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.

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NCT07583745

Study of EPN-701 for the Treatment of Calciphylaxis

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Sagar U. Nigwekar, MD, MMSc
~60 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:EPN-701 (Oral)Placebo (Normal Saline)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pain intensity (Alternate Primary Endpoint)
Measured over Baseline-24 weeks
+1 more outcome measured
Calciphylaxis
1 sites across 1 states
Massachusetts1

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  • 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