NCT06910358

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

APOLLO: A Randomized, Double-Blind, Placebo-Controlled Study of Bitopertin to Evaluate the Efficacy, Safety, and Tolerability in Participants With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Disc Medicine, Inc · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erythropoietic Protoporphyria (EPP)
• X-Linked Protoporphyria (XLP)

Interventions

Type	Name	Description
DRUG	Placebo	Oral dose, once a day for 24 weeks
DRUG	DISC-1459	Oral dose, once a day for 24 weeks

Timeline

• Start date: 2025-04-04
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2025-04-04
• Last updated: 2026-04-13

Locations

27 sites across 12 countries: United States, Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study