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

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 - GALAXI

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002195-13-CZ

Enrollment

1340

Registered

2018-04-20

Start date

2018-06-19

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderately to Severely Active Crohn's Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: guselkumab Product Code: CNTO1959 Pharmaceutical Form: Solution for infusion in pre-filled syringe INN or Proposed INN: GUSELKUMAB Current Sponsor code: CNTO 1959 Concentration unit: mg/

Eligibility

Sex/Gender

All

Inclusion 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 rest results within the protocol specified parameters - A female participant of childbearing potential must have negative urine pregnancy test result at screening and baseline -Demonstrated intolerance or inadequate response to conventional or to biological therapy for CD Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1206 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 134

Exclusion criteria

Exclusion criteria: - Current diagnosis of ulcerative colitis or indeterminate colitis - Has complications of Crohn's disease, such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation -Unstable doses of concomitant Crohn's disease therapy - Receipt of Crohn's disease approved biological agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol - Any medical contraindications preventing study participation

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase 2: - To evaluate the clinical efficacy of guselkumab in participants with Crohn’s disease - To evaluate the safety of guselkumab Phase 3: - To evaluate the clinical and endoscopic efficacy of guselkumab in patients with Crohn's disease - To evaluate the safety of gulsekumab;Secondary Objective: Phase 2: - To evaluate the dose-response of guselkumab to inform dose selection for the Phase 3 portion of this protocol - To evaluate the efficacy of guselkumab on endoscopic improvement - To evaluate the PK, immunogenicity, and pharmacodynamics (PD) of guselkumab therapy Phase 3: - To evaluate the impact of guselkumab on HRQOL - To evaluate the PK, immunogenicity, and PD of guselkumab therapy;Primary end point(s): Phase 2: Change from baseline in the Crohn's Disease Activity Index (CDAI) score at Week 12 Phase 3: Global co-primary endpoints: - clinical response at Week 12 and clinical remission at Week 48 - clinical response at Week 12 and endoscopic response at Week 48 Regional co-primary endpoints: - clinical remission at Week 12 - endoscopic response at Week 12 ;Timepoint(s) of evaluation of this end point: Global: Week 12 and Week 48 Regional: Week 12	—

Measure

Time frame

Main Objective: Phase 2: - To evaluate the clinical efficacy of guselkumab in participants with Crohn’s disease - To evaluate the safety of guselkumab Phase 3: - To evaluate the clinical and endoscopic efficacy of guselkumab in patients with Crohn's disease - To evaluate the safety of gulsekumab;Secondary Objective: Phase 2: - To evaluate the dose-response of guselkumab to inform dose selection for the Phase 3 portion of this protocol - To evaluate the efficacy of guselkumab on endoscopic improvement - To evaluate the PK, immunogenicity, and pharmacodynamics (PD) of guselkumab therapy Phase 3: - To evaluate the impact of guselkumab on HRQOL - To evaluate the PK, immunogenicity, and PD of guselkumab therapy;Primary end point(s): Phase 2: Change from baseline in the Crohn's Disease Activity Index (CDAI) score at Week 12 Phase 3: Global co-primary endpoints: - clinical response at Week 12 and clinical remission at Week 48 - clinical response at Week 12 and endoscopic response at Week 48 Regional co-primary endpoints: - clinical remission at Week 12 - endoscopic response at Week 12 ;Timepoint(s) of evaluation of this end point: Global: Week 12 and Week 48 Regional: Week 12

—

Secondary

Measure	Time frame
Secondary end point(s): Phase 2: - Clinical remission at Week 12 (defined as CDAI score <150) - Clinical response at Week 12 (defined as =100-point reduction from baseline in CDAI score or CDAI score <150) - PRO-2 remission at Week 12 (defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score) - Clinical-biomarker response at Week 12 (clinical response based on CDAI score and reduction from baseline in CRP or fecal calprotectin) - Endoscopic response at Week 12 (measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD is based on the evaluation of 4 endoscopic components across 5 ileocolonic segments, with a total score ranging from 0 to 56.) Phase 3: Global Major Secondary Endpoints: Short-term efficacy, guselkumab versus placebo - Clinical response at Week 4 - Clinical remission at Week 12 - Endoscopic response at Week 12 - Fatigue response at Week 12 - Clinical remission at Week 12 and endoscopic response at Week 12 - Endoscopic remission (Global definition) at Week 12 Long-term, guselkumab versus placebo: - Clinical response at Week 12 and corticosteroid-free clinical remission at Week 48 - Clinical response at Week 12 and endoscopic remission (Global definition) at Week 48 Long-term, guselkumab versus ustekinumab: - Clinical remission at Week 48 - Endoscopic response at Week 48 - Clinical remission at Week 48 and endoscopic response at Week 48 - Endoscopic remission (Global definition) at Week 48 - Deep remission (Global definition) at Week 48 Regional Major Secondary Endpoints: Short-term efficacy, guselkumab versus placebo: - PRO-2 remission at Week 12 - Fatigue response at Week 12 - Endoscopic remission (Regional definition) at Week 12 Long-term, guselkumab versus placebo: - Corticosteroid-free clinical remission at Week 48 - Endoscopic response at Week 48 Long-term, guselkumab versus ustekinumab: - Endoscopic remission (Regional definition) at Week 48 - Clinical remission at Week 48 - Endoscopi	—

Measure

Time frame

Secondary end point(s): Phase 2: - Clinical remission at Week 12 (defined as CDAI score <150) - Clinical response at Week 12 (defined as =100-point reduction from baseline in CDAI score or CDAI score <150) - PRO-2 remission at Week 12 (defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score) - Clinical-biomarker response at Week 12 (clinical response based on CDAI score and reduction from baseline in CRP or fecal calprotectin) - Endoscopic response at Week 12 (measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD is based on the evaluation of 4 endoscopic components across 5 ileocolonic segments, with a total score ranging from 0 to 56.) Phase 3: Global Major Secondary Endpoints: Short-term efficacy, guselkumab versus placebo - Clinical response at Week 4 - Clinical remission at Week 12 - Endoscopic response at Week 12 - Fatigue response at Week 12 - Clinical remission at Week 12 and endoscopic response at Week 12 - Endoscopic remission (Global definition) at Week 12 Long-term, guselkumab versus placebo: - Clinical response at Week 12 and corticosteroid-free clinical remission at Week 48 - Clinical response at Week 12 and endoscopic remission (Global definition) at Week 48 Long-term, guselkumab versus ustekinumab: - Clinical remission at Week 48 - Endoscopic response at Week 48 - Clinical remission at Week 48 and endoscopic response at Week 48 - Endoscopic remission (Global definition) at Week 48 - Deep remission (Global definition) at Week 48 Regional Major Secondary Endpoints: Short-term efficacy, guselkumab versus placebo: - PRO-2 remission at Week 12 - Fatigue response at Week 12 - Endoscopic remission (Regional definition) at Week 12 Long-term, guselkumab versus placebo: - Corticosteroid-free clinical remission at Week 48 - Endoscopic response at Week 48 Long-term, guselkumab versus ustekinumab: - Endoscopic remission (Regional definition) at Week 48 - Clinical remission at Week 48 - Endoscopi

—

Countries

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

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026