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New drug cocktail aims to tame stubborn IBD

NCT ID NCT07487311

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether combining guselkumab with JAK inhibitors (upadacitinib or tofacitinib) can help people with inflammatory bowel disease that hasn't improved with other treatments. About 80 participants will receive the drug combination and be monitored for 12 and 52 weeks to see if their symptoms and gut inflammation improve. The goal is to find a new option for those with limited choices.

What this could mean

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

Active substance
guselkumab and JAK inhibitors (upadacitinib or tofacitinib)
What this could lead to
If it works, this combination could offer a new treatment option for people with inflammatory bowel disease that hasn't responded to other therapies.
What could go wrong
This is a small, early-phase study with only 80 participants, so results may not apply to everyone. Combining two strong drugs also raises the risk of side effects like infections.

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.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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.

Who is studied

Moderate to severe active Inflammatory bowel disease

Ages

14 to 80 years

Sex

Anyone

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: * Age 14-80 years with confirmed diagnosis of IBD; * Meeting the definition of refractory IBD (1. Failure of at least two biologics with different mechanisms of action; 2. Crohn's disease with recurrence after two or more intestinal resections; 3. Complex perianal disease despite treatments 1 and 2); * Moderate to severe active IBD (CD: CDAI 220-450, SES-CD ≥6 or isolated ileal disease ≥4; UC: Baseline modified Mayo score (mMayo) of 4-9, rectal bleeding score ≥1, endoscopic score ≥2); * Signed informed consent. Exclusion Criteria: * Active infection, abscess, malignancy, severe cardiopulmonary disease, pregnancy or lactation; * History of thromboembolism, severe hepatic or renal insufficiency, severe cytopenia; * Prior intolerance to JAK inhibitors or IL-23 inhibitors.

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease

As listed by the trial registrant

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

Inflamatory bowel disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

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