Phase 2
N=388
Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
Crohn Disease
Bottom Line
View on ClinicalTrials.gov: NCT02877134 ↗Enrolled (actual)
388
Serious AEs
7.9%
Results posted
Feb 2022
Primary outcome: Primary: Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8 — -60.0; -103.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JNJ-64304500 (Drug); Placebo (Drug); Ustekinumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8 |
-60.0; -103.6 | — |
| PRIMARY Part II: Change From Baseline in the CDAI Score at Week 12 |
-59.2; -93.2; -72.2; -84.3; -148.8 | — |
| SECONDARY Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150) |
14.6; 30; 18.4; 22.4; 53.2 | — |
| SECONDARY Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by CDAI (Greater Than or Equal to [>=] 100-point Reduction From Baseline in CDAI or CDAI <150) |
22.9; 42.0; 40.8; 30.6; 72.3 | — |
| SECONDARY Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12 |
-28.8; -46.1; -39.8; -42.9; -70.1 | — |
| SECONDARY Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75) |
16.7; 32.0; 30.6; 44.9; 53.2 | — |
| SECONDARY Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by PRO-2 (>=50-point Reduction From Baseline in PRO-2 Score or PRO-2 Score <75) |
31.3; 44.0; 46.9; 49.0; 68.1 | — |
| SECONDARY Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 |
-2.2; -0.7; -1.2; -2.7; -2.6 | — |
Summary
The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.
Eligibility 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
- Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (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 the first 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)
Data sourced from ClinicalTrials.gov (NCT02877134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.