NCT05308472Phase 2Completed

Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP

Study sponsor: Disc Medicine, Inc · IRON

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-02-20Actual

Enrollment · participants75Actual

Source updated2026-01-08Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-10-31 · 1 field changed

Primary outcomes · main study measures

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− Previous value

measure: Percent change from baseline in whole blood metal-free PPIX levels

+ Updated value

measure: Percent Change From Baseline in Whole Blood Metal-free PPIX Levels

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Study details

Conditions studied

Erythropoietic Protoporphyria

Treatments or interventions studied

DISC-1459DrugAlso known as Bitopertin, RO4917838
DISC-1459DrugAlso known as Bitopertin, RO4917838
PlaceboDrug

Primary outcomes · main study measures

measure: Percent Change From Baseline in Whole Blood Metal-free PPIX Levels; description: Percent change from baseline in PPIX concentration was analyzed using a mixed model repeated measures analysis in the ITT population.; timeFrame: 121 days

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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