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

Study acronym: APOLLO
StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Sep 2026 to Sep 8, 2026
    • Study completion date changed from estimate of Oct 2026 to Sep 8, 2026
    • Eligibility criteria expanded, about 7 words
    • Site details revised at 4 of 27 sites
  2. 10 versions Re-verified since May 5, 2026, no change to tracked fieldsv25-v34
  3. Trial status changed: Recruiting → Active, Not Recruitingv24 Show 4 more changesShow less
    • Enrollment increased: 150 → 183 participants
    • Primary completion moved earlier from Oct 2026 to Sep 2026
    • Study completion moved earlier from Nov 2026 to Oct 2026
    • Study sites: 28 to 27
  4. Study sites: 23 to 28v23
  5. Study sites: 22 to 23v22
Show 20 earlier versionsHide 20 earlier versions
  1. Study sites: 20 to 22v21
  2. Study sites: 19 to 20v20
  3. Study sites: 16 to 19v19
  4. Study sites: 15 to 16v18
  5. Site details revised at 1 of 15 sitesv17
  6. Study sites revised (15)v16
  7. Study sites: 12 to 15v15
  8. Study sites: 11 to 12v14
  9. Study sites: 9 to 11v13
  10. Study sites: 8 to 9v12
  11. Study sites: 7 to 8v11
  12. Site details revised at 1 of 7 sitesv10
  13. Site details revised at 1 of 7 sitesv9
  14. Study sites: 5 to 7v8
  15. Study sites: 4 to 5v7
  16. Start date changed from estimate of Apr 2025 to Apr 4, 2025v6
  17. Site details revised at 4 of 4 sitesv5
  18. Site contacts updated at 1 of 4 sitesv4
  19. Study sites: 2 to 4v3
  20. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06910358
Lead Sponsor Disc Medicine, Inc
Conditions
(from sponsor)		 Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP)
Related terms Porphyrias, Protoporphyria, Erythropoietic, Protoporphyria, Erythropoietic, X-Linked Dominant
Enrollment 183 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov