A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallelgroup, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
- 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
- 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 (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 8 weeks prior to baseline (or within 5 half-lives of baseline, whichever is longer)
- Prior exposure to p40 inhibitors or p19 inhibitors
- Any medical contraindications preventing study participation
18age old over
No limit
Both
Crohn's Disease
investigational material(s)
Generic name etc : Guselkumab
INN of investigational material : Guselkumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Phase 2 (GALAXI 1): Group 1 (Guselkumab) Guselkumab will be administered by IV infusion. Phase 2 (GALAXI 1): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by SC injection. Phase 2 (GALAXI 1): Group 2 (Guselkumab) Guselkumab will be administered by IV infusion. Phase 2 (GALAXI 1): Group 3 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection. Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection
control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5(Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV infusion.
Generic name etc : Ustekinumab
INN of investigational material : Ustekinumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5(Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV infusion.
efficacy
Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
efficacy
Phase 3: Clinical Response at Week 12 and Clinical Remission at Week 48
efficacy
Phase 3: Clinical Response at Week 12 and Endoscopic Response at Week48
efficacy
Phase 2: Clinical Remission at Week 12 Clinical remission is defined as CDAI score <150
efficacy
Phase 2: Clinical Response at Week 12 Clinical response is defined as greater than or equal to (>=) 100-point reduction from baseline in CDAI score or CDAI score <150
efficacy
Phase 2 and Phase 3: Patient-Reported Outcome (PRO)-2 Remission at Week 12 PRO-2 remission is defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score and no worsening of AP or SF from baseline.
efficacy
Phase 2: Clinical-Biomarker Response at 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.
efficacy
Phase 2: Endoscopic Response at 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.
efficacy
Phase 3: Clinical Response at Week 4 Clinical response based on CDAI score.
efficacy
Phase 3: Clinical Remission at Week 12 Clinical remission based on CDAI score.
efficacy
Phase 3: Endoscopic Response at Week 12 Endoscopic response based on SES-CD score.
efficacy
Phase 3: Fatigue Response at Week 12 Fatigue response will be based on the
Patient-Reported Outcomes Measurement
Information System (PROMIS).
efficacy
Phase 3: Clinical Remission at Week 12 and
Endoscopic Response at Week 12
Clinical remission based on CDAI score and
endoscopic response based on SES-CD
score.
efficacy
Phase 3: Endoscopic Remission at Week 12
Endoscopic remission based on SES-CD score.
efficacy
Phase 3: Clinical Response at Week 12 and
Corticosteroid-Free Clinical Remission at
Week 48
Clinical response based on CDAI score;
corticosteroid-free clinical remission based on CDAI score and corticosteroid concomitant medications.
efficacy
Phase 3:Clinical Response at Week 12 and Endoscopic Remission at Week 48 Clinical response based on CDAI and
endoscopic remission based on SES-CD.
efficacy
Phase 3: Clinical Remission at Week 48 Clinical remission based on CDAI score.
efficacy
Phase 3: Endoscopic Response at Week 48 Endoscopic response based on SES-CD.
efficacy
Phase 3: Clinical Remission at Week 48 and
Endoscopic Response at Week 48
Clinical remission based on CDAI score and endoscopic response based on SES-CD score.
efficacy
Phase 3: Endoscopic Remission at Week 48
Endoscopic remission based on SES-CD score.
efficacy
Phase 3: Deep Remission at Week 48
Deep remission is defined as clinical
remission and endoscopic remission.
