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Psoriasis (PsO)Phase 3NCT06982196

Sulodexide in Controlling the Recurrence of Psoriasis

A Phase 3 study testing Sulodexide in people with Psoriasis (PsO) and Randomised Controlled Trial, run by Xijing Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Psoriasis (PsO), Randomised Controlled Trial
What is being tested?
Sulodexide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteChina
Study dates
20 Apr 2025to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • xjjing Hospital

    Xi'an

Other trials in China

About this study

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

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.

Read the 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.
Being tested
Sulodexide, Placebo
Keywords
Randomized controlled trials
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SulodexideDrug

    Also called Vessel Due F (international brand)

    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.

  • PlaceboDrug

    Also called Matching placebo for sulodexide soft capsules

    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.

Study groups in NCT06982196
Study groupRoleWhat they receive
Sulodexide GroupExperimentalParticipants 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.
Receives: Drug: Sulodexide
Placebo Comparator GroupPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (5)
  1. Psoriasis lesion size and severity index score[PASI]

    Psoriasis lesion size and severity index score

    Measured: 1 year

  2. Dermatological Quality of Life Index[DLQI]

    Dermatological Quality of Life Index

    Measured: 1 year

  3. Self-Rating Anxiety Scale

    The Self-Rating Anxiety Scale (SAS) is a validated 20-item questionnaire used to assess the severity of anxiety symptoms in participants. Each item is scored on a 4-point Likert scale (1 = "None or a little of the time" to 4 = "Most or all of the time"), with higher total scores indicating greater anxiety levels.

    Measured: 1 year

  4. Self-Rating Depression Scale

    The Self-Rating Depression Scale (SDS) is a widely used psychological assessment tool designed to measure the intensity and presence of depressive symptoms in individuals.

    Measured: 1 year

  5. Adverse Events [AEs]

    AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2025
  2. Study start20 Apr 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06982196
Sponsor's protocol ID
KY20242407-C-1
Status last verified
Dec 2024
First submitted
13 May 2025
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33812489
  • 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.

    PubMed 32427307
  • 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.

    PubMed 35601055
  • 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.

    PubMed 31595056
  • 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.

    PubMed 32365242
  • 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.

    PubMed 31899186
  • 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.

    PubMed 32888954
  • 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.

    PubMed 33995668
  • 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.

    PubMed 36917196

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sulodexide in people with Psoriasis (PsO) and Randomised Controlled Trial, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time of appearance of the first psoriatic skin lesion (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06982196, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.

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