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

NCT ID NCT04397263

Completed Disease control Sponsor: Janssen Pharmaceutical K.K. Source: ClinicalTrials.gov ↗

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.

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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

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