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

Purpose of this study?

The purpose of the 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.

Inclusion Criteria:

•      ≥18 years of age at screening

• 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

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.

   3.  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.

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), average daily 

        abdominal pain (AP) score and no worsening of AP or SF from baseline.

  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: 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.

 6.  Phase 3: Clinical Remission at Week 48 [ Time Frame: Week 48 ]

       Clinical remission is defined as CDAI score <150.

 7.  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.

 8.  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.

 9.  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.

 10.  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.

 11.  Phase 3: Endoscopic Remission at Week 12 [ Time Frame: Week 12 ]

          Endoscopic remission is defined as SES-CD score <=2.

 12.  Phase 3: Endoscopic Remission at Week 48 [ Time Frame: Week 48 ]

          Endoscopic remission is defined as SES-CD score <=2.

 13.  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.

Study Locations in Europe:

Austria, Belarus, Belgium, Bosnia-Herzegovina, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Russian Federation, Serbia, Slovakia, Spain, Ukraine, United Kingdom

Estimated Study Completion Date: December 31, 2024

Further information on clinicaltrial.gov with trial number NCT03466411