Moderately to Severely Active Crohn's Disease Crohn's Disease
Conditions
Interventions
Phase 2 Dose-Ranging Study (GALAXI 1)
All participants in the Phase 2 study will be randomized to 1 of 5 treatment groups as described below. Participants will remain on their
assigned treatment regi
Guselkumab will be administered by IV infusion.
Guselkumab will be administered by SC injection.
Guselkumab will be by SC injection.
Guselkumab will be administered by IV infusion and SC injection.
Ustekinumab will be administered by IV infusion and SC injection.
Placebo will be administered as IV infusion.
Phase 2 (GALAXI 1): Group 1 (Guselkumab)
Phase 2 (GALAXI 1): Group 1 (Guselkumab) Phase 2 (GAL AXI 1): Group 2 (Guselkumab)
Phase 2 (GALAXI 1): Group 2 (Guselkumab)
Phase 2 (GALAXI 1): Group 3 (Guselkumab)
Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)
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)
Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)
Sponsors
Janssen Research & Development, LLC
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: • =18 years of age at screening • CD or fistulizing CD of = 3 months duration (defined as = 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy • Clinically active CD, defined as a baseline CDAI score =220 but =450 and either: mean daily SF count >3 or mean daily AP score > 1 • Endoscopic evidence of active ileocolonic CD as assessed by central endoscopy reading at the screening endoscopy, defined as a screening SES-CD score = 6 (or = 4 for participants with isolated ileal disease), based on the presence of ulceration in = 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: – A minimum score of 1 for the component of “size of ulcers” and – A minimum score of 1 for the component of “ulcerated surface” • At least 1 of the following: – Current treatment with oral corticosteroids and/or immunomodulators (AZA, 6-MP, MTX) or – History of failure to respond to or tolerate oral corticosteroids or immunomodulators (AZA, 6-MP, MTX) or – History of corticosteroid dependence or – Prior primary nonresponse, secondary nonresponse, or intolerance to 1 or more biologic agent with at least the minimum dose approved for the treatment of CD (ie, infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents) – A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might confound ability to assess the effect of treatment - Current or suspected abscess, unless adequately treated = 3 weeks before baseline - Any kind of bowel resection within 6 months, or any other intra-abdominal or other major surgery within 12 weeks before baseline - Draining (ie, functioning) stoma or ostomy - Positive for an enteric pathogen, including Clostridioides difficile toxin in the previous 4 months - Any of the following prescribed medications or therapies within the specified period: – IV corticosteroids within 3 weeks of baseline – Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks of baseline – 6-thioguanine within 4 weeks of baseline – Biologic agents: anti-TNF therapy (eg, infliximab, etanercept, certolizumab pegol, adalimumab, golimumab) within 8 weeks of baseline; vedolizumab within 12 weeks of baseline; ustekinumab within 16 weeks of baseline; other immunomodulatory biologic agents, including approved and investigational biologic agents, within 12 weeks of baseline or within 5 half-lives of baseline, whichever is longer – Any investigational intervention within 4 weeks of baseline or within 5 half-lives of baseline, whichever is longer – Nonautologous stem cell therapy (eg, Prochymal), natalizumab, efalizumab, or biologic agents that deplete B- or T-cells (eg, rituximab, alemtuzumab, or visilizumab) received within 12 months of baseline – Treatment with apheresis (eg, Adacolumn apheresis) or total parenteral nutrition for Crohn’s disease within 3 weeks of baseline - Has previously received a biologic agent targeting IL-12/23 or IL-23, including but not limited to briakinumab, brazikumab, guselkumab, mirikizumab (formerly LY3074828), and risankizumab
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Name: Clinical remission is defined as CDAI score =) 100-point reduction from baseline in CDAI score or CDAI score <150.;Timepoints: Week 12;Measure: Phase 2: Clinical Response at Week 12;Name: PRO-2 remission is defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score.;Timepoints: Week 12;Measure: Phase 2 and Phase 3: Patient-Reported Outcome (PRO)-2 Remission at Week 12;Name: 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.;Timepoints: Week 12;Measure: Phase 2: Clinical-Biomarker Response at Week 12;Name: 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.;Timepoints: Week 12;Measure: Phase 2 and Phase 3: Endoscopic Response at Week 12;Name: Clinical remission is defined as CDAI score <150.;Timepoints: Week 48;Measure: Phase 3: Clinical Remission at Week 48;Name: Durable clinical remission is defined as CDAI<150 for most of all visits between Week 12 and Week 48.;Timepoints: Week 48;Measure: Phase 3: Durable Clinical Remission at Week 48;Name: Corticosteroid-free clinical remission is defined as CDAI score <150 at Week 48 and not receiving corticosteroids at Week 48.;Timepoints: Week 48;Measure: Phase 3: Corticosteroid-Free Clinical Remission at Week 48;Name: PRO-2 remission is defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score.;Timepoints: Week 48;Measure: Phase 3: PRO-2 Remission at Week 48;Name: 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.;Timepoints: Week 12;Measure: Phase 3: Fatigue Response at Week 12;Name | — |
Primary
| Measure | Time frame |
|---|---|
| Name: 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.;Timepoints: Baseline and Week 12;Measure: Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12;Name: Clinical remission is defined as CDAI less than (<) 150 points.;Timepoints: Week 12;Measure: Phase 3: Clinical Remission at Week 12 | — |
Countries
Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Colombia, Croatia, Czech Republic, France, Georgia, Germany, Hungary, India, Italy, Japan, Jordan, Latvia, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Poland, Portugal, Republic of Korea, Republic of Serbia, Russian Federation, Saudi Arabia, Slovakia, Spain, Taiwan, The Former Yugoslav Rep of Macedonia, Tunisia, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactAziz Zoghbi
MCT s.a.r.l (CRO)
Outcome results
None listed