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CompletedNCT01345799Updated Jun 12, 2014

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

A Phase 2 interventional study of TRK-170 and Placebo in Crohn's Disease, sponsored by Toray Industries, Inc. Completed at 13 sites in 13 countries. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-06-12.

Sponsored by Toray Industries, Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
123
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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
02

Conditions studied

  • Crohn's Disease

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Keywords

  • Crohn's Disease Activity Index
  • Crohn's Disease
  • Inflammatory Bowel Disease
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 123 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Toray Industries, Inc is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient has had a clinically significant illness prior to screening
  • Patient with clinically significant deviations in laboratory values
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    TRK-170 Low Dose

    Drug: TRK-170

  • Experimental
    TRK-170 Middle Dose

    Drug: TRK-170

  • Experimental
    TRK-170 High Dose

    Drug: TRK-170

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugTRK-170
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Crohn's Disease Activity Index

    8 weeks (treatment), 4 weeks (follow-up)

    Time frame: 12 weeks

07

Study locations

13 sites
  • Belgium
    Belgium, Belgium
  • Bulgaria
    Bulgaria, Bulgaria
  • Czech Republic
    Czech Republic, Czech Republic
  • France
    France, France
  • Hungary
    Hungary, Hungary
  • Latvia
    Latvia, Latvia
  • The Netherlands
    The Netherlands, Netherlands
  • Norway
    Norway, Norway
  • Poland
    Poland, Poland
  • Romania
    Romania, Romania
  • Serbia
    Serbica, Serbia
  • Sweden
    Sweden, Sweden
  • Ukraine
    Ukraine, Ukraine
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01345799
Lead sponsor
Toray Industries, Inc
Responsible party
Sponsor
First posted
May 2, 2011
Start date
Apr 2011
Completion
Apr 2014
Last update
Jun 12, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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