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Efficacy and Safety Study of L608 in Patients With Systemic Sclerosis-associated Digital Ulcers

Key facts

Phase
2. fázis

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  4. What happens if I want to stop?
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Trial details

Who runs it
Pharmosa Biopharm Inc.
Trial code
NCT07925619
Record updated
2026. november 9.
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