Could a Two-Drug combo tame Crohn's in kids?
NCT ID NCT07424040
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will compare two treatments for children with moderate to severe Crohn's disease: infliximab alone or infliximab plus azathioprine. About 154 children will receive one of the two regimens for over a year. The goal is to see if the combination leads to higher remission rates and fewer complications without increasing side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- infliximab and azathioprine
- What this could lead to
- If successful, this could show that combining two drugs helps more children with Crohn's disease reach and stay in remission without extra safety risks.
- What could go wrong
- This trial hasn't started yet and is relatively small (154 children). It compares existing drugs, so it's not a breakthrough—just a refinement. Side effects like infections or liver issues are possible.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 154 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 18 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Diagnose Crohn's disease based on the 2019 Expert Consensus for the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease. * The baseline Pediatric Crohn's Disease Activity Index (PCDAI) value is ≥ 30. * None of the patients had received treatment with azathioprine, 6-mercaptopurine, or anti-TNF biological agents before. * Patients who received the following adjunctive treatments also meet the participation criteria: acid-suppressing drugs (if the dose was stable for at least 2 weeks before enrollment, it is applicable), enteral nutrition (with a stable plan for 2 weeks). Rectal, intravenous, or oral corticosteroids are not allowed, and they must be discontinued at least 2 weeks before enrollment. Exclusion Criteria: * Suffering from short bowel syndrome, ostomy surgery, symptomatic stenosis, abscess, or a recent history of abdominal surgery (within 6 months) * History of tuberculosis or other granulomatous infections, positive chest imaging or positive tuberculin skin test * Recent opportunistic infection history (within 6 months), active hepatitis B or C infection, human immunodeficiency virus infection * Multiple sclerosis, cancer * Homozygous mutations in NUDT15 or TPMT genes, or heterozygous mutations in at least one of the above genes
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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JinHua Maternal & Child Health Care Hospital
Jinhua, Zhejiang, 321000, China
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Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
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The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
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The First People's Hospital of Yunnan
Kunming, Yunnan, 650000, China
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