Oral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status and phase: Unknown; Early Phase 1

Conditions: Psoriasis

Treatments: Drug: Gu Ben Hua Yu Fang decoction (Chinese herbal medicine); Drug: Secukinumab Auto-Injector [Cosentyx]

Study type: Interventional

Funder types: Other

Identifiers

NCT04414605

BF2020-068-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Psoriasis Area and Severity Index (PASI) score≥10
2. Meet the requirement of using secukinumab; without the history of inflammatory bowel disease (IBD)
3. Written/signed informed consent

Exclusion criteria

1. Unsuitable for the treatment of secukinumab

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Chinese herbal medicine in combination with secukinumab

Experimental group

Description:

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.

Treatment:

Drug: Secukinumab Auto-Injector [Cosentyx]

Drug: Gu Ben Hua Yu Fang decoction (Chinese herbal medicine)