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New hope for kids with Crohn's: drug shows promise in small trial

NCT ID NCT01580670

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 (also known as infliximab) in 14 children with moderate to severe Crohn's disease. The drug was given as an IV infusion to reduce inflammation and control symptoms. The goal was to see if it could lower disease activity scores and improve the children's health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TA-650 (infliximab), a drug that blocks inflammation
What this could lead to
If successful, this could provide a treatment option to control symptoms and improve quality of life for children with Crohn's disease.
What could go wrong
This is a small, completed Phase 3 trial with only 14 participants, so results may not apply to all children. Infliximab can have serious side effects like infections or allergic reactions.

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

14 people

The number who actually took part.

Start date

Mar 2012

Finished

Mar 2015

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 Crohn's disease at least 3 months prior to screening. * Have active Crohn's disease despite adequate conventional therapy. Exclusion Criteria: * Patients with severe intestinal strictures (strictures which may affect the number of defecations, etc., or dilation of the colon or strictures in the proximal small bowel observed on barium radiograph, or strictures precluding the insertion of endoscope), a diagnosis of short bowel syndrome, or previous stoma surgery. * Patients who have a history of treatment with infliximab, or biological products (anti-TNFα agents and anti-IL-6 agents, etc.).

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Conditions

The condition(s) this trial relates to.

Crohn disease Pediatric Crohn's disease

As listed by the trial registrant

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

Pediatric Crohn's disease

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