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New drug guselkumab shows promise for Crohn's in early trial

NCT ID NCT04397263

Disease control Sponsor: Janssen Pharmaceutical K.K. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tested the safety of guselkumab in 38 people with moderate-to-severe Crohn's disease. Participants received the drug first through an IV, then as injections. The main goal was to track side effects, but researchers also looked at whether symptoms improved. Results could help determine if guselkumab is a safe option for controlling Crohn's disease.

What this could mean

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

Active substance
Guselkumab (a drug given by IV and then injection)
What this could lead to
If successful, this could provide a new treatment option to help control moderate-to-severe Crohn's disease symptoms and reduce inflammation.
What could go wrong
This is a small, open-label study focused on safety, so results may not confirm effectiveness. Side effects like infections or injection reactions 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

Phase 3

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

Participants

38 people

The number who actually took part.

Started

Jun 2020

Finished

Sep 2025

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

18 years and older

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: * Have Crohn's Disease (CD) or fistulizing CD of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy * Have moderate to severe CD as assessed by CDAI components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence * Have screening laboratory test results within the protocol specified parameters * A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline * Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD Exclusion Criteria: * Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation * Unstable doses of concomitant Crohn's disease therapy * Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted time frame as specified in the protocol * Prior exposure to p40 inhibitors or p19 inhibitors * Any medical contraindications preventing study participation

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

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

Crohns disease

Contacts and locations

Locations

  • Asahikawa Medical University Hospital

    Hokkaido, 078 8510, Japan

  • Hitachi General Hospital

    Hitachi, 317-0077, Japan

  • Hyogo Medical University Hospital

    Nishinomiya Shi, 663 8501, Japan

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113 8519, Japan

  • Ishida Clinic of IBD and Gastroenterology

    Ōita, 870 0823, Japan

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861-8520, Japan

  • Jichi Medical University Hospital

    Shimotsuke, 329-0498, Japan

  • KOKIKAI Tokatsu Tsujinaka Hospital

    Abiko, 270-1168, Japan

  • Kenseikai Dongo Hospital

    Nara, 635-0022, Japan

  • Kishiwada Tokushukai Hospital

    Kishiwada, 5960042, Japan

  • Kitasato University Hospital

    Sagamihara, 252-0375, Japan

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Kyorin University Hospital

    Mitaka, 181-8611, Japan

  • National Center for Global Health and Medicine

    Shinjuku- Ku, 162-8655, Japan

  • National Hospital Organization Toyohashi Medical Center

    Toyohashi, 441-8570, Japan

  • Ofuna Chuo Hospital

    Kamakura, 247-0056, Japan

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686, Japan

  • Saga University Hospital

    Saga, 849-8501, Japan

  • Saitama Medical Center

    Saitama, 350 8550, Japan

  • Sapporo Tokushukai Hospital

    Sapporo, 004-0041, Japan

  • Sendai Kosei Hospital

    Sendai Miyagi, 9810914, Japan

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida Ku, 130 8575, Japan

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, 162-8666, Japan

  • Toyama Prefectural Central Hospital

    Toyama, 9308550, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.