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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT03466411
• Date of registration: 08/03/2018
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease GALAXI
• Scientific title: A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
• Date of first enrolment: April 13, 2018
• Target sample size: 1409
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03466411
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Latvia, Lebanon, Lithuania, Macedonia, The Former Yugoslav Republic of, Malaysia, Netherlands, New Zealand, North Macedonia, Norway, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Guselkumab Dose 1

Drug: Ustekinumab

Drug: Guselkumab Dose 2

Drug: Guselkumab Dose 3

Drug: Guselkumab Dose 4

Drug: Guselkumab Dose 5

Drug: Placebo

Drug: Guselkumab

Primary Outcome(s)

Phase 3: Clinical Response at Week 12 and Clinical Remission at Week 48 [Time Frame: Baseline to Week 48]

Phase 3: Clinical Response at Week 12 and Endoscopic Response at Week 48 [Time Frame: Baseline to Week 48]

Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

Phase 2 and Phase 3: Patient-Reported Outcome (PRO)-2 Remission at Week 12 [Time Frame: Week 12]

Phase 2: Clinical Remission at Week 12 [Time Frame: Week 12]

Phase 2: Clinical-Biomarker Response at Week 12 [Time Frame: Week 12]

Phase 3: Endoscopic Response at Week 12 [Time Frame: Week 12]

Phase 2: Endoscopic Response at Week 12 [Time Frame: Week 12]

Phase 3: Deep Remission at Week 48 [Time Frame: Week 48]

Phase 3: Clinical Response at Week 4 [Time Frame: Week 4]

Phase 3: Endoscopic Response at Week 48 [Time Frame: Week 48]

Phase 3: Clinical Remission at Week 12 [Time Frame: Week 12]

Phase 3: Clinical Remission at Week 48 and Endoscopic Response at Week 48 [Time Frame: Week 48]

Phase 3: Clinical Remission at Week 12 and Endoscopic Response at Week 12 [Time Frame: Week 12]

Phase 3: Clinical Response at Week 12 and Corticosteroid-Free Clinical Remission at Week 48 [Time Frame: Baseline to Week 48]

Phase 2: Clinical Response at Week 12 [Time Frame: Week 12]

Phase 3: Clinical Remission at Week 48 [Time Frame: Week 48]

Phase 3: Fatigue Response at Week 12 [Time Frame: Week 12]

Phase 3: Endoscopic Remission at Week 48 [Time Frame: Week 48]

Phase 3:Clinical Response at Week 12 and Endoscopic Remission at Week 48 [Time Frame: Baseline to Week 48]

Phase 3: Endoscopic Remission at Week 12 [Time Frame: Week 12]

Secondary ID(s)

CNTO1959CRD3001

CR108387

2017-002195-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors