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

NCT06910358 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2026-05-07

No results posted yet for this study

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

DRUG

Placebo

Oral dose, once a day for 24 weeks

DRUG

DISC-1459

Oral dose, once a day for 24 weeks

Sponsors & Collaborators

  • Disc Medicine, Inc

    lead INDUSTRY

Principal Investigators

  • Will Savage, MD, PhD · Disc Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-04
Primary Completion
2026-09-30
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06910358 on ClinicalTrials.gov