Crohn Disease
Conditions
Interventions
investigational material(s)
Generic name etc : Part I: JNJ-64304500
INN of investigational material : -
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration fo
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy - A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0 - Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5- aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c) Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline - A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy - Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 but <= 450
Exclusion criteria
Exclusion criteria: - Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factoralpha (TNF-alpha) antagonist biologic agents (example,monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before thefirst administration of study drug - Woman who is pregnant or planning pregnancy or is a man who plans to father while randomized in the study or within 16 weeks after the last administration of study agent - Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug - Participants with a history of or ongoing chronic or recurrent infectious disease - Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8 Baseline through Week 8 efficacy Part II: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 Baseline through Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Part II: Clinical Remission at Week 12 as Measured by Crohn's Disease Activity Index (CDAI =100-point reduction from baseline in CDAI or CDAI =50-point reduction from baseline in PRO-2 or PRO-2 <75) Week 12 efficacy Part II: Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) from baseline at Week 12 Baseline through Week 12 The SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 to 56). | — |
Countries
Asia except Japan, Europe, Japan, North America
Outcome results
None listed