Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2024
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.
Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04673786 (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), which is not on this map. Cited by 11 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
11 citing papers in PubMed, 4 syntheses or guidelines pooled it, 22 citations in OpenAlex.
- Efficacy and Safety of Ustekinumab Biosimilars in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-analysis.Clinical drug investigation · 2026Pooled it
- Ustekinumab Biosimilars versus Reference Ustekinumab for Moderate-to-Severe Plaque Psoriasis: A Pre-switch Systematic Review and Meta-analysis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Pooled it
- Efficacy and safety of ustekinumab biosimilars for treating moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis.Naunyn-Schmiedeberg's archives of pharmacology · 2026Pooled it
- Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.The Cochrane database of systematic reviews · 2025Pooled it
- A Randomised, Double-Blind Trial to Compare the Efficacy, Safety, and Immunogenicity of the Biosimilar Ustekinumab FYB202 with Reference Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis.Advances in therapy · 2025Trial
- An Open-Label, Comparative, Parallel Clinical Trial of the Safety, Pharmacokinetics and Immunogenicity of the Ustekinumab Biosimilar GNR-068 and the Originally Developed Ustekinumab as a Reference Drug After a Single Subcutaneous Administration in Healthy Male Volunteers.Antibodies (Basel, Switzerland) · 2026Article
- Integration of Ustekinumab Biosimilars into Inflammatory Bowel Disease Care: Evidence, Implementation, and Patient-Centered Considerations.Advances in therapy · 2026Review
- Practical guidelines on medical management of adults with moderate-to-severe inflammatory bowel disease.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026Article
- A randomized, double-blind, phase 3 study to compare efficacy, safety, and immunogenicity between DMB-3115 and reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis.JAAD international · 2026Article
- Unlocking hope: The future of ustekinumab biosimilars in Crohn's disease treatment.United European gastroenterology journal · 2025Review
- Biosimilars for the Treatment of Moderate to Severe Chronic Plaque Psoriasis.Psoriasis (Auckland, N.Z.) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 11 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCT-P43 is a candidate ustekinumab biosimilar in clinical development.
objectivesThis paper aims to demonstrate equivalent efficacy of CT-P43 to originator ustekinumab in adults with moderate to severe plaque psoriasis.
methodsThis double-blind, phase III trial randomised patients (1:1) to receive subcutaneous CT-P43 or originator ustekinumab (45/90 mg for patients with baseline body weight ≤ 100 kg/> 100 kg) at week 0 and week 4 in Treatment Period I. Prior to week 16 dosing in Treatment Period II, patients receiving originator ustekinumab were re-randomised (1:1) to continue originator ustekinumab or switch to CT-P43; patients initially randomised to CT-P43 continued receiving CT-P43 (at weeks 16, 28 and 40). The primary endpoint of the trial was mean per cent improvement from baseline in Psoriasis Area Severity Index (PASI) score at week 12. Equivalence was concluded if confidence intervals (CIs) for the estimate of treatment difference were within pre-defined equivalence margins: ± 10% [90% CI; modified intent-to-treat set; Food and Drug Administration (FDA) approach] or ± 15% [95% CI; full analysis set for patients only receiving 45 mg doses in Treatment Period I; European Medicines Agency (EMA) approach]. Additional efficacy, pharmacokinetic, safety and immunogenicity endpoints were evaluated through week 52. Results to week 28 are reported here.
resultsIn Treatment Period I, 509 patients were randomised (CT-P43: N = 256; originator ustekinumab: N = 253). The mean per cent improvement in PASI score at week12 was 77.93% and 75.89% for CT-P43 and originator ustekinumab, respectively (FDA approach); per the EMA approach, corresponding values were 78.26% and 77.33%. Estimated treatment differences were 2.05 (90% CI -0.23, 4.32) and 0.94 (95% CI -2.29, 4.16); equivalence was achieved for both sets of assumptions. Further efficacy parameters and pharmacokinetic, safety and immunogenicity outcomes were comparable between treatment groups, including after switching from originator ustekinumab to CT-P43.
conclusionsCT-P43 demonstrated equivalent efficacy to originator ustekinumab in patients with moderate to severe plaque psoriasis, with comparable pharmacokinetic, safety and immunogenicity profiles. CLINICAL
trial registrationClinicalTrials.gov Identifier: NCT04673786; date of registration: 17 December, 2020.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.