Trials / Completed
CompletedNCT04402489
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria or X-Linked Protoporphyria
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
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 184 (actual)
- Sponsor
- Tanabe Pharma America, Inc. · Industry
- Sex
- All
- Age
- 12 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is 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 aged 12-75.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo |
| DRUG | MT-7117 Low Dose | MT-7117 Low Dose |
| DRUG | MT-7117 High Dose | MT-7117 High Dose |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2021-12-14
- Completion
- 2022-07-26
- First posted
- 2020-05-26
- Last updated
- 2025-12-30
- Results posted
- 2025-03-21
Locations
31 sites across 10 countries: United States, Australia, Canada, Germany, Italy, Japan, Norway, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04402489. Inclusion in this directory is not an endorsement.