Moderately to severely active Crohn's Disease Digestive System
Conditions
Interventions
Experimental: Guselkumab
Participants will receive guselkumab induction dose subcutaneously (SC) at Weeks 0, 4, and 8 followed by guselkumab maintenance dose SC once every 4 weeks (q4w) from Week 12 t
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks’ duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy 2. Have moderately to severely active CD, defined as baseline Crohn’s Disease Activity Index (CDAI) score greater than or equal to (>=) 220 but less than or equal to (= 4 (for participants with isolated ileal disease) or >= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: a. A minimum score of 1 for the component of “size of ulcers” AND b. A minimum score of 1 for the component of “ulcerated surface" 4. In the opinion of the investigator, participant’s disease is appropriate to treat with the maintenance dosing regimens utilized in the study 5. Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol
Exclusion criteria
Exclusion criteria: 1. Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab 2. Currently has or is suspected to have an abscess 3. Has an active fistula during screening or at Week 0 with an anticipated need for surgery 4. Has had any kind of bowel resection within 24 weeks, or any other intraabdominal or other major surgery within 12 weeks, before first dose of study intervention 5. Currently has a malignancy or has a history of malignancy within 5 years before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Deep Remission at Week 52 Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as Crohn’s Disease Activity Index (CDAI) score less than () 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Composite Endpoint of Number of Participants with Clinical Remission and Endoscopic Response at Week 52 Clinical remission is defined as CDAI score 50 percent (%) improvement from baseline in the SES CD or SES-CD score 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease. [Time Frame: At Week 52] 3. Number of Participants with Clinical Remission at Week 52 Clinical remission is defined as CDAI score < 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity. [Time Frame: At Week 52] 4. Number of Participants with Steroid-Free Clinical Remission at Week 52 Steroid-free clinical remission is defined as clinical remission at Week 52 and not receiving corticosteroids for at least 90 days prior to Week 52. Clinical remission is defined as CDAI score < 150-point. [Time Frame: At Week 52] 5. Number of Participants with Abnormalities in Laboratory Parameters Number of participants with abnormalities in laboratory parameters (hematology and chemistry) will be reported. [Time Frame: Up to Week 148] 6. Number of Participants With Change From Baseline in Laboratory Abnormalities Number of participants with change from baseline in laboratory abnormalities (hematology and chemistry) will be reported. [Time Frame: Up to week 148] 7. Number of Participants with Adverse Events (AEs), Serious AEs and AEs Leading to Discontinuation of Study Intervention An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical | — |
Countries
Austria, Belgium, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Slovakia, Spain, Sweden, United Kingdom
Contacts
Public ContactBesarte Vrellaku
Outcome results
None listed