Stelara

Drug

Drug Profile

Stelara is the brand name for ustekinumab, a human interleukin-12 and interleukin-23 antagonist used in plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The label includes adult and pediatric indications depending on disease area. U.S. initial approval was in 2009, with recent indication updates in 2026.

Drug Class
Human interleukin-12 and interleukin-23 antagonist monoclonal antibody
Approval Status
FDA approved (Initial U.S. Approval: 2009; major indication update April 2026)
Mechanism of Action
Therapeutic activity is based on antagonism of IL-12 and IL-23 pathways.
Brand Names
  • STELARA
Indications
  • \Moderate to severe plaque psoriasis in adults and pediatric patients 6 years and older who are candidates for phototherapy or systemic therapy\
  • \Active psoriatic arthritis in adults and pediatric patients 6 years and older\
  • \Moderately to severely active Crohn's disease in adults and pediatric patients 2 years and older\
  • \Moderately to severely active ulcerative colitis in adults\

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Related Clinical Trials

NCT ID Title Status Phase
NCT05890118

Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule

COMPLETED PHASE1
NCT05335356

Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis

COMPLETED PHASE3
NCT04930042

Efficacy, Safety, and Immunogenicity of AVT04 With Moderate-to-Severe Chronic Plaque Psoriasis

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NCT04785326

Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis

COMPLETED PHASE3
NCT04673786

A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis

COMPLETED PHASE3
NCT03651518

Personalized Therapies in Inflammatory Complex Disease

COMPLETED PHASE2