Phase 3
Completed N=509
A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
Source: ClinicalTrials.gov NCT04673786 ↗Enrolled (actual)
509
Serious AEs
1.8%
Results posted
Jun 2023
Primary outcomePrimary: The Mean Percent Improvement From Baseline in PASI Score at Week 12 — 77.93; 75.89 percentage of improvement in PASI score
◆ Published Evidence
Established
26citations · ~13 / year
Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study.
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.
Linked Publications
-
Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Percent Improvement From Baseline in PASI Score at Week 12 |
77.93; 75.89 | — |
| SECONDARY The PASI Scores at Week 12 |
2.98; 3.44 | — |
| SECONDARY The Mean Percent Improvement From Baseline in PASI Score Through Week 52 |
93.79; 93.39; 91.58 | — |
| SECONDARY The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12 |
247; 240; 212; 187; 129; 127 | — |
| SECONDARY The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12 |
219; 201 | — |
| SECONDARY The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52 |
-10.5; -8.5; -9.2 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has had diagnosis of plaque-type psoriasis for at least 24 weeks.
Exclusion Criteria
- Patients diagnosed with forms of psoriasis other than plaque-type.
- Patients previously received ustekinumab or a biosimilar of ustekinumab.
- Patient who has allergies to the active substance or any of the excipients of ustekinumab or study drug, or patients with a hypersensitivity to immunoglobulin products or natural rubber and latex.
Data sourced from ClinicalTrials.gov (NCT04673786) and the linked publication. 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. Informational only — not medical advice.