Trials / Enrolling By Invitation
Enrolling By InvitationNCT05883748
HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP
HELIOS: An Open-Label, Long-Term Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
- Status
- Enrolling By Invitation
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- Sponsor
- Disc Medicine, Inc · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, long-term extension study to investigate the safety, tolerability and efficacy of DISC-1459 in participants with EPP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DISC-1459 | DISC-1459 dose level 1 |
| DRUG | DISC-1459 | DISC-1459 dose level 2 |
Timeline
- Start date
- 2023-08-31
- Primary completion
- 2028-06-01
- Completion
- 2028-06-01
- First posted
- 2023-06-01
- Last updated
- 2025-12-18
Locations
13 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05883748. Inclusion in this directory is not an endorsement.