WHO ICTRP trial
Immunotherapy with the bioactive substance Guselkumab in patients suffering from…
EUCTR2021-000271-36-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-000271-36-DE |
|---|---|
| Public title | Immunotherapy with the bioactive substance Guselkumab in patients suffering from oral skin disease Lichen-Planus using an open-label, parallel, multi-center phase IIa trial design |
| Scientific title | Guselkumab in Patients with Oral Lichen Planus - An open label, parallel, randomized, multi- center, phase II trial |
| Primary sponsor | Philipps University Marburg |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Germany |
| Conditions | severe oral lichen planus (LP) with variable phenotype (erosive, ulcerating, hyperplastic/leucoplastic, and combined forms) MedDRA version: 20.1 Level: PT Classification code 10030983 Term: Oral lichen planus System Organ Class: 10017947… |
| Interventions | Trade Name: Tremfya Product Name: Guselkumab Pharmaceutical Form: Solution for infusion in pre-filled syringe |
| Registration date | Jun 15, 2021 |
| Target size | 45 |
| Secondary IDs | KKS288 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: