Oral Chinese Herbal Medicine Formula (Gu Ben Hua Yu Fang) Concurrent With Secukinumab for Severe Plaque Psoriasis
Overview
- Phase
- Early Phase 1
- Intervention
- Gu Ben Hua Yu Fang decoction (Chinese herbal medicine)
- Conditions
- Psoriasis
- Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Median time to relapse
- Last Updated
- 5 years ago
Overview
Brief Summary
The aim of this study is to determine whether oral Chinese herbal medicine in combination secukinumab is effective and safe in the treatment of severe psoriasis.
Detailed Description
The aim of this study is to determine whether oral Chinese herbal medicine in combination with secukinumab is effective and safe in the treatment of severe psoriasis. Eligible participants will be treated with oral Chinese herbal medicine and secukinumab concurrently. No controlled group will be set up in this trial. The primary outcome is time to relapse. Secondary outcomes include Psoriasis Area and Severity Index (PASI) 75/90, PASI score reduction rate, physician's global assessment (PGA) score, body surface area (BSA) score, visual analogue scale (VAS) score, dermatology life quality index (QLQI) and Skindex 16.
Investigators
Chuanjian Lu
Professor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility Criteria
Inclusion Criteria
- •Psoriasis Area and Severity Index (PASI) score≥10
- •Meet the requirement of using secukinumab; without the history of inflammatory bowel disease (IBD)
- •Written/signed informed consent
Exclusion Criteria
- •Unsuitable for the treatment of secukinumab
Arms & Interventions
Chinese herbal medicine in combination with secukinumab
Oral Chinese herbal medicine (Gu Ben Hua Yu Fang decoction) and secukinumab will be used concurrently. The treatment duration for both secukinumab and oral Chinese herbal medicine is up to 16 weeks. Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg). Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice a day. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection.
Intervention: Gu Ben Hua Yu Fang decoction (Chinese herbal medicine)
Chinese herbal medicine in combination with secukinumab
Oral Chinese herbal medicine (Gu Ben Hua Yu Fang decoction) and secukinumab will be used concurrently. The treatment duration for both secukinumab and oral Chinese herbal medicine is up to 16 weeks. Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg). Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice a day. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection.
Intervention: Secukinumab Auto-Injector [Cosentyx]
Outcomes
Primary Outcomes
Median time to relapse
Time Frame: Through study completion, an average of 1 year
Median time to relapse is a time interval. The time interval will be recorded between the end of treatment and the occurrence of relapse. Relapse was defined as loss of \> 50% of maximum Psoriasis Area and Severity Index (PASI) improvement compared with pretreatment baseline.
Secondary Outcomes
- Psoriasis Area and Severity Index (PASI) score(Assessment will be conducted at week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year)
- PASI-75(16 weeks after treatment)
- PASI-90(16 weeks after treatment)
- Physician's global assessment (PGA) score(Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.)
- Pruritus Scores on the Visual Analogue Scale(Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.)
- patients' attitudes, expectation and experience(Interview will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).)
- BSA(Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.)
- Dermatology Life Quality Index (DLQI)(Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).)
- Skindex16(Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).)