Study of Bitopertin in Participants With EPP or XLP (APOLLO)
Condition(s) studied
Investigational drug(s) / intervention(s)
Placebo: Oral dose, once a day for 24 weeks
DISC-1459: Oral dose, once a day for 24 weeks
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.
Eligibility
Primary outcome measure(s)
- Average monthly total time in sunlight on days without pain from a phototoxic reaction between 10:00 to 18:00 (10:00 AM to 6:00 PM) after 6 months (24 weeks) of treatment — 24 weeks
- Percent change from baseline in whole-blood metal-free PPIX levels at 6 months — 24 weeks
- Safety and tolerability, as assessed by adverse events (AEs) and laboratory results, over the 6-month treatment period — 24 weeks
Trial sites (27)
| Facility | City | Region | Status |
|---|---|---|---|
| Marvel Clinical Research | Huntington Beach | California | |
| University of California San Francisco | San Francisco | California | |
| University of Miami Miller School of Medicine | Miami | Florida | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| MetroBoston Clinical Partners | Boston | Massachusetts | |
| Henry Ford Health System | Detroit | Michigan | |
| Mount Sinai Hospital | New York | New York | |
| Wake Forest University | Winston-Salem | North Carolina | |
| Remington-Davis Clinical Research | Columbus | Ohio | |
| University of Texas Medical Branch | Galveston | Texas | |
| University of Washington | Seattle | Washington | |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | |
| The Royal Melbourne Hospital | Parkville | Victoria | |
| UZ Leuven | Leuven | Belgium | |
| University of Alberta | Edmonton | Alberta | |
| CHU de Nantes - Hôtel Dieu, Service de dermatologie | Nantes | France | |
| Centre d'Investigation Clinique (CIC) Hôpital Bichat - Claude-Bernard | Paris | France | |
| Charité - Universitätsmedizin Berlin, Institute of Allergology | Berlin | Germany | |
| Klinikum Chemnitz gGmbH | Chemnitz | Saxony | |
| Children's Health Ireland (CHI) | Dublin | Ireland | |
| Instituto Dermatologico San Gallicano Istituti Fisioterapici Ospitalieri IRCCS | Roma | Italy | |
| Erasmus MC | Rotterdam | The Netherlands | |
| Hospital Clinic de Barcelona | Barcelona | Spain | |
| Karolinska University Hospital | Stockholm | Sweden | |
| Guy's and St Thomas' NHS Foundation Trust | London | England | |
| Clinical Research Centre, Ninewells Hospital & Medical School , NHS Tayside | Dundee | Scotland | |
| Photobiology Unit, Salford Royal Hospital | Salford | United Kingdom |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06910358 on ClinicalTrials.gov ↗ ← All trials in Italy