Trials / Active Not Recruiting
Active Not RecruitingNCT06144840
INcreased Sun Exposure Without Pain In Research Participants With EPP or XLP
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Adults and Adolescents With Erythropoietic Protoporphyria or X-Linked Protoporphyria
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 165 (actual)
- Sponsor
- Tanabe Pharma America, Inc. · Industry
- Sex
- All
- Age
- 12 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dersimelagon | MT-7117 |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2023-12-11
- Primary completion
- 2026-04-01
- Completion
- 2026-06-01
- First posted
- 2023-11-22
- Last updated
- 2025-12-11
Locations
36 sites across 11 countries: United States, Australia, Bulgaria, Czechia, France, Italy, Japan, Netherlands, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06144840. Inclusion in this directory is not an endorsement.