NCT05883748

HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP

ENROLLING_BY_INVITATIONPHASE2, PHASE3INTERVENTIONAL

Trial Details

Start: 2023-08-31Est. Completion: 2028-06

Enrollment target: 230 participants

Locations

University of Alabama Hospital, Birmingham, Alabama, United States
University of California San Francisco, San Francisco, California, United States
University of Miami Miller School of Medicine, Miami, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
MetroBoston Clinical Partners, Boston, Massachusetts, United States
Mount Sinai Hospital, New York, New York, United States
Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, United States
Remington-Davis Clinical Research, Columbus, Ohio, United States
Einstein Medical Center, Philadelphia, Pennsylvania, United States
University of Texas, Galveston, Texas, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
The Royal Melbourne Hospital, Parkville, Victoria, Australia
UZ Leuven, Leuven, Belgium
CHU de Nantes - Hôtel Dieu, Service de dermatologie, Nantes, France, France
Centre d'Investigation Clinique (CIC) Hôpital Bichat - Claude-Bernard, Paris, France, France

EPPXLP

To evaluate the long-term safety and tolerability of oral dersimelagon.

Huntington Beach, United StatesEst. completion Dec 2027

Erythropoietic ProtoporphyriaX-linked Protoporphyria

Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) result from genetic defects of heme biosynthesis t…

Boston, United StatesCompleted Apr 24, 2025

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