Purpose

The purpose of this program is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

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

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37212-1610

More Details

NCT ID
NCT03466411
Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.