Oral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04414605
• Other study ID #: BF2020-068-02
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 4, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2020
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Chuanjian Lu, PhD
• Phone: +8620-81887233
• Email: luchuanjian888[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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.
• 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).

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median time to relapse	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.	Through study completion, an average of 1 year
Secondary	Psoriasis Area and Severity Index (PASI) score	The improvement in Psoriasis Area and Severity Index (PASI) score from baseline after treatment; the scale scores ranged from 0-72. The higher the scores are, the more severe the patients suffer	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
Secondary	PASI-75	The proportion of patients who achieve at least 75% improvement in PASI score from baseline.	16 weeks after treatment
Secondary	PASI-90	The proportion of patients who achieve at least 90% improvement in PASI score from baseline.	16 weeks after treatment
Secondary	Physician's global assessment (PGA) score	Physician's global assessment for the condition	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.
Secondary	Pruritus Scores on the Visual Analogue Scale	Pruritus will be assessed using the Visual Analogue Scales; The Scale scores ranged from 0-10; the higher the scores are, the more itching the patients suffer.	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.
Secondary	BSA	the Body Surface Area	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.
Secondary	Dermatology Life Quality Index (DLQI)	Questionnaire for disease-specific quality of life	Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
Secondary	Skindex16	Questionnaire for disease-specific quality of life	Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
Secondary	patients' attitudes, expectation and experience	Semi-structured individual interview will be conducted to explore patients' understanding and expectation for the combination therapy used in this study. Patients' experience of using the combination therapy will be recorded as well.	Interview will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).