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INSPIRE (INcreased Sun exposure without Pain In Research subjects with EPP).
EU CTIS ID: 2023-506735-15-00
What this study is testing
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 Erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects provided written informed consent to participate. For minor subjects, both minor’s assent and legal representative´s consent will be required.
- Male and female subjects with a confirmed diagnosis of EPP or XLP based on medical history.
- Subjects aged 12 years to 75 years, inclusive, at Screening.
- Subjects are willing and able to travel to the study sites for all scheduled visits.
- In the Investigator’s opinion, subject can understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements (including travel and receiving direct sunlight exposure as much as possible).
- Female subjects who are non-lactating and have a negative urine pregnancy test at baseline visit prior to receiving the first dose of study drug.
You likely can't join if
- History or presence of photodermatoses other than EPP or XLP.
- Previous treatment with any investigational agent such as bitopertin within 12 weeks before Screening OR 5 half-lives of the investigational product (whichever is longer).
- Subjects who are unwilling or unable to go outside in sunlight during daylight hours most days (e.g., between 1-hour post-sunrise and 1 hour pre-sunset) during the study.
- Use of sunscreens with zinc oxide.
- Presence or history of any hepatobiliary disease, including drug-induced liver injury at screening, determined as clinically significant by the Investigator after the discussion with the Sponsor Medical Monitor.
- Subjects with Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) ≥ 2.0 × upper limit of normal (ULN) or total bilirubin >1.5 × ULN at Screening.
See the full eligibility criteria
Who can join
- Subjects provided written informed consent to participate. For minor subjects, both minor’s assent and legal representative´s consent will be required.
- Male and female subjects with a confirmed diagnosis of EPP or XLP based on medical history.
- Subjects aged 12 years to 75 years, inclusive, at Screening.
- Subjects are willing and able to travel to the study sites for all scheduled visits.
- In the Investigator’s opinion, subject can understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements (including travel and receiving direct sunlight exposure as much as possible).
- Female subjects who are non-lactating and have a negative urine pregnancy test at baseline visit prior to receiving the first dose of study drug.
- Female subjects of childbearing potential and male subjects with partner of childbearing potential currently using/willing to use 2 effective methods of contraception
What rules you out
- History or presence of photodermatoses other than EPP or XLP.
- Previous treatment with any investigational agent such as bitopertin within 12 weeks before Screening OR 5 half-lives of the investigational product (whichever is longer).
- Subjects who are unwilling or unable to go outside in sunlight during daylight hours most days (e.g., between 1-hour post-sunrise and 1 hour pre-sunset) during the study.
- Use of sunscreens with zinc oxide.
- Presence or history of any hepatobiliary disease, including drug-induced liver injury at screening, determined as clinically significant by the Investigator after the discussion with the Sponsor Medical Monitor.
- Subjects with Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) ≥ 2.0 × upper limit of normal (ULN) or total bilirubin >1.5 × ULN at Screening.
- History (in the last 2 years) or presence of alcohol abuse, or abuse of illicit drugs in the opinion of the Investigator.
- History of melanoma.
- Presence of squamous cell carcinoma, basal cell carcinoma, or other malignant skin lesions. Any suspicious lesions or nevi will be evaluated. If the suspicious lesion or nevi cannot be resolved through biopsy or excision, the subject will be excluded from the study.
- History or presence of psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation and/or safety of the subjects.
- Presence of clinically significant acute or chronic renal disease or subjects with an estimated glomerular filtration rate (eGFR) <60 mL/min as calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) for adults and by the Schwartz creatinine equation for adolescents (2009). Modification of Diet in Renal Disease can be used for adults per local recommendations.
- Presence of any clinically significant disease or laboratory abnormality which, in the opinion of the Investigator, can interfere with the study objectives and/or safety of the subjects.
- Female subjects who are pregnant, lactating, or intending to become pregnant during the study.
- Treatment with any of the following medications or therapy within each period before Randomization (Visit 2): - Afamelanotide within 3 months; - Phototherapy within 3 months; - Cimetidine within 4 weeks; - Antioxidant agents within 4 weeks; - Chronic treatment with any scheduled analgesic agents.
- Dermatological treatments with any drugs or supplements which, in the opinion of the Investigator, can interfere with the objectives of the study or safety of the subjects at screening such as, for example, tanning agents.
- Subjects who participated in any previous MT-7117 clinical studies.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United Kingdom
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United Kingdom; United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.