WHO ICTRP trial
A Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients…
EUCTR2018-001238-16-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2018-001238-16-DE |
|---|---|
| Public title | A Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients with Moderate-to-Severe Plaque-Type Psoriasis |
| Scientific title | A Phase 3b, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients with Moderate-to-Severe Plaque-Type Psoriasis - GUIDE |
| Primary sponsor | Janssen-Cilag International NV |
| 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): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | France;Germany |
| Conditions | Moderate to Severe Plaque Type Psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Immune System… |
| Interventions | Product Name: Guselkumab Product Code: CNTO1959 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Guselkumab Current Sponsor code: CNTO1959 Other descriptive name: GUSELKUMAB Concentration unit: mg/ml… |
| Registration date | Sep 14, 2018 |
| Target size | 888 |
| Secondary IDs | CNTO1959PSO3012 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: