HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP

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NCT05883748 · readout ≤ 681 d

Sponsored by Disc Medicine, Inc (industry) · IRON — their whole pipeline →.

Phase

Phase 2/3

Status

Enrolling by invitation

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

230estimated

Sites

Countries

Australia, Belgium, France +5

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

2023-08-31

actual

When the study began enrolling

Primary completion

Jun 2028

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Jun 2028

estimated

The whole study's end, after follow-up

First posted

2023-06-01

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

Condition

Erythropoietic Protoporphyria

Interventions

Drug: DISC-1459 — also filed as Bitopertin, RO4917838
Drug: DISC-1459 — also filed as Bitopertin, RO4917838

Primary outcomes

what the primary-completion date above is the date OF

Incidence of treatment-emergent adverse events

measured up to 5 Years

Incidence of clinically abnormal vital signs

measured up to 5 Years

Incidence of clinically abnormal physical exam

measured up to 5 Years

Incidence of abnormal laboratory test results

measured up to 5 Years

Assessment of Patient Health Questionnaire (PHQ-8)

measured up to 5 Years

Assessment of C-SSRS

measured up to 5 Years

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