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Stelara (ustekinumab)
Ustekinumab is a monoclonal antibody that blocks the IL-12 and IL-23 cytokines, which are key drivers of inflammatory and autoimmune responses.
Ustekinumab is a monoclonal antibody that blocks the IL-12 and IL-23 cytokines, which are key drivers of inflammatory and autoimmune responses. Used for Plaque psoriasis, Psoriatic arthritis, Ankylosing spondylitis.
At a glance
| Generic name | Stelara (ustekinumab) |
|---|---|
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Drug class | IL-12/IL-23 inhibitor (monoclonal antibody) |
| Target | IL-12 p40 subunit / IL-23 p40 subunit |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Ustekinumab binds to the p40 subunit shared by IL-12 and IL-23, preventing these interleukins from activating T cells and other immune cells that drive inflammation. By inhibiting these pathways, it reduces pathogenic Th1 and Th17 cell differentiation and proliferation, thereby suppressing the inflammatory cascade underlying autoimmune and inflammatory diseases.
Approved indications
- Plaque psoriasis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
Common side effects
- Nasopharyngitis
- Upper respiratory tract infection
- Headache
- Fatigue
- Injection site reactions
- Increased infection risk
Key clinical trials
- Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
- A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
- A Long-term Extension Study of Ustekinumab in Pediatric Participants (PHASE3)
- A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease (PHASE4)
- Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
- A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) (PHASE4)
- A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (PHASE2, PHASE3)
- A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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