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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	2 June 2025
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
Address:
Telephone:
Email:
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

Drug: Guselkumab Dose 1

Drug: Ustekinumab

Drug: Guselkumab Dose 5

Drug: Guselkumab Dose 4

Drug: Guselkumab Dose 2

Drug: Guselkumab Dose 3

Drug: Placebo

Primary Outcome(s)

Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 [Time Frame: Weeks 48]

Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 [Time Frame: Weeks 48]

Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 [Time Frame: Weeks 48]

Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 [Time Frame: Weeks 48]

Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12 [Time Frame: Week 12]

Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12 [Time Frame: Week 12]

Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12 [Time Frame: Week 12]

Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12 [Time Frame: Week 12]

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

Secondary Outcome(s)

Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 12 [Time Frame: At Week 12]

Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Endoscopic Remission at Week 48 [Time Frame: At Week 48]

Global: GALAXI 2 and 3: Percentage of Participants With Clinical Response at Week 4 [Time Frame: At Week 4]

Global: GALAXI 2 and 3: Percentage of Participants With Deep Remission at Week 48 [Time Frame: At Week 48]

Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12 [Time Frame: At Week 12]

Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48 [Time Frame: At Week 48]

Regional: GALAXI 2 and 3: Percentage of Participants With Durable Clinical Remission at Week 48 [Time Frame: At Week 48]

Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48 [Time Frame: At Week 48]

Regional: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12 [Time Frame: At Week 12]

GALAXI 1: Percentage of Participants With Clinical-Biomarker Response at Week 12 [Time Frame: At Week 12]

Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Corticosteroid-Free Clinical Remission at Week 48 [Time Frame: At Week 48]

Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 48 [Time Frame: At Week 48]

Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 12 [Time Frame: At Week 12]

Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 12 [Time Frame: At Week 12]

Regional: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48 [Time Frame: At Week 48]

Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 48 [Time Frame: At Week 48]

Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 12 [Time Frame: At Week 12]

GALAXI 1: Percentage of Participants With Endoscopic Response at Week 12 [Time Frame: At Week 12]

Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12 [Time Frame: At Week 12]

GALAXI 1: Percentage of Participants With Clinical Remission at Week 12 [Time Frame: At Week 12]

GALAXI 1: Percentage of Participants With Clinical Response at Week 12 [Time Frame: At Week 12]

GALAXI 1: Percentage of Participants With Patient-Reported Outcome (PRO) 2 Remission at Week 12 [Time Frame: At Week 12]

Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48 [Time Frame: At Week 48]

Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48 [Time Frame: At Week 48]

Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Remission at Week 48 [Time Frame: At Week 48]

Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48 [Time Frame: At Week 48]

Global: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12 [Time Frame: At Week 12]

Regional: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission at Week 48 and Endoscopic Response at Week 48 [Time Frame: At Week 48]

Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48 [Time Frame: At Week 48]

Secondary ID(s)

CR108387

CNTO1959CRD3001

2017-002195-13

2023-504736-18-00

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	07/05/2025
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT03466411

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