Summary of Clinical Use

Phase 1 clinical trials evaluating brazikumab as a monotherapy in mild to severe Crohn's disease (NCT01258205) and moderate to severe psoriasis (NCT01094093) have been completed. Phase 2 trials in subjects with active, moderate to severe Crohn's disease are ongoing (see NCT02574637 and NCT01714726).

Mechanism Of Action and Pharmacodynamic Effects

IL-23 is a potent inducer of pro-inflammatory cytokines including IL-6, IL-17, TNFα, IL-22 and GM-CSF. IL-23 is the key driver in autoimmune/inflammatory disease [1-2]. As such anti-IL-23 antibodies (targeting the p19 subunit unique to IL-23; IL23A) are being developed to ameliorate the effects of IL-23 related diseases or disorders. Such agents would be expected to inhibit IL-23 signaling, IL-23 activation of Th17 cells, IL-23 activation of NK cells, or production of proinflammatory cytokines.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT01094093	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis	Phase 1 Interventional	Allergan
NCT01258205	Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects	Phase 1 Interventional	Allergan
NCT01714726	Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.	Phase 2 Interventional	Allergan
NCT02574637	Evaluation of Efficacy and Safety of MEDI2070 in Subjects With Active, Moderate to Severe Crohn's Disease	Phase 2 Interventional	Allergan