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Not yet recruitingPhase 2

Testing L608 for digital ulcers linked to systemic sclerosis

Tests L608 against placebo in adults with systemic sclerosis-associated digital ulcers.

Plain-language title generated from the registry record
Registry title: Efficacy and Safety Study of L608 in Patients With Systemic Sclerosis-associated Digital Ulcers

Key facts

Phase
Phase 2

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Trial details

Who runs it
Pharmosa Biopharm Inc.
Trial code
NCT07925619
Record updated
9 November 2026
Original description
This trial is designed to evaluate the efficacy and safety of L608 compared to placebo in patients with SSc-DU.Read full original descriptionShow less

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of L608 Suspension in Patients With Systemic Sclerosis-associated Digital Ulcers

This trial is designed to evaluate the efficacy and safety of L608 compared to placebo in patients with SSc-DU.

Inclusion: Diagnosed with systemic sclerosis per ACR/EULAR 2013 criteria; Presence of at least one visible, painful digital ulcer; Participants aged ≥18 years.

Exclusion: Active gangrene (within 3 months) or active DU infection requiring treatment (within 1 month) prior to screening; Other rheumatic diseases are permitted if SSc is the predominant condition associated with DUs; DUs not primarily ischemic in origin.

ClinicalTrials.gov NCT07925619