Study of Bitopertin in Participants With EPP or XLP (APOLLO)
← catalyst calendarNCT06910358 · readout ≤ 42 d
Sponsored by Disc Medicine, Inc (industry) · IRON — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
183actual
Sites
27
Countries
Australia, Belgium, Canada +9
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-04-04 | actual | When the study began enrolling |
| Primary completion | Sep 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2025-04-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Erythropoietic Protoporphyria (EPP)
- X-Linked Protoporphyria (XLP)
Interventions
- Drug: Placebo
- Drug: DISC-1459 — also filed as Bitopertin, RO4917838
Primary outcomes
what the primary-completion date above is the date OFAverage 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
measured 24 weeks
Percent change from baseline in whole-blood metal-free PPIX levels at 6 months
measured 24 weeks
Safety and tolerability, as assessed by adverse events (AEs) and laboratory results, over the 6-month treatment period
measured 24 weeks
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