A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Guselkumab Dose 1 — DRUG
  Guselkumab will be administered by IV infusion.
• Guselkumab Dose 2 — DRUG
  Guselkumab will be administered by SC injection.
• Guselkumab Dose 3 — DRUG
  Guselkumab will be administered by IV infusion.
• Guselkumab Dose 4 — DRUG
  Guselkumab will be administered by IV infusion.
• Guselkumab Dose 5 — DRUG
  Guselkumab will be by SC injection.
• Guselkumab — DRUG
  Guselkumab will be administered by IV infusion and SC injection.
• Ustekinumab — DRUG
  Ustekinumab will be administered by IV infusion and SC injection.
• Placebo — DRUG
  Placebo will be administered as IV infusion.

Study Details

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

Key Dates

Start date

Apr 13, 2018

Status verified

Jun 2026

Primary completion

Oct 20, 2023

Completion

Jan 28, 2028

Study Design

Enrollment

1,409 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 2 (GALAXI 1): Group 1 (Guselkumab)
  Participants will receive guselkumab (Dose 1) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) phase and continue to receive guselkumab.
• Experimental: Phase 2 (GALAXI 1): Group 2 (Guselkumab)
  Participants will receive guselkumab (Dose 3) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.
• Experimental: Phase 2 (GALAXI 1): Group 3 (Guselkumab)
  Participants will receive guselkumab (Dose 4) by intravenous (IV) infusion, followed by guselkumab (Dose 5) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.
• Active Comparator: Phase 2 (GALAXI 1): Group 4 (Ustekinumab)
  Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE and continue to receive ustekinumab.
• Experimental: Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)
  Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (Ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.
• Experimental: Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)
  Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.
• Active Comparator: Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)
  Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE phase and continue to receive ustekinumab.
• Experimental: Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)
  Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.

Primary Outcome Measure

GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 [ Time Frame: Baseline and Week 12 ]

Locations (108)

Related coverage on Hipa.ai

• Guselkumab Improves Crohn's Disease Activity and Remission in Phase 2/3 Trial
  Guselkumab · May 7, 2025 · ClinicalTrials.gov

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