Trials / Completed
CompletedNCT04673786
A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Moderate to Severe Plaque Psoriasis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 509 (actual)
- Sponsor
- Celltrion · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study is a randomized, active-controlled, double-blind, phase 3 study to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.
Detailed description
CT-P43, containing the active ingredient ustekinumab, is a human IgG1κ monoclonal antibody that is being developed as a biosimilar medicinal product to the reference product, Stelara. The purpose of this study is to demonstrate similar efficacy and safety of CT-P43 and Stelara in patients with moderate to severe plaque psoriasis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CT-P43 | 45mg or 90mg dose subcutaneous administration |
| BIOLOGICAL | Stelara | 45mg or 90mg dose subcutaneous administration |
Timeline
- Start date
- 2021-01-11
- Primary completion
- 2021-08-04
- Completion
- 2022-05-12
- First posted
- 2020-12-17
- Last updated
- 2023-06-05
- Results posted
- 2023-06-05
Locations
1 site across 1 country: Estonia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04673786. Inclusion in this directory is not an endorsement.