A pill that could let people with rare sunlight disorder step outside without pain

NCT ID NCT07820085

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing an oral drug called PORT-77 in people with erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), rare conditions that cause severe pain after sunlight exposure. The trial enrolls about 225 adults and adolescents aged 12 and older. It compares PORT-77 with a placebo to see whether the drug lowers a harmful substance called PPIX in the blood and increases the amount of time participants can spend in sunlight without pain. An open-label extension follows participants longer to check safety and lasting effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PORT-77, an experimental oral tablet
What this could lead to
If PORT-77 works, it could give people with EPP or XLP a daily pill that lowers the toxic buildup behind their sun sensitivity and lets them spend more time outdoors without pain.
What could go wrong
The trial is still testing whether PORT-77 lowers PPIX and improves sun tolerance, so the drug may not work or may cause side effects. Results in this group may not apply to everyone with these conditions.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

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 years and older

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: * Aged 12 years or older. * Clinical history of EPP, XLP, or EPP2 supported by genetic confirmation or historical laboratory test results * History of consistent, non-painful prodrome within approximately 45 minutes of sunlight exposure and prior to phototoxic attacks * Demonstrates ≥85% compliance with daily symptom diary during run-in period. * Body weight or BMI at Screening as follows: 1. For participants aged 12 to \<18 years: body weight ≥32 kg 2. For participants aged ≥18 years: BMI ≥18.5 kg/m2 * AST and ALT \<3 × ULN and total bilirubin \<2 × ULN (unless documented Gilbert syndrome) at Screening * Willing and able to provide informed consent and/or assent for the study. * Willing and able to comply with study visits, study procedures, and contraception guidance * Intends to remain in the same approximate geographic latitude for the duration of the placebo-controlled period, with no more than 14 days spent outside this region. Exclusion Criteria: * Diagnosis of another porphyria or another photodermatosis that may confound the evaluation of PORT-77 * Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory assessments * Major surgery within 8 weeks before Screening, incomplete recovery from any previous surgery, or major surgery planned to occur during the study * History of, or anticipated need for, liver transplantation or history of bone marrow transplantation * Active infection with hepatitis B or C * Unable to swallow tablets or has a disease that significantly affects gastrointestinal function * Any other disease, condition, or circumstance that, at the discretion of the Investigator or Sponsor, would interfere with the evaluation of PORT-77 or study participation, or would make study participation not in the best interest of the participant * History of drug or alcohol abuse within the last 12 months, or current or planned use of prohibited or illegal substances * Has taken any medication, vitamin, or supplement that alters sensitivity to light exposure (eg, afamelanotide, melanotan, beta carotene, dersimelagon) within 90 days of Day 1; or has taken bitopertin within 120 days of Day 1; or has taken iron within 30 days of Day 1 * Drugs or supplements that may impact or be impacted by PORT-77 * Concurrent or anticipated participation in an interventional clinical trial during the study period. * Received another investigational therapy within 5 half-lives, if the half-life is known, or within 30 days, if the half-life is unknown, prior to Day 1. * Known hypersensitivity to PORT-77 or excipients * Female who has a positive pregnancy test at Screening or Day 1 or is breastfeeding

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for EPP2 are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Investigative Site

    RECRUITING

    Huntington Beach, California, 92647, United States

  • Investigative Site

    RECRUITING

    Cincinnati, Ohio, 43215, United States

More trials for these conditions

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