KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
This randomized, placebo-controlled phase 2 study is seeking to evaluate the efficacy and
safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis.
Upon eligibility confirmation, a total of 60 adult subjects will be enrolled and randomized
into 3 groups (1:1:1) to either receive orally administered belumosudil (200 mg once daily
and 200 mg twice daily) or matched placebo for 28 weeks. Study drug dosing will be for 52
weeks: double-blinded for the first 28 weeks followed by an open-label extension of 24 weeks.
After unblinding, the subjects on belumosudil will continue on the same belumosudil dose
whereas the subjects in the placebo group will be re-randomized to one of the belumosudil
doses.