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

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Ustekinumab; Drug: Guselkumab Dose 3; Drug: Guselkumab; Drug: Guselkumab Dose 5; Drug: Guselkumab Dose 2; Drug: Guselkumab Dose 1; Drug: Placebo; Drug: Guselkumab Dose 4

Study type: Interventional

Funder types: Industry

Identifiers

NCT03466411

CNTO1959CRD3001 (Other Identifier)

2023-504736-18-00 (Registry Identifier)

CR108387

2017-002195-13 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.

Enrollment: 1,409 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have Crohn's disease (CD) or fistulizing Crohn's disease 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, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
• 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

• Current diagnosis of ulcerative colitis or indeterminate colitis
• Has complications of Crohn's disease, 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 timeframe as specified in the protocol
• Any medical contraindications preventing study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,409 participants in 8 patient groups

Phase 2 (GALAXI 1): Group 1 (Guselkumab)

Experimental group

Description:

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.

Treatment:

Drug: Guselkumab Dose 1

Drug: Guselkumab Dose 2

Phase 2 (GALAXI 1): Group 2 (Guselkumab)

Experimental group

Description:

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.

Treatment:

Drug: Guselkumab Dose 2

Drug: Guselkumab Dose 3

Phase 2 (GALAXI 1): Group 3 (Guselkumab)

Experimental group

Description:

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.

Treatment:

Drug: Guselkumab Dose 4

Drug: Guselkumab Dose 5

Phase 2 (GALAXI 1): Group 4 (Ustekinumab)

Active Comparator group

Description:

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.

Treatment:

Drug: Ustekinumab

Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Ustekinumab

Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)

Experimental group

Description:

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.

Treatment:

Drug: Guselkumab

Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)

Active Comparator group

Description:

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.

Treatment:

Drug: Ustekinumab

Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Ustekinumab