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New drug aims to let sunlight-sensitive patients enjoy the sun longer

NCT ID NCT06144840

Symptom relief Sponsor: Tanabe Pharma America, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called MT-7117 in 165 adults and adolescents (ages 12-75) with erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP), conditions that cause severe pain from sunlight exposure. The goal was to see if the drug could delay the first symptoms of sun sensitivity (like burning or tingling) and reduce pain events. Participants took the drug or a placebo daily for 16 weeks, and researchers measured how long they could stay in the sun before symptoms started.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

165 people

The number who actually took part.

Started

Dec 2023

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects provided written informed consent to participate. For minor subjects, both minor's assent and parental consent will be required. 2. Male and female subjects with a confirmed diagnosis of EPP or XLP based on medical history. 3. Subjects aged 12 years to 75 years, inclusive, at Screening. 4. Subjects are willing and able to travel to the study sites for all scheduled visits. 5. 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). 6. 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. 7. Female subjects of childbearing potential and male subjects with partner of child-bearing potential currently using/willing to use 2 effective methods of contraception. Additional screening criteria check may apply for qualification. Exclusion Criteria: 1. History or presence of photodermatoses other than EPP or XLP. 2. 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. 3. Presence or history of any hepatobiliary disease, including druginduced liver injury at screening, determined as clinically significant by the Investigator after the discussion with the Sponsor Medical Monitor. 4. 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. 5. History (in the last 2 years) or presence of alcohol abuse, or abuse of illicit drugs in the opinion of the Investigator. 6. History of melanoma. 7. 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. 8. 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. 9. 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 DiseaseEpidemiology 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. 10. 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. 11. Female subjects who are pregnant, lactating, or intending to become pregnant during the study. 12. 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, at doses which, in the opinion of the Investigator, may affect study endpoints (including but not limited to beta-carotene, cysteine, pyridoxine). * Chronic treatment with any scheduled analgesic agents including, but not limited to, opioids and opioid derivatives such as morphine, hydrocodone, oxycodone, fentanyl, or their combination with other unscheduled analgesics or non-steroidal anti-inflammatory drug (Percocet and Vicodin-like prescription drugs) within 4 weeks. Note: Acute use of scheduled narcotics more than 3 months prior to randomization are allowed. Non-steroidal anti-inflammatory drug, aspirin for analgesia, or prior temporary use of scheduled agents within 3 months of screening is allowed. 13. 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. 14. Subjects who participated in any previous MT-7117 clinical studies. 15. 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). 16. Use of sunscreens with zinc oxide. Note: Sunscreens without zinc oxide are allowed, however their use, in frequency, quantity and body surface area should be maintained relatively stable throughout the duration of the study. 17. History of any hypersensitivity to the active ingredient and/or excipients (lactose monohydrate, hydroxypropylcellulose, carmellose calcium, magnesium stearate, hypromellose, titanium dioxide, talc, polyethylene glycol, iron oxide yellow, iron oxide red, and iron oxide black). (EU ONLY) 18. Subjects who are unable to swallow tablets or have diseases significantly affecting the gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.(EU ONLY) 19. History of any hypersensitivity to the active ingredient and/or excipients contained in MT-7117 IMP (lactose monohydrate, hydroxypropyl cellulose, carmellose calcium, magnesium stearate, hypromellose, titanium dioxide, talc, polyethylene glycol, iron oxide yellow, iron oxide red, and iron oxide black). (UK ONLY) Additional screening criteria check may apply for qualification.

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Conditions

The condition(s) this trial relates to.

erythropoietic protoporphyria X-linked erythropoietic protoporphyria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erythropoietic protoporphyria (EPP) X-linked protoporphyria (XLP)

Contacts and locations

Locations

  • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Louis-Mourier

    Paris, 92701, France

  • Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

    Brescia, 25123, Italy

  • Azienda Sanitaria Ospedaliera Santa Croce E Carle - Cuneo

    Cuneo, 12100, Italy

  • CHU Nantes

    Nantes, 44000, France

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

    Bordeaux, 33000, France

  • Einstein Medical Center (EMC)

    Philadelphia, Pennsylvania, 19141, United States

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

    Milan, 20122, Italy

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3194, Japan

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital General Universitario De Valencia

    Valencia, 46014, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hôpital Bichat - Hospital Bichat-Hopitaux Universitaires Paris Nord Val de Seine

    Paris, 75018, France

  • IFO-San Gallicano IRCCS

    Rome, 00144, Italy

  • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)

    New York, New York, 10029-0311, United States

  • Institute for Clinical and Experimental Medicine - IKEM

    Prague, 01958, Czechia

  • Instytut Hematologii I Transfuzjologii

    Warsaw, 02-776, Poland

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Materno-Infantile - Burlo Garofolo - Clinica Pediatrica

    Trieste, 34137, Italy

  • Kansas City Research Institute

    Kansas City, Missouri, 64131, United States

  • MGH

    Boston, Massachusetts, 02129, United States

  • Marvel Clinical Research, LLC

    Huntington Beach, California, 92647, United States

  • Mazda Hospital

    Aki-gun, Hiroshima, 735-8585, Japan

  • MetroBoston Clinical Partners, LLC

    Brighton, Massachusetts, 02135-3511, United States

  • Ospedalle Galliera

    Genova, 16128, Italy

  • Remington-Davis Clinical Research

    Columbus, Ohio, 43215, United States

  • Royal Melbourne Hospital (RMH)

    Parkville, Victoria, 03050, Australia

  • The University of Texas Medical Branch (UTMB)

    Galveston, Texas, 77555-0342, United States

  • Tokyo Saiseikai Central Hospital

    Tokyo, 108-0073, Japan

  • U.O.C. Medicina Interna Azienda ospedaliero Universitaria Policlinico di Modena

    Modena, 41124, Italy

  • Universitair Medisch Centrum Rotterdam

    Rotterdam, 03015, Netherlands

  • University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski - Porphyria Center

    Sofia, 01000, Bulgaria

  • University Of Miami School Of Medicine, Center For Liver Diseases

    Miami, Florida, 33136, United States

  • University of California at San Francisco

    San Francisco, California, 94143, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Wake Forest University Baptist Health

    Winston-Salem, North Carolina, 27103, United States

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