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New hope for kids with severe colitis: drug shows promise in small trial

NCT ID NCT01585155

Disease control Sponsor: Tanabe Pharma Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called TA-650 in 21 children with moderate to severe ulcerative colitis, a condition causing inflammation and sores in the colon. The goal was to see if the drug could reduce disease activity and improve symptoms. Children received the drug by infusion at several time points over 22 weeks, and doctors measured changes using a clinical activity index. The study focused on controlling the disease rather than curing it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

21 people

The number who actually took part.

Start date

Feb 2012

Finished

Sep 2014

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients who have been diagnosed as ulcerative colitis at least 3 months prior to screening. * Have active ulcerative colitis despite adequate conventional therapy. Exclusion Criteria: * Patients who have severe pancolitis. * Patients who have undergone surgery for ulcerative colitis within 8 weeks before enrollment or who were judged to require surgery for ulcerative colitis at enrollment. * Patients who have a history of treatment with infliximab or other biologic products (anti-TNFα agents, anti-IL-6 agents, etc.).

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease 1 Pediatric ulcerative colitis ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pediatric ulcerative colitis

Contacts and locations

Locations

  • Investigational site

    Chūbu, Japan

  • Investigational site

    Hokkaido, Japan

  • Investigational site

    Hokuriku, Japan

  • Investigational site

    Kanto, Japan

  • Investigational site

    Kinki, Japan

  • Investigational site

    Kyusyu, Japan

  • Investigational site

    Tōhoku, Japan

More trials for these conditions

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