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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 : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Guselkumab Dose 1 Drug: Guselkumab Dose 2 Drug: Guselkumab Dose 3 Drug: Guselkumab Dose 4 Drug: Guselkumab Dose 5 Drug: Guselkumab Drug: Ustekinumab Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : June 3, 2022
Estimated Study Completion Date : October 23, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Guselkumab

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. Phase 3: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission is defined as CDAI score less than (<) 150 points.


Secondary Outcome Measures :
  1. Phase 2: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission is defined as CDAI score <150.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Phase 3: Clinical Remission at Week 48 [ Time Frame: Week 48 ]
    Clinical remission is defined as CDAI score <150.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466411


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

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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03466411     History of Changes
Other Study ID Numbers: CR108387
2017-002195-13 ( EudraCT Number )
CNTO1959CRD3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

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

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Antibodies, Monoclonal
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs