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Effects of FT011 in Systemic Sclerosis

NCT04647890 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-20

Study results available
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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

  • Scleroderma, Systemic
  • Scleroderma, Diffuse
  • Sclerosis, Systemic

Interventions

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

Sponsors & Collaborators

  • Certa Therapeutics

    lead INDUSTRY

Principal Investigators

  • Darren Kelly, PhD · Certa Therapeutics Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2022-10-12
Completion
2022-11-16
FDA Drug
Yes

Countries

  • Australia
  • Netherlands
  • Poland
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04647890 on ClinicalTrials.gov