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

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520407-27-00

Acronym

DISC-1459-301

Enrollment

Registered

2025-09-29

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

Average monthly total time in sunlight on days without pain from a phototoxic reaction between 10:00 to 18:00 (10:00 AM to 6:00 PM) after 6 months (24 weeks) of treatment, Percent change from baseline in whole-blood metal-free PPIX levels at 6 months, Safety and tolerability, as assessed by adverse events (AEs) and laboratory results, over the 6-month treatment period

Detailed description

Occurrence of phototoxic reactions over the 6-month treatment period, Cumulative total time in sunlight on days without pain from a phototoxic reaction between 10:00 to 18:00 (10:00 AM to 6:00 PM) over the 6-month (24-week) treatment period, Change from baseline in 2-week average daily sunlight exposure time (minutes) to first prodromal symptom (eg, burning, tingling, itching, or stinging) associated with sunlight exposure between 1 hour post-sunrise and 1 hour pre-sunset at 6 months

Interventions

DRUGBitopertin

DRUGMatching Placebo

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Occurrence of phototoxic reactions over the 6-month treatment period, Cumulative total time in sunlight on days without pain from a phototoxic reaction between 10:00 to 18:00 (10:00 AM to 6:00 PM) over the 6-month (24-week) treatment period, Change from baseline in 2-week average daily sunlight exposure time (minutes) to first prodromal symptom (eg, burning, tingling, itching, or stinging) associated with sunlight exposure between 1 hour post-sunrise and 1 hour pre-sunset at 6 months	—

Measure

Time frame

—

Primary

Measure	Time frame
Average monthly total time in sunlight on days without pain from a phototoxic reaction between 10:00 to 18:00 (10:00 AM to 6:00 PM) after 6 months (24 weeks) of treatment, Percent change from baseline in whole-blood metal-free PPIX levels at 6 months, Safety and tolerability, as assessed by adverse events (AEs) and laboratory results, over the 6-month treatment period	—

Countries

Belgium, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026