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

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ClinicalTrials.gov Identifier: NCT03466411
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE March 8, 2018
First Posted Date  ICMJE March 15, 2018
Last Update Posted Date October 31, 2019
Actual Study Start Date  ICMJE April 13, 2018
Estimated Primary Completion Date June 3, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 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 score less than (<) 150 points.
Original Primary Outcome Measures  ICMJE
 (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.
Change History Complete list of historical versions of study NCT03466411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Official Title  ICMJE 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 program is to evaluate the efficacy 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2018)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 23, 2024
Estimated Primary Completion Date June 3, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Australia,   Austria,   Belarus,   Belgium,   Bosnia and Herzegovina,   Brazil,   Canada,   Chile,   China,   Colombia,   Croatia,   Czechia,   France,   Georgia,   Germany,   Greece,   Hungary,   India,   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 Ireland,   Macedonia, The Former Yugoslav Republic of,   Slovenia,   South Africa
 
Administrative Information
NCT Number  ICMJE NCT03466411
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP