A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 8 November 2021
• Main ID: NCT04102111
• Date of registration: 23/09/2019
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease PRISM
• Scientific title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's Disease
• Date of first enrolment: September 23, 2019
• Target sample size: 90
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04102111
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, France, Germany, Italy, Poland, Russian Federation, Ukraine, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

• Name: Study Contact

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index
(CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450

- Have evidence of active ileocolonic Crohn's disease as assessed by an Simplified
Endoscopic Score for Crohn's disease (SES-CD) score >=3 at screening by central
endoscopy reading; or an elevated screening C-reactive protein (CRP) (greater than [>]
0.3 milligrams per deciliter [mg/dL] or 3.0 milligrams per liter [mg/L]) or an
elevated screening fecal calprotectin (>250 micrograms per mg [mcg/mg])

- A participant with a family history of colorectal cancer, personal history of
increased risk of colorectal cancer, age > 50 years, or other known risk factor must
be up-to-date on colorectal cancer surveillance (may be performed during screening).
Adenomatous polyps must be removed before the first administration of the study
intervention

- A woman of childbearing potential must have a negative highly sensitive serum
(Beta-human chorionic gonadotropin [beta-hCG]) pregnancy test result at screening and
a negative urine pregnancy test result at Week 0

- Has previously demonstrated inadequate response to, loss of response to, or
intolerance to an approved biologic therapy (unless otherwise specified in the
JNJ-67864238 intervention cohort specific criteria, that is, anti-tumor necrosis
factor (TNF) alpha agents (for example, infliximab, adalimumab, certolizumab pegol],
anti- interleukin (IL)-12/23 agents [for example, ustekinumab], or anti-integrin
agents [for example, vedolizumab]) or has previously demonstrated an inadequate
response to or failed to tolerate corticosteroids or immunomodulators (that is,
6-mercaptopurine [6-MP], azathioprine [AZA], and methotrexate [MTX]) but not a
biologic, that is, the biologic nonfailures (Bio-NF) population

- Therapy for the treatment of Crohn's disease must include at least 1 of the following
medications, which should have been maintained at stable doses prior to the baseline
(Week 0) visit: (a) Oral 5-aminosalicylic acid (5-ASA) compounds; (b) Oral
corticosteroids at a prednisone-equivalent dose <= 25 milligrams 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; and (d) Conventional immunomodulators
(that is, AZA, 6-MP, or MTX) if participants have been taking them for at least 12
weeks and have been at a stable dose for at least 4 weeks prior to baseline

Exclusion Criteria:

- Prior exposure to an anti-IL-12/23 (that is ustekinumab) or anti-IL-23 agents or
related compound (including risankizumab, brazikumab, guselkumab, mirikizumab, and
related compounds). Exception is made for participants who have had minimal exposure
to ustekinumab at its approved labeled dosage and have met the required wash-out
criteria and have not demonstrated inadequate response or intolerance to ustekinumab

- Known allergies, hypersensitivity, or intolerance to JNJ-67864238 or its excipients

- Has complications of Crohn's disease such as symptomatic strictures or stenoses, short
gut syndrome, or any other manifestation that might be anticipated to require surgery,
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 JNJ-67864238

- Has had any kind of bowel resection within 6 months or any other intra-abdominal
surgery within 3 months before baseline

- Initiation of total (complete) or partial (supplemental) parenteral nutrition
administered through any indwelling catheter less than (<) 3 weeks before baseline or
anticipated to require parenteral nutrition administered through an indwelling
catheter during enrollment in the study



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: JNJ-67864238

Drug: Placebo

Primary Outcome(s)

Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

Percentage of Participants with Clinical Remission at Week 12 [Time Frame: Week 12]

Percentage of Participants with Patient-reported Outcome (PRO)-2 Remission at Week 12 [Time Frame: Week 12]

Percentage of Participants with Endoscopic Response at Week 12 [Time Frame: Week 12]

Percentage of Participants with Clinical Response at Week 12 [Time Frame: Week 12]

Change From Baseline in Simplified Endoscopic Score for Crohn's disease (SES-CD) at Week 12 [Time Frame: Baseline and Week 12]

Percentage of Participants with Endoscopic Remission at Week 12 [Time Frame: Week 12]

Secondary ID(s)

2019-003335-37

67864238PACRD2001

CR108455

PLATFORMPACRD2001

2018-000649-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors