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

• ClinicalTrials.gov Identifier: NCT03466411
• Recruitment Status: Recruiting
• First Posted: March 15, 2018
• Last Update Posted: March 5, 2021
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Tracking Information

• First Submitted Date: March 8, 2018
• First Posted Date: March 15, 2018
• Last Update Posted Date: March 5, 2021
• Actual Study Start Date: April 13, 2018
• Estimated Primary Completion Date: June 3, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 3, 2021)

• Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 [ Time Frame: Baseline and Week 12 ]
  The CDAI score will be assessed by collecting information on 8 different Crohn's disease-related variables, with scores ranging from 0 to approximately 600. A decrease over time indicates improvement in disease activity.
• Phase 3: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
  Clinical remission is defined as CDAI score less than (<) 150 points.
• Phase 3: Endoscopic Response at Week 12 [ Time Frame: Week 12 ]
  Endoscopic Response is 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.

Original Primary Outcome Measures (submitted: March 8, 2018)

• Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 [ Time Frame: Baseline and Week 12 ]
  The CDAI score will be assessed by collecting information on 8 different Crohn's disease-related variables, with scores ranging from 0 to approximately 600. A decrease over time indicates improvement in disease activity.
• Phase 3: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
  Clinical remission is defined as CDAI less than (<) 150 points.

Current Secondary Outcome Measures (submitted: March 3, 2021)

• Phase 2: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
  Clinical remission is defined as CDAI score <150.
• Phase 2: Clinical Response at Week 12 [ Time Frame: Week 12 ]
  Clinical response is defined as greater than or equal to (>=) 100-point reduction from baseline in CDAI score or CDAI score <150.
• Phase 2 and Phase 3: Patient-Reported Outcome (PRO)-2 Remission at Week 12 [ Time Frame: Week 12 ]
  PRO-2 remission is defined based on average daily stool frequency (SF), average daily abdominal pain (AP) score and no worsening of AP or SF from baseline.
• Phase 2: Clinical-Biomarker Response at Week 12 [ Time Frame: Week 12 ]
  Clinical-biomarker response is defined using clinical response based on the CDAI score and reduction from baseline in C-reactive protein (CRP) or fecal calprotectin.
• Phase 2: Endoscopic Response at Week 12 [ Time Frame: Week 12 ]
  Endoscopic Response is measured by the 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: Clinical Remission at Week 48 [ Time Frame: Week 48 ]
  Clinical remission is defined as CDAI score <150.
• Phase 3: Endoscopic Response at Week 48 [ Time Frame: Week 48 ]
  Endoscopic Response is measured by the 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: Durable Clinical Remission at Week 48 [ Time Frame: Week 48 ]
  Durable clinical remission is defined as CDAI<150 for most of all visits between Week 12 and Week 48.
• Phase 3: Corticosteroid-Free Clinical Remission at Week 48 [ Time Frame: Week 48 ]
  Corticosteroid-free clinical remission is defined as CDAI score <150 at Week 48 and not receiving corticosteroids at Week 48.
• Phase 3: PRO-2 Remission at Week 48 [ Time Frame: Week 48 ]
  PRO-2 remission is defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score.
• Phase 3: Endoscopic Remission at Week 12 [ Time Frame: Week 12 ]
  Endoscopic remission is defined as SES-CD score <=2.
• Phase 3: Endoscopic Remission at Week 48 [ Time Frame: Week 48 ]
  Endoscopic remission is defined as SES-CD score <=2.
• Phase 3: Fatigue Response at Week 12 [ Time Frame: Week 12 ]
  Fatigue response will be based on the Patient-Reported Outcomes Measurement Information System (PROMIS). Fatigue Short Form 7a contains 7 items that evaluate the severity of fatigue, with higher scores indicating greater fatigue.

Original Secondary Outcome Measures (submitted: March 8, 2018)

• Phase 2: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
  Clinical remission is defined as CDAI score <150.
• Phase 2: Clinical Response at Week 12 [ Time Frame: Week 12 ]
  Clinical response is defined as greater than or equal to (>=) 100-point reduction from baseline in CDAI score or CDAI score <150.
• Phase 2 and Phase 3: Patient-Reported Outcome (PRO)-2 Remission at Week 12 [ Time Frame: Week 12 ]
  PRO-2 remission is defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score.
• Phase 2: Clinical-Biomarker Response at Week 12 [ Time Frame: Week 12 ]
  Clinical-biomarker response is defined using clinical response based on the CDAI score and reduction from baseline in C-reactive protein (CRP) or fecal calprotectin.
• Phase 2 and Phase 3: Endoscopic Response at Week 12 [ Time Frame: Week 12 ]
  Endoscopic Response is 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: Clinical Remission at Week 48 [ Time Frame: Week 48 ]
  Clinical remission is defined as CDAI score <150.
• Phase 3: Durable Clinical Remission at Week 48 [ Time Frame: Week 48 ]
  Durable clinical remission is defined as CDAI<150 for most of all visits between Week 12 and Week 48.
• Phase 3: Corticosteroid-Free Clinical Remission at Week 48 [ Time Frame: Week 48 ]
  Corticosteroid-free clinical remission is defined as CDAI score <150 at Week 48 and not receiving corticosteroids at Week 48.
• Phase 3: PRO-2 Remission at Week 48 [ Time Frame: Week 48 ]
  PRO-2 remission is defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score.
• Phase 3: Fatigue Response at Week 12 [ Time Frame: Week 12 ]
  Fatigue response will be based on the Patient-Reported Outcomes Measurement Information System (PROMIS). Fatigue Short Form 7a contains 7 items that evaluate the severity of fatigue, with higher scores indicating greater fatigue.
• Phase 3: Endoscopic Response at Week 48 [ Time Frame: Week 48 ]
  Endoscopic response is measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
• Official 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
• Brief Summary: 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.
• Detailed 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.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Crohn's Disease

Intervention

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

Study 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.
  Interventions:

  • Drug: Guselkumab Dose 1
  • Drug: Guselkumab Dose 2
• 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.
  Interventions:

  • Drug: Guselkumab Dose 2
  • Drug: Guselkumab Dose 3
• 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.
  Interventions:

  • Drug: Guselkumab Dose 4
  • Drug: Guselkumab Dose 5
• 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.
  Intervention: Drug: 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.
  Interventions:

  • Drug: Ustekinumab
  • Drug: Placebo
• 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.
  Intervention: Drug: 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.
  Intervention: Drug: 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.
  Interventions:

  • Drug: Ustekinumab
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 8, 2018): 2000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 25, 2026
• Estimated Primary Completion Date: June 3, 2022 (Final data collection date for primary outcome measure)

Eligibility 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
• Prior exposure to p40 inhibitors or p19 inhibitors
• Any medical contraindications preventing study participation

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Study Contact; 844-434-4210; JNJ.CT@sylogent.com

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

Administrative Information

• NCT Number: NCT03466411
• Other Study ID Numbers: CR108387; 2017-002195-13 ( EudraCT Number ); CNTO1959CRD3001 ( Other Identifier: Janssen Research & Development, LLC )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Janssen Research & Development, LLC
• Study Sponsor: Janssen Research & Development, LLC
• Collaborators: Not Provided

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

• PRS Account: Janssen Research & Development, LLC
• Verification Date: February 2021