Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine

Study Overview
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Brief Summary
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The purpose of this study is to objectively and standardly evaluate the clinical efficacy and safety of sequential treatment of psoriasis with traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial.

Detailed Description
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Psoriasis is a chronic, recurrent, inflammatory disease. The incidence of this disease is increasing year by year, seriously affecting people's quality of life. Biologic agents have the advantages of rapid and efficient treatment of moderate and severe psoriasis, but their safety and recurrence are still seriously affect the application. Traditional Chinese medicine treatment of psoriasis has the advantages of fewer adverse reactions, low recurrence rate and improvement of patients' systemic symptoms while exerting the curative effect. The prevention and treatment of psoriasis by combining traditional Chinese and Western medicine has become the academic consensus. The sequential treatment of psoriasis with biological agents combined with Traditional Chinese medicine has a better therapeutic effect than that of single therapy. At present, the sequential treatment of psoriasis with targeted biological agents combined with traditional Chinese medicine has not been reported in the literature, and there is a lack of high-level clinical evidence to support it. Therefore, this project aims to provide evidence support for the clinical efficacy and safety of sequential treatment of psoriasis by traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial.

Official Title
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A Multi-center, Randomized, Double-blind Controlled Study on the Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Ixekizumab+Jueyin Granules
* Drug: Ixekizumab+Jueyin placebo Granules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: It conforms to the western diagnostic criteria of plaque psoriasis and the diagnostic criteria of TCM syndrome of blood heat syndrome; Physician global assessment (PGA) ≥3, psoriasis area and severity index (PASI) score ≥12, and body surface area (BSA) ≥ 10% at screening and baseline; Aged between 18 and 70; Those who voluntarily participate in the study and sign the informed consent. Exclusion Criteria: Erythrodermic psoriasis patients, arthropathic psoriasis patients, pustular psoriasis patients; There are other active skin diseases that may affect the evaluator; Have systematically received other investigational drugs within 1 month; Received external glucocorticoid and phototherapy within 2 weeks; During a period of severe and uncontrollable local or systemic acute or chronic infection; Infected persons with tuberculosis; Patients with viral hepatitis; Serious systemic disease; Or clinical test indicators belong to one of the following cases of patients: alanine aminotransferase or glutamic-oxalacetic transaminase increase > 1.5 times the upper limit of normal value; Creatinine increase > 1.5 times the upper limit of normal value; Any one of the major blood routine indicators (white blood cell count, red blood cell count, hemoglobin amount, platelet count) is lower than the lower limit of normal value; Or other abnormal laboratory tests determined by the investigator to be unsuitable for the study; Patients with a history of malignant tumor and patients with primary or secondary immune deficiency and hypersensitivity; Participants in clinical trials of other drugs within 3 months; Those who have undergone major surgery within 8 weeks or will require such surgery during the study period; For fertile women of childbearing age who did not use highly effective contraception from the screening period until the end of the last dose; Pregnant or lactating women; Persons with a history of alcohol, drug or substance abuse; Persons with a serious history of mental illness or family history; For other reasons, the researcher considers it inappropriate to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ixekizumab (4 weeks) + Jueyin Granules (12 weeks)<br>Subjects received Ixekizumab in the first 4 weeks (biologic treatment period); After the cessation of biologic treatment, only Jueyin Granules was used in the 12-week traditional Chinese medicine treatment period. | Drug: Ixekizumab+Jueyin Granules<br>* Ixekizumab：160mg was injected subcutaneously at week 0 (80mg twice), then 80mg at week 2 and 4 (once). Jueyin Granules：Put each bag of daily dose into the same container, pour about 50ml warm water into it, stir until the particles are basically dissolved, then add proper amount of boiling water to dilute it, take it warm in two times.<br>|
| Placebo Comparator: Ixekizumab (4 weeks) + Jueyin placebo Granules(12 weeks)<br>Subjects received Ixekizumab in the first 4 weeks (biologic treatment period); After the cessation of biologic treatment, only Jueyin placebo Granules was used in the 12-week traditional Chinese medicine treatment period. | Drug: Ixekizumab+Jueyin placebo Granules<br>* Ixekizumab：160mg was injected subcutaneously at week 0 (80mg twice), then 80mg at week 2 and 4 (once). Jueyin placebo Granules：Put each bag of daily dose into the same container, pour about 50ml warm water into it, stir until the particles are basically dissolved, then add proper amount of boiling water to dilute it, take it warm in two times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis area and severity index (PASI) | Psoriasis area and severity index (PASI) score and recurrence assessment. Psoriasis area and severity index (PASI) scores were assessed for all patients at each follow-up. Recurrence was defined as a 50% reduction in maximum PASI improvement from baseline at week 40. | Up to 168 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body surface area (BSA) | The percentage of BSA involved in psoriasis is estimated by fingerprinting, where the entire palm of the patient represents approximately 1% of the total BSA. The number of handprints on psoriasis skin in a body part is used to determine the extent to which the body part is affected by psoriasis (%). | Up to 168 days after treatment | 
| Physician Global Assessment (PGA) | Physician Global Assessment (PGA)is scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I),desquamation (D) across all psoriatic lesions. lt is calculated as follows: PGA score = (E +I+D) / 3 then the score needs to be rounded to the nearest whole number [PGA scale: Clear (0)-Very Severe (5)]. | Up to 168 days after treatment | 
| Dermatology Life quality index(DLQI) | The Dermatology Life Quality Index (DLQI) is a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores range from 0-30, a higher score indicating a greater impact on a participant's quality of life. | Up to 168 days after treatment | 
| Patient-reported quality of life (PRQoL) | PRQoL is used to assess the impact of psoriasis on individual social life. Scores range from 0-25, a higher score indicating a greater impact on a participant's social life. | Up to 168 days after treatment | 
| Visual Analogue Score (VAS) | Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 100 mm at eash visit (with 0 being no pruritis and 100 being maximum pruritis). | Up to 168 days after treatment | 
| CM symptom score | The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment. | Up to 168 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque Psoriasis, Ixekizumab, Jueyin granules, Randomized controlled trial, Traditional Chinese medicine