GATEWAY: A Phase 2a Study of PORT-77 in Adults With Erythropoietic Protoporphyria

A Phase 2a, Blinded, Randomized, Placebo-Controlled Study of PORT-77 Administered Orally to Adults With Erythropoietic Protoporphyria

NCT06971900•Portal Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

A Phase 2a study of PORT-77 in adults with erythropoietic protoporphyria (EPP)

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•BMI ≥18.0 and ≤35.0 kg/m2 and weight ≥50 kg
•Known diagnosis of EPP and is currently symptomatic even if receiving treatment for EPP, including afamelanotide.
•Willing and able to avoid exposure to sunlight when outside of the clinical research site.
•Willing and able to follow protocol-specified contraception guidance.
•Able to read and understand English
•Able to understand the study procedures as described in the ICF and is willing and able to comply with the study requirements.

Exclusion Criteria

•Is mentally or legally incapacitated
•History or presence of any illness or clinically significant medical or psychiatric condition or disease that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study.
•History of gastrointestinal condition, including surgeries, which may affect absorption after oral administration.
•History of cancer, with the exception of cutaneous non-melanoma skin cancer (basal or squamous cell carcinoma).
•Participation in another clinical study within 28 days or within 5 half-lives (if known), prior to screening
•Unable to refrain from or anticipates the use of medications/supplements known to confound PORT-77 beginning 28 days (or 5 half-lives, whichever is longer) prior to the first dose of study drug and throughout the study.
•Estimated glomerular filtration rate \<80 mL/min/1.73 m2 using the CKD-EPI equation at screening
•Hepatic impairment, with alanine aminotransferase, aspartate aminotransferase, or total bilirubin \>1.5 x ULN at screening
•Female participant with a positive pregnancy test at screening or who is breastfeeding.

Locations (1)

Celerion

Tempe, Arizona, United States

Key Dates

Start Date

April 4, 2025

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2026

Last Updated

May 14, 2025

Enrollment

ESTIMATED participants

Conditions

Erythropoietic Protoporphyria (EPP)

Interventions

PORT-77

DRUG

Placebo

DRUG

Study of Bitopertin in Participants With EPP or XLP (APOLLO)

NCT06910358

Erythropoietic Protoporphyria (EPP)X-Linked Protoporphyria (XLP)

View study

TERMINATEDNA

Effect of Isoniazid on Protoporphyrin Levels in Erythropoietic Protoporphyria

NCT01550705

Erythropoietic Protoporphyria (EPP)X Linked Erythropoietic Protoporphyria

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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