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

Toray Industries

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Placebo; Drug: TRK-170

Study type: Interventional

Funder types: Industry

Identifiers

NCT01345799

170CDT01

Details and patient eligibility

About

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

Enrollment: 123 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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123 participants in 4 patient groups, including a placebo group

TRK-170 Low Dose

Experimental group

Treatment:

Drug: TRK-170

TRK-170 Middle Dose

Experimental group

Treatment:

Drug: TRK-170

TRK-170 High Dose

Experimental group

Treatment:

Drug: TRK-170

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo