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A Study to Investigate PORT-77 Oral Dosing Compared With Placebo in Participants With Erythropoietic Protoporphyria (EPP) or X-linked Protoporphyria (XLP)

Study acronym: PATHWAY
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
PATHWAY is a Phase 2b/3 clinical study with an Open-Label Extension (OLE). It tests PORT-77 in patients with EPP, EPP2, and XLP. The study has three parts: Part 1: Phase 2b * Find the right dose of PORT-77 to lower PPIX levels in the blood * Test if PORT-77 lowers PPIX levels better than placebo * Check the safety of each dose Part 2: Phase 3 * Test if PORT-77 lowers PPIX levels better than placebo * Test if PORT-77 increases the amount of time patients spend in sunlight each day without pain compared to placebo * Check the safety of PORT-77 Part 3: Open-Label Extension (OLE) * Test the long-term effect of PORT-77 on PPIX levels and time in sun * Monitor long-term safety
Trial Details
NCT Number NCT07820085
Lead Sponsor Portal Therapeutics, Inc.
Conditions
(from sponsor)		 Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP), EPP2
Related terms Protoporphyria, Erythropoietic, Protoporphyria, Erythropoietic, X-Linked Dominant
Enrollment 225 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov