Sulodexide in Controlling the Recurrence of Psoriasis

NCT06982196 | Enrolling By Invitation Phase 3

• 1 other identifier: KY20242407-C-1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis (PsO); Randomised Controlled Trial

Keywords

Randomized controlled trials

Outcome Measures

Primary Outcomes (1)

• Time of appearance of the first psoriatic skin lesion

  This outcome measures the duration (in days) from the start of the study intervention (sulodexide or placebo) until the first identifiable recurrence of a characteristic psoriatic skin lesion in participants who had previously achieved complete clearance (PASI 100) with secukinumab therapy.

  1 year

Secondary Outcomes (5)

• Psoriasis lesion size and severity index score[PASI]

  1 year

• Dermatological Quality of Life Index[DLQI]

  1 year

• Self-Rating Anxiety Scale

  1 year

• Self-Rating Depression Scale

  1 year

• Adverse Events [AEs]

  1 year

Study Arms (2)

Sulodexide Group

EXPERIMENTAL

Participants in this group will receive oral sulodexide soft capsules (manufactured by Alfa Wassermann, Italy; approval number H20140119, specification 250 LSU) after discontinuing secukinumab. The dosing regimen is 1 capsule twice daily for 120 consecutive days or until psoriasis relapse is confirmed. Sulodexide, a vascular protective agent, aims to prolong psoriasis recurrence by improving vascular endothelial barrier function. During the study, disease relapse (assessed via PASI scores) and safety indicators (e.g., adverse events, laboratory tests) will be regularly monitored.

Drug: Sulodexide

Placebo Comparator Group

PLACEBO COMPARATOR

Participants in this group will receive matching placebo capsules orally after discontinuing secukinumab. The dosing regimen is 1 capsule twice daily for 120 consecutive days or until psoriasis relapse is confirmed. The placebo capsules are identical in appearance and packaging to the active sulodexide capsules but contain no active pharmaceutical ingredients. This group serves as a control to evaluate the efficacy of sulodexide in delaying psoriasis recurrence. Disease relapse (assessed via PASIscores) and safety indicators (e.g., adverse events, laboratory tests) will be monitored at the same intervals as the experimental group.

Drug: Placebo

Interventions

Sulodexide DRUG

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.

Also known as: Vessel Due F (international brand)

Sulodexide Group

Placebo DRUG

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.

Also known as: Matching placebo for sulodexide soft capsules

Placebo Comparator Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is 18-65 years old and gender is not limited;
• Clinical diagnosis consistent with moderate to severe plaque psoriasis;
• After receiving standardised treatment with strychnicolizumab for 3 months to achieve complete clearing of skin lesions (in accordance with PASI 100 or PGA 0), and then continuing the treatment for 6 months without symptomatic relapse to satisfy the criteria for discontinuation of the drug and discontinuing strychnicolizumab (refer to the recommendations of 'Guidelines for the treatment of psoriasis with biologics in China (2021 edition)');
• Voluntarily participate in the study and sign the informed consent form before the start of the study.

You may not qualify if:

• Suffering from severe systemic or localised infections within the last 6 months;
• Those with bleeding tendency or suffering from bleeding disorders;
• The presence of malignant tumours, or postoperative tumour patients and those at high risk of tumours;
• Have received or currently require treatment with other anticoagulant drugs such as sulodexide drugs within the last 9 months (e.g. argatroban, bivalirudin, dabigatran etexilate, desirudin, lepirudin, aspirin, etc.);
• Treatment with other biological agents within the last 9 months;
• Highly allergic or with a history of severe allergies; allergy to heparin or heparin analogues; or known/suspected allergy to one of the components of the investigational drug;
• Infection with other diseases such as Human Immunodeficiency Virus (HIV);
• Serious, progressive, uncontrolled disorders of vital organs and systems (including cardiovascular, hepatic, pulmonary, and renal) and other diseases that, in the opinion of the investigator, are not suitable for participation in the study in combination;
• Clinically significant abnormal values on screening tests as determined by the investigator;
• Pregnant women or women of childbearing potential who intend to become pregnant or breastfeeding during the trial period;
• A positive serum or urine pregnancy test in a female of childbearing potential during the Screening Period;
• Currently participating in another clinical study or have participated in another clinical study within 3 months;
• Known presence of alcoholism, drug dependence, or psychiatric disorders
• Known or suspected to be unable to complete the trial due to poor adherence;
• Who, in the judgement of the investigator, are unsuitable for participation in this clinical study.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

xjjing Hospital

Xi'an, China

Location

Related Publications (9)

• Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021 Apr 3;397(10281):1301-1315. doi: 10.1016/S0140-6736(20)32549-6.

