Phase 3
N=598
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT04785326 ↗Enrolled (actual)
598
Serious AEs
0.9%
Results posted
Jan 2024
Primary outcome: Primary: • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara — 77.5; 77.85; 87.59; 87.89 percent change in PASI score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DMB-3115 (Drug); Stelara (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dong-A ST Co., Ltd.
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara |
77.5; 77.85; 87.59; 87.89 | — |
Summary
This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.
Eligibility Criteria
Inclusion Criteria
- Patients who have a diagnosis of plaque-type psoriasis for at least 6 months.
Exclusion Criteria
- Patients with hypersensitivity to ustekinumab or any of the product excipients.
Data sourced from ClinicalTrials.gov (NCT04785326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.