Crohn's Head-to-Head Assessing Risankizumab Versus Guselkumab for One Year (CHARGE)

  • Research type

    Research Study

  • Full title

    A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab versus Risankizumab in the Treatment of Participants with Moderately to Severely Active Crohn’s Disease

  • IRAS ID

    1013251

  • Contact name

    David Wright

  • Contact email

    GCOUKSubmissions@its.jnj.com

  • Sponsor organisation

    Janssen-Cilag International N.V.

  • Eudract number

    2025-521590-13

  • ISRCTN Number

    ISRCTN39379437

  • Research summary

    Crohn’s disease (CD) is a long-term, progressive (worsens with time) and life-threatening disease of the digestive system. Inflammation due to the disease penetrates the lining of digestive tract and may cause ulcers to form. Although guselkumab and risankizumab are approved treatments, still more information is needed to understand which treatment works better for patients with moderately to severely active CD who did not respond to other treatments.
    Guselkumab and risankizumab are monoclonal antibodies* that blocks interleukin 23 (IL-23)**.
    Blocking the effects of IL-23 helps to reduce the inflammation that occurs in CD.
    *A type of protein designed to recognise and attach to a specific target.
    **A specific type of protein involved in inflammation.
    In this study, researchers want to assess how well guselkumab works compared to risankizumab in patients with moderately to severely active CD.

  • REC name

    Wales REC 1

  • REC reference

    26/WA/0033

  • Date of REC Opinion

    17 Mar 2026

  • REC opinion

    Further Information Favourable Opinion