Study of Bitopertin in Participants With EPP or XLP (APOLLO)
Public ClinicalTrials.gov record NCT06910358. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
APOLLO: A Randomized, Double-Blind, Placebo-Controlled Study of Bitopertin to Evaluate the Efficacy, Safety, and Tolerability in Participants With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06910358
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 183 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 4, 2025 (Actual)
- Primary completion
- Sep 8, 2026 (Actual)
- Completion
- Sep 8, 2026 (Actual)
- Last update posted
- Oct 9, 2026
2025 – 2026
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Marvel Clinical Research | Huntington Beach | California | 92647 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33146 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02115 | — |
| MetroBoston Clinical Partners | Boston | Massachusetts | 02135 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | — |
| Remington-Davis Clinical Research | Columbus | Ohio | 43215 | — |
| University of Texas Medical Branch | Galveston | Texas | 77550 | — |
| University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06910358, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 9, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06910358 live on ClinicalTrials.gov.