Clinical Trial

Study of Bitopertin in Participants With EPP or XLP (APOLLO)

Study acronym: APOLLO
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if bitopertin works and is safe to treat EPP or XLP in participants 12 years or older. The main questions it aims to answer are: * Whether bitopertin increases pain-free sunlight exposure after 6 months of treatment in participants with EPP or XLP. * How PPIX concentration levels change from before bitopertin treatment to after 6 months of treatment. Researchers will compare bitopertin to a placebo look-alike substance that contains no drug. Participants will complete daily questionnaires and attend study visits for assessments.
Protocol Amendment History 4 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-14
notable Enrollment increased: 150 -> 183 participants 2026-04-14
notable Primary completion moved earlier: 2026-10 -> 2026-09 2026-04-14
minor Completion moved earlier: 2026-11 -> 2026-10 2026-04-14
Trial Details
NCT Number NCT06910358
Lead Sponsor Disc Medicine, Inc
Conditions Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP)
Enrollment 183 participants
Start Date 2025-04-04
Primary Completion 2026-09 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-12