A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: JNJ-67864238; Placebo
Intervention description: Participants will receive oral tablets of JNJ-67864238 twice daily.; Participants will receive oral tablets of matching placebo twice daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of JNJ-active as measured by the change
      in the Crohn's Disease Activity Index (CDAI) score and Simplified Endoscopic Score for
      Crohn's disease (SES-CD) from baseline at Week 12.
    

Eligibility 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