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NCT06910358 · ClinicalTrials.gov registry record · Phase 3
Study of Bitopertin in Participants With EPP or XLP (APOLLO)
A Phase 3 study of Erythropoietic Protoporphyria (EPP) and X-Linked Protoporphyria (XLP), sponsored by Disc Medicine.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT06910358 is a Phase 3 study of Erythropoietic Protoporphyria (EPP) and X-Linked Protoporphyria (XLP) that is actively recruiting participants, run by Disc Medicine. The registered enrollment target is 150 participants. The trial reports 20 study locations across 16 states.
The verdict
NCT06910358, a Phase 3 study of Erythropoietic Protoporphyria (EPP) and X-Linked Protoporphyria (XLP), is actively recruiting participants, sponsored by Disc Medicine.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. 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 9 total studies on file at ClinicalTrials.gov.
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.
NCT06910358 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Massachusetts, Other.
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).
What interventions are being tested in trial NCT06910358?
The interventions under investigation include: Placebo (DRUG), DISC-1459 (DRUG).
Who is sponsoring clinical trial NCT06910358?
This trial is sponsored by Disc Medicine, which has 9 total clinical trials registered on ClinicalTrials.gov.
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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