Norway, Norway

Poland; 🇵🇱 Poland, Poland

Serbia; 🇷🇸 Serbica, Serbia

Romania; 🇷🇴 Romania, Romania

Belgium; 🇧🇪 Belgium, Belgium