RecruitingPhase 3

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

United States301 participantsStarted 2021-08-10

Plain-language summary

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

Who can participate

Age range12 Years – 75 Years

SexALL

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Exclusion criteria

✕. Drugs known to be predominantly metabolized by cytochrome P450 (CYP) 3A4 with a narrow therapeutic index for which elevated plasma concentrations are associated with clinical safety concern or significant medical events.
✕. Drugs that are known substrates of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporting polypeptide (OATP)1B1, or OATP1B3 for which elevated plasma concentrations are associated with significant medical events.

What they're measuring

Number of patients with Treatment emergent adverse events (TEAEs) (including serious adverse events [SAEs] and adverse events of special interest [AESIs]).

Timeframe: up to 66 further months

Number of patients with abnormal Physical examination data

Timeframe: up to 66 further months

Number of patients with Nevi appearance

Timeframe: up to 66 further months

Trial details

NCT IDNCT05005975

SponsorTanabe Pharma America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Clinical Trials Information Desk, To prevent mis-communication,

please e-mail information.US@mb.tanabe-pharma.com

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