KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
What is the purpose of this trial?
Phase II Diffuse Cutaneous Systemic Sclerosis study seeking to evaluate the efficacy and safety of KD025. Upon eligibility confirmation, a total of sixty (60) adult subjects will be enrolled and randomized into three (3) groups (1:1:1) to either receive orally administered KD025 (two doses) or matched placebo for 28 weeks. The study will be double-blinded for the first 28 weeks followed by an open label extension period of 24 weeks. After un-blinding, the subjects on KD025 will continue on the same KD025 dose whereas the subjects in the placebo group will be re-randomized to one of the KD025 doses.
- Ages18 years - 100 years
- Trial withKadmon Corporation, LLC
- Start Date12/16/2019
- End Date12/31/2021
- Last Updated07/15/2021
- Study HIC#2000026048