Trial reportAdvances in therapy2025
Pharmacokinetic Bioequivalence, Safety, and Immunogenicity of DMB-3115, an Ustekinumab Biosimilar, and EU- and US-Stelara in Healthy Adult Participants: A Randomized, Double-Blind, Single-Dose Study.
Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Association Between Efficacy and Pharmacokinetics of DMB-3115 and its Originator Ustekinumab in Patients with Chronic Plaque Psoriasis: An Exposure-Response Analysis.Advances in therapy · 2026Article
- Pharmacokinetics, Safety, and Immunogenicity of DMB-3115, a Ustekinumab Biosimilar for Immune-Mediated Diseases, in Healthy Japanese Male Participants: A Randomized, Double-Blind, Single-Dose Study.Advances in therapy · 2026Article
- Therapeutic drug monitoring with non-anti-TNF advanced therapies in inflammatory bowel disease: current and evolving paradigms.Frontiers in gastroenterology (Lausanne, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe aim of this study was to investigate the pharmacokinetic bioequivalence between DMB-3115 and ustekinumab (EU-Stelara or US-Stelara) as well as the safety and immunogenicity of these drugs in healthy adult participants.
methodsThis was a randomized, double-blind, three-arm parallel-group study. Healthy participants aged 18-55 years were randomly assigned in a 1:1:1 ratio to receive a single subcutaneous injection (45 mg) of either DMB-3115, EU-Stelara, or US-Stelara. Participants were stratified into two body weight groups (< 80 vs. ≥ 80 kg). Participants were followed for 16 weeks. The primary pharmacokinetic (PK) endpoints were area under the concentration-time curve from time zero to infinity (AUC
resultsA total of 296 participants (n = 99 in the DMB-3115 group, n = 99 in the EU-Stelara group, and n = 98 in the US-Stelara group) received the study drug and were included in the safety analysis. Of these, one participant in the DMB-3115 group had no valid PK data and was excluded from the PK analysis. The 95% confidence intervals (CI) for the ratios of geometric least squares means (DMB-3115/EU-Stelara and DMB-3115/US-Stelara) of the primary PK endpoints (AUC
conclusionDMB-3115 was bioequivalent to both reference ustekinumab in terms of pharmacokinetic profile and showed similar safety and immunogenicity profile after a single subcutaneous injection in parallel groups of healthy adult participants. CLINICAL
trial registrationEuropean Union Clinical Trials Register: number 2018-004033-33; date of registration 17 October 2018.
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