INSPIRE (INcreased Sun exposure without Pain In Research subjects with EPP)
Research type
Research Study
Full title
MT-7117-A-302 Study: 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
IRAS ID
1009251
Contact name
Hiva Fassihi
Contact email
Sponsor organisation
Mitsubishi Tanabe Pharma America, Inc.
Clinicaltrials.gov Identifier
Research summary
This study involves an experimental drug named MT-7117 (dersimelagon) used for the treatment of Erythropoietic Protoporphyria (referred to as “EPP”) or X-Linked Protoporphyria (referred to as “XLP”). EPP or XLP are rare inherited metabolic disorders characterised by the accumulation of a molecule named protoporphyrin in the body, which leads to burning and severe pain when the skin is exposed to sunlight. The research study is divided into four periods; Screening (4 weeks), Double-blind Treatment Period (16 weeks), Open-label Extension Period (36 weeks) and End of Study (EOS)/ Follow Up Period (6 weeks). The total study duration is up to 62 weeks.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0051
Date of REC Opinion
25 Mar 2024
REC opinion
Further Information Favourable Opinion