WHO ICTRP trial
FT011 for Scleroderma
EUCTR2020-005116-21-PL · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2020-005116-21-PL |
|---|---|
| Public title | FT011 for Scleroderma |
| Scientific title | A phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, of oral FT011 in participants with diffuse systemic sclerosis - FT011 for scleroderma |
| Primary sponsor | Certa Therapeutics Pty Ltd |
| 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 | Spain;Poland;Ukraine;Australia;Russian Federation;Netherlands |
| Conditions | diffuse systemic sclerosis MedDRA version: 21.0 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12] |
| Interventions | Product Name: FT011 100 mg Product Code: FT011 Pharmaceutical Form: Capsule INN or Proposed INN: None yet CAS Number: 1001288-58-9 Current Sponsor code: FT011 Other descriptive name… |
| Registration date | Jun 25, 2021 |
| Target size | 30 |
| Secondary IDs | CER-FT011-SSc01;NCT04647890 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: