51. Scleroderma Clinical trials / Disease details
Clinical trials : 525 / Drugs : 565 - (DrugBank : 148) / Drug target genes : 114 - Drug target pathways : 217
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-002081-13-PL (EUCTR) | 09/12/2020 | 30/09/2020 | A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc). | A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in patients with systemic sclerosis (SSc) | Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc) MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866 MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GS-248 Product Code: GS-248 INN or Proposed INN: GS-248 | Gesynta Pharma AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Poland;Netherlands;United Kingdom | ||
| 2 | EUCTR2020-002081-13-NL (EUCTR) | 02/11/2020 | 17/08/2020 | A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc). | A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in subjects with systemic sclerosis (SSc) | Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc) MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866 MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GS-248 Product Code: GS-248 INN or Proposed INN: GS-248 | Gesynta Pharma AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Poland;Netherlands;United Kingdom | ||
| 3 | EUCTR2020-002081-13-GB (EUCTR) | 08/09/2020 | 21/07/2020 | A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc). | A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in patients with systemic sclerosis (SSc) | Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc) MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866 MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GS-248 Product Code: GS-248 INN or Proposed INN: GS-248 | Gesynta Pharma AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United Kingdom | ||
| 4 | NCT04036227 (ClinicalTrials.gov) | July 3, 2019 | 23/7/2019 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248 | A Phase I, Placebo-controlled, Double-blind, First-in-human Study to Investigate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-248 Solution in Healthy Subjects and Patients With Systemic Sclerosis (SSc) | Healthy | Drug: GS-248;Drug: Placebo | Gesynta Pharma AB | CTC Clinical Trial Consultants | Completed | 18 Years | 75 Years | All | 72 | Phase 1 | Sweden |