Psoriasis (PsO), Randomised Controlled Trial
Conditions
Keywords
Randomized controlled trials
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.
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.
Interventions
DRUGSulodexide
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.
DRUGPlacebo
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.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age is 18-65 years old and gender is not limited; 2. Clinical diagnosis consistent with moderate to severe plaque psoriasis; 3. 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)'); 4. Voluntarily participate in the study and sign the informed consent form before the start of the study.
Exclusion criteria
1. Suffering from severe systemic or localised infections within the last 6 months; 2. Those with bleeding tendency or suffering from bleeding disorders; 3. The presence of malignant tumours, or postoperative tumour patients and those at high risk of tumours; 4. 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.); 5. Treatment with other biological agents within the last 9 months; 6. 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; 7. Infection with other diseases such as Human Immunodeficiency Virus (HIV); 8. 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; 9. Clinically significant abnormal values on screening tests as determined by the investigator; 10. Pregnant women or women of childbearing potential who intend to become pregnant or breastfeeding during the trial period; 11. A positive serum or urine pregnancy test in a female of childbearing potential during the Screening Period; 12. Currently participating in another clinical study or have participated in another clinical study within 3 months; 13. Known presence of alcoholism, drug dependence, or psychiatric disorders 14. Known or suspected to be unable to complete the trial due to poor adherence; 15. Who, in the judgement of the investigator, are unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of appearance of the first psoriatic skin lesion | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis lesion size and severity index score[PASI] | 1 year | Psoriasis lesion size and severity index score |
| Dermatological Quality of Life Index[DLQI] | 1 year | Dermatological Quality of Life Index |
| Self-Rating Anxiety Scale | 1 year | 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. |
| Self-Rating Depression Scale | 1 year | 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. |
| Adverse Events [AEs] | 1 year | AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 |
Countries
China
Outcome results
None listed