Study of EPN-701 for Calciphylaxis
This study is testing a new oral medication called EPN-701 for people with calciphylaxis, a rare and painful skin condition. Currently, there isn't an approved treatment for calciphylaxis. This early study aims to see if EPN-701 is safe and effective in reducing pain and the size of skin lesions. You might receive EPN-701 or a placebo (a look-alike pill with no medicine). To join, you must be at least 18 years old, have a doctor's diagnosis of calciphylaxis with at least one skin ulcer, and provide your consent. The study plans to enroll 60 participants, but its current status is unclear.
- Study design
- This is a Phase 2, double-blind, randomized controlled trial. About 60 adult participants will be randomly assigned to receive either EPN-701 or a placebo for 24 weeks.
- What's involved
- You would take EPN-701 or a placebo orally once a day for 24 weeks. Your pain intensity and wound surface area will be measured at the beginning and at 24 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain intensity and wound surface area will be measured at 24 weeks, which is the end of the treatment period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of EPN-701 for the Treatment of Calciphylaxis
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Change in pain intensity (Alternate Primary Endpoint)Baseline-24 weeks
Pre-post (Baseline-Week 24) change in the worst calciphylaxis associated pain intensity as measured on the 0 to 10 scale among the trial arms. Score of 0 indicates no pain. Score of 10 indicates most severe pain
- Change in total calciphylaxis lesion(s) surface area (Alternate Primary Endpoint)Baseline-24 weeks
Pre-post (Baseline-Week 24) change in total surface area of ulcerated skin lesions of calciphylaxis among the trial arms