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New drug may let people with rare sun allergy enjoy the outdoors longer

NCT ID NCT04402489

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 184 people aged 12 to 75 with erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP), rare conditions that cause severe pain from sunlight. The goal was to see if the drug could delay the first signs of sun sensitivity (burning, tingling, itching, or stinging) and reduce pain. Participants took the drug or a placebo daily for 26 weeks and recorded their sun exposure and symptoms.

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

184 people

The number who actually took part.

Started

Jun 2020

Finished

Jul 2022

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.

Additional screening criteria check may apply for qualification. Inclusion Criteria: 1. Subjects provided written informed consent to participate. For minor subjects, both minor assent and parental consent will be provided. 2. Male and female subjects with a confirmed diagnosis of EPP or XLP based on medical history, aged 12 years to 75 years, inclusive, at Screening. 3. Subjects have a body weight of ≥30 kg. 4. Subjects are willing and able to travel to the study sites for all scheduled visits. 5. In the Investigator's opinion, subject is able to 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). 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 including barrier method as described in the protocol. Exclusion Criteria: 1. History or presence of photodermatoses other than EPP or XLP. 2. Subjects who are unwilling or unable to go outside during daylight hours most days (e.g., between 1 hour post sunrise and 1 hour pre-sunset) during the study. 3. Presence of clinically significant hepatobiliary disease based on LFT values at Screening. 4. Subjects with AST, ALT, ALP ≥3.0 × upper limit of normal (ULN) or total bilirubin \>1.5 × ULN at Screening. 5. Subjects with or having a history (in the last 2 years) of excessive alcohol intake in the opinion of the Investigator. 6. History of melanoma. 7. Presence of melanoma and/or lesions suspicious for melanoma at Screening. 8. History of familial melanoma (defined as having 2 or more first-degree relatives, such as parents, sibling and/or child). 9. 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. 10. 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. 11. Presence of clinically significant acute or chronic renal disease based upon the subject's medical records including hemodialysis; an estimated glomerular filtration rate (eGFR) \<60 mL/min as calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKDEPI) creatinine equation (2009) for adults and by the Schwartz creatinine equation for adolescents (2009). Modification of Diet in Renal Disease (MDRD) can be used for adults per local recommendations. 12. 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. 13. Female subjects who are pregnant, lactating, or intending to become pregnant during the study. 14. Treatment with phototherapy within 3 months before Randomization (Visit 2). 15. Treatment with afamelanotide within 3 months before Randomization (Visit 2). 16. Treatment with cimetidine within 4 weeks before Randomization (Visit 2). 17. Treatment with antioxidant agents within 4 weeks before Randomization (Visit 2), at doses which, in the opinion of the Investigator, may affect study endpoints (including but not limited to beta-carotene, cysteine, pyridoxine). 18. 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 before Randomization (Visit 2). Acute use of scheduled narcotics greater than 3 months prior to randomization, OTCs, such as NSAIDs or aspirin for analgesia, or prior temporary use of scheduled agents within 3 months of screening are not excluded. 19. Treatment 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. 20. Previous exposure to MT-7117 (this does not include placebo treated subjects). 21. Previous treatment with any investigational agent within 12 weeks before Screening OR 5 half-lives of the investigational product (whichever is longer).

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Conditions

The condition(s) this trial relates to.

erythropoietic protoporphyria protoporphyria, erythropoietic, 1 X-linked erythropoietic protoporphyria X-linked lymphoproliferative disease due to SH2D1A deficiency

As listed by the trial registrant

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

EPP XLP

Contacts and locations

Locations

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

    Brescia, 1 25123, Italy

  • Charite - Universitaetsmedizin Berlin

    Berlin, 10117, Germany

  • Evelina London Children's Hospital - Guy's & St Thomas' NHS Foundation Trust

    London, SE1 7EH, United Kingdom

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

    Milan, 20122, Italy

  • Haukeland University Hospital

    Bergen, Norway

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • I.F.O Hospital Centro Porfirie e Malattie Rare

    Rome, 144 Rome RM, Italy

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

    New York, New York, 10029, United States

  • Investigator site

    Sayama, Osaka, Japan

  • Kansas City Research Institute

    Kansas City, Missouri, 64131, United States

  • Karolinska University Hospital

    Stockholm, 171 64, Sweden

  • Kobe University Hospital

    Kobe, Hyōgo, Japan

  • Marvel Clinical Research, LLC

    Huntington Beach, California, 92647, United States

  • MetroBoston Clinical Partners, LLC

    Brighton, Massachusetts, 02135, United States

  • Osaka Medical College Hospital

    Takatsuki, Osaka, Japan

  • Remington-Davis Clinical Research

    Columbus, Ohio, 43215, United States

  • Royal Melbourne Hospital (RMH)

    Melbourne, Victoria, 3050, Australia

  • Sophia Dermatology Clinic

    Kanazawa, Ishikawa-ken, 921-8035, Japan

  • The University of Texas Medical Branch (UTMB)

    Galveston, Texas, 77555, United States

  • The Wesley Hospital

    Brisbane, Queensland, 4066, Australia

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tokyo Saiseikai Central Hospital

    Minato-ku, Tokyo, Japan

  • Toyama University Hospital

    Sugitani, Toyama, 930-0194, Japan

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

    Modena, 41125, Italy

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

    Miami, Florida, 33136, United States

  • University of Alberta

    Edmonton, Alberta, AB T6G 2R3, Canada

  • University of Manchester

    Salford, Manchester, M13 9PL, United Kingdom

  • University of Washington-Seattle Cancer Care Alliance

    Seattle, Washington, 19023, United States

  • Wake Forest University Baptist Health

    Winston-Salem, North Carolina, 27109, United States

  • Westfaelische Wilhelms-Universitaet Muenster

    Münster, Northrhein Westalien, 48149, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.