Trials / Completed
CompletedNCT04647890
Effects of FT011 in Systemic Sclerosis
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Certa Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This study is being conducted to see what the body does to the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FT011 | Two x 100mg capsules once daily for 12 weeks |
| DRUG | FT011 | Two x 200mg capsules once daily for 12 weeks |
| DRUG | Placebo | Two placebo capsules once daily for 12 weeks |
Timeline
- Start date
- 2021-07-19
- Primary completion
- 2022-10-12
- Completion
- 2022-11-16
- First posted
- 2020-12-01
- Last updated
- 2023-12-20
- Results posted
- 2023-12-20
Locations
10 sites across 5 countries: Australia, Netherlands, Poland, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04647890. Inclusion in this directory is not an endorsement.