WHO ICTRP trial
A Phase 2, Multicenter, Randomised, Double-Blind…
EUCTR2020-000134-17-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2020-000134-17-DE |
|---|---|
| Public title | A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled-Parallel-Group study to determine how safe, effective and tolerable MT-7117 is in subjects with Diffuse Cutaneous Systemic Sclerosis |
| Scientific title | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis |
| Primary sponsor | Mitsubishi Tanabe Pharma Development America (MTDA), Inc. |
| 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 | United States;Canada;Poland;Spain;Belgium;Germany;United Kingdom;Italy |
| Conditions | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] |
| Interventions | Product Name: Dersimelagon Product Code: MT-7117 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Dersimelagon Current Sponsor code: MT-7117 Other descriptive name: MT-7117 Concentration unit: mg milligram(s) Concentration type… |
| Registration date | Jun 10, 2020 |
| Target size | 72 |
| Secondary IDs | MT-7117-G02;2020-000134-17-GB |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: