At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 21 enrolled

Drug / intervention

TA-650drug

Likely dose

TA-650 5 mg/kgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01585155

NCT01585155Phase 3Completed

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Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis.

Tanabe Pharma Corporation·interventional·Posted Apr 25, 2012·Updated Jan 7, 2026

In Brief

A Phase 3 clinical trial evaluating TA-650 for Pediatric Ulcerative Colitis. Completed, enrolled 21 participants across 7 sites.

Detailed Summary

The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity index (CAI) score and other evaluation indicators in pediatric patients with moderate to severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2, and 6, and then every 8 weeks at weeks 14 and 22. The safety and pharmacokinetics are also evaluated.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPediatric Ulcerative Colitis

CountriesJapan

Collaborators--

Timeline

Phase 3CompletedFinished

201220132014201520162017201820192020202120222023202420252026

Enrollment StartFeb 2012

First PostedApr 2012

Primary CompletionSep 2014

TodayJul 2026

First PostedApr 25, 2012

Enrollment StartFeb 1, 2012

Primary CompletionSep 1, 2014

TodayJul 2, 2026

Enrollment to primary: 2.6 yearsPosted 14.2 years ago

Interventions

TA-650drug

TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Weeks 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 22.