  PMID: 33812489 BACKGROUND

• Armstrong AW, Read C. Pathophysiology, Clinical Presentation, and Treatment of Psoriasis: A Review. JAMA. 2020 May 19;323(19):1945-1960. doi: 10.1001/jama.2020.4006.

  PMID: 32427307 BACKGROUND

• Tian D, Lai Y. The Relapse of Psoriasis: Mechanisms and Mysteries. JID Innov. 2022 Mar 9;2(3):100116. doi: 10.1016/j.xjidi.2022.100116. eCollection 2022 May.

  PMID: 35601055 BACKGROUND

• Chen L, Shen Z. Tissue-resident memory T cells and their biological characteristics in the recurrence of inflammatory skin disorders. Cell Mol Immunol. 2020 Jan;17(1):64-75. doi: 10.1038/s41423-019-0291-4. Epub 2019 Oct 8.

  PMID: 31595056 BACKGROUND

• Yelamos O, Alejo B, Ertekin SS, Villa-Crespo L, Zamora-Barquero S, Martinez N, Dominguez M, Iglesias P, Herrero A, Malvehy J, Puig S. Non-invasive clinical and microscopic evaluation of the response to treatment with clobetasol cream vs. calcipotriol/betamethasone dipropionate foam in mild to moderate plaque psoriasis: an investigator-initiated, phase IV, unicentric, open, randomized clinical trial. J Eur Acad Dermatol Venereol. 2021 Jan;35(1):143-149. doi: 10.1111/jdv.16559. Epub 2020 Jul 6.

  PMID: 32365242 BACKGROUND

• Zhu Z, Chen J, Lin Y, Zhang C, Li W, Qiao H, Fu M, Dang E, Wang G. Aryl Hydrocarbon Receptor in Cutaneous Vascular Endothelial Cells Restricts Psoriasis Development by Negatively Regulating Neutrophil Recruitment. J Invest Dermatol. 2020 Jun;140(6):1233-1243.e9. doi: 10.1016/j.jid.2019.11.022. Epub 2019 Dec 30.

  PMID: 31899186 BACKGROUND

• Chen J, Zhu Z, Li Q, Lin Y, Dang E, Meng H, Sha N, Bai H, Wang G, An S, Shao S. Neutrophils Enhance Cutaneous Vascular Dilation and Permeability to Aggravate Psoriasis by Releasing Matrix Metallopeptidase 9. J Invest Dermatol. 2021 Apr;141(4):787-799. doi: 10.1016/j.jid.2020.07.028. Epub 2020 Sep 2.

  PMID: 32888954 BACKGROUND

• Li Q, Zhu Z, Wang L, Lin Y, Fang H, Lei J, Cao T, Wang G, Dang E. Single-cell transcriptome profiling reveals vascular endothelial cell heterogeneity in human skin. Theranostics. 2021 Apr 19;11(13):6461-6476. doi: 10.7150/thno.54917. eCollection 2021.

  PMID: 33995668 BACKGROUND

• Li Q, Shao S, Zhu Z, Chen J, Hao J, Bai Y, Li B, Dang E, Wang G. An IGFBP7hi endothelial cell subset drives T cell extravasation in psoriasis via endothelial glycocalyx degradation. J Clin Invest. 2023 May 1;133(9):e160451. doi: 10.1172/JCI160451.

  PMID: 36917196 BACKGROUND

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MeSH Terms

Conditions

Psoriasis

Interventions

glucuronyl glucosamine glycan sulfate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gang Wang

  xjjing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)