Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

Conditions

• EPP
• XLP

Eligibility Criteria

Sex

ALL

Age

12 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• MT-7117 — DRUG
  MT-7117

Study Details

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

Key Dates

First listed

Aug 16, 2021

Start date

Aug 10, 2021

Status verified

Aug 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

301 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dersimelagon 200mg

Primary Outcome Measure

Number of patients with Treatment emergent adverse events (TEAEs) (including serious adverse events [SAEs] and adverse events of special interest [AESIs]). [ Time Frame: up to 66 further months ]

Central Contacts

• Clinical Trials Information Desk, To prevent mis-communication,
  please e-mail
  [email protected]

Locations (13)

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