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Study of Bitopertin in Participants With EPP or XLP (APOLLO)
NCT06910358 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Placebo
- DRUG DISC-1459
Study Locations (20)
California
- Marvel Clinical Research — Huntington Beach
- University of California San Francisco — San Francisco
Massachusetts
- Massachusetts General Hospital — Boston
- MetroBoston Clinical Partners — Boston
Other
- UZ Leuven — Leuven
- Children's Health Ireland (CHI) — Dublin
France
- CHU de Nantes - Hôtel Dieu, Service de dermatologie — Nantes
- Centre d'Investigation Clinique (CIC) Hôpital Bichat - Claude-Bernard — Paris
Florida
- University of Miami Miller School of Medicine — Miami
Michigan
- Henry Ford Health System — Detroit
New York
- Mount Sinai Hospital — New York
North Carolina
- Wake Forest University — Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-04-04 |
| Est. Completion | 2026-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06910358
The ClinicalTrials.gov registry entry for NCT06910358 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Disc Medicine, which has 60 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Erythropoietic Protoporphyria (EPP) appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06910358 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Massachusetts, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06910358 about?
NCT06910358 is a clinical study titled "Study of Bitopertin in Participants With EPP or XLP (APOLLO)". 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 ...
What is the current status of trial NCT06910358?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2025-04-04. Estimated completion is 2026-11.
What conditions does trial NCT06910358 study?
This clinical trial studies the following conditions: Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06910358?
The interventions under investigation include: Placebo (DRUG), DISC-1459 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06910358?
This trial is sponsored by Disc Medicine, which has 60 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06910358 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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