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Protocol JNJ-64304500
Title A Phase 2b Randomized, Double-Blind, PLACEBO-Controlled, Parallel-Group, Evaluating the Safety and Efficacy of JNJ-64304500 in Subjects with Moderate to Severely Active CD
Phase 2b
Area GI
Indication Moderate to Severely Active Crohn's Disease
Treatment JNJ-64304500 (formerly known as NNC0142-002) is a human immunoglobulin G4 isotype monoclonal antibody that binds specifically to the natural killer group 2 member D (NKG2D) receptor and blocks NKG2D ligand binding, thereby preventing the downstream-signaling events that otherwise lead to cell proliferation and release of proinflammatory cytokines and cytotoxic mediators
Requirement The subject population consists of men or women 18 years of age with moderate to severely active Crohns disease (of at least 3 months duration) and/or calprotectin >250mg/kg. Subjects must have colitis, ileitis, or ileocolitis previously confirmed at any time in the past by radiography, histology, and/or endoscopy. Subjects also must have previously failed or been intolerant to 1 or more approved biologic agents (ie: tumor necrosis factor alpha [TNF] antagonists or vedolizumab; Bio-IR subjects) or have demonstrated an inadequate response to or failed to tolerate corticosteroids or immunomodulators (ie: 6-mercaptopurine [6-MP], azathioprine[AZA], and methotrexate [MTX]) but not a biologic (Bio-NF subjects). *Study allows patients with fistulizing disease. Study duration is 24 weeks with subjects randomized in a 1:1 fashion
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