NCT06982196

Sulodexide in Controlling the Recurrence of Psoriasis

Multicenter, Randomized, Double-blinded，Controlled Clinical Study to Evaluate the Efficacy and Safety of Sulodexide in Controlling the Recurrence of Psoriasis

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blinded，controlled clinical trial. The purpose of the study is to evaluate the efficacy and safety of Sulodexide versus placebo in preventing psoriasis recurrence in patients with plaque psoriasis who have discontinued biologic therapy after achieving clinical cure.

Detailed description

It was planned to include 160 patients with psoriasis vulgaris who met the inclusion criteria for discontinuation of biologics after reaching the standard of treatment and were randomised in a 1:1 ratio to receive oral treatment with sulodexide soft capsules or placebo capsules, respectively. 1. Sulodexide group： Starting after the last injection of secukinumab, oral treatment with sulodexide soft capsule (Alpha Weissmann Pharmaceuticals, Italy, approval number H20140119, specification 250 LSU) was given as 1 tab bid for 120 days or discontinued after judged to be a relapse; 2. Control group: Oral treatment with placebo capsule, 1 tab bid starting after the last injection of secukinumab, discontinued after 120 days of continuous oral administration or judged to be discontinued for relapse.

Conditions

• Psoriasis (PsO)
• Randomised Controlled Trial

Interventions

Type	Name	Description
DRUG	Sulodexide	Sulodexide group：Starting after the last injection of secukinumab, oral treatment with sulodexide soft capsule (Alpha Weissmann Pharmaceuticals, Italy, approval number H20140119, specification 250 LSU) was given as 1 tab bid for 120 days or discontinued after judged to be a relapse.
DRUG	Placebo	Control group: Oral treatment with placebo capsule, 1 tab bid starting after the last injection of secukinumab, discontinued after 120 days of continuous oral administration or judged to be discontinued for relapse.

Timeline

• Start date: 2025-04-20
• Primary completion: 2026-06-30
• Completion: 2027-12-31
• First posted: 2025-05-21
• Last updated: 2025-05-21

Locations

1 site across 1 country: China