WHO ICTRP trial
SB17 versus to Stelara® in Subjects with Moderate to Severe Plaque Psoriasis
EUCTR2020-006115-19-CZ · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2020-006115-19-CZ |
|---|---|
| Public title | SB17 versus to Stelara® in Subjects with Moderate to Severe Plaque Psoriasis |
| Scientific title | A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SB17 (proposed ustekinumab biosimilar) Compared to Stelara® in Subjects with Moderate to Severe Plaque Psoriasis |
| Primary sponsor | Samsung Bioepis Co., Ltd |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Czechia;Hungary;Estonia;Czech Republic;Poland;Ukraine;Lithuania;Latvia;Korea, Republic of |
| Conditions | Moderate to severe plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| Interventions | Product Name: SB17 (proposed ustekinumab biosimilar) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Other descriptive name: Ustekinumab Concentration unit: mg/ml… |
| Registration date | Mar 31, 2021 |
| Target size | 464 |
| Secondary IDs | SB17-3001;2020-006115-19-LV |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: