CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
FT011 +2 moredrug
Likely dose
FT011 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04647890
NCT04647890Phase 2Completed
CompareCT.gov

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

Certa Therapeutics·interventional·Posted Dec 1, 2020·Updated Dec 20, 2023

In Brief

A Phase 2 clinical trial evaluating FT011 and Placebo for Scleroderma, Systemic and 2 related conditions. Completed, enrolled 30 participants across 10 sites in 5 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScleroderma, Systemic, Scleroderma, Diffuse, Sclerosis, Systemic
CountriesAustralia, Netherlands, Poland, Spain, Ukraine
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 1, 2020
Enrollment StartJul 19, 2021
Primary CompletionOct 12, 2022
Study CompletionNov 16, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.6 years ago

Interventions

FT011drug

Two x 100mg capsules once daily for 12 weeks

FT011drug

Two x 200mg capsules once daily for 12 weeks

Placebodrug

Two placebo capsules once daily for 12 weeks