NCT04414605

Oral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis

Oral Chinese Herbal Medicine Formula (Gu Ben Hua Yu Fang) Concurrent With Secukinumab for Severe Plaque Psoriasis

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Gu Ben Hua Yu Fang decoction (Chinese herbal medicine)	Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice daily. 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.
DRUG	Secukinumab Auto-Injector [Cosentyx]	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).

Timeline

• Start date: 2020-06-04
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-06-04
• Last updated: 2021-03-02

Locations

1 site across 1 country: China