Back to resultsOral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Gu Ben Hua Yu Fang decoction (Chinese herbal medicine)
Secukinumab Auto-Injector [Cosentyx]
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
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:
1. Unsuitable for the treatment of secukinumab
Sites / Locations
- Guangdong Provincial Hospital of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chinese herbal medicine in combination with secukinumab
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
PASI-75
The proportion of patients who achieve at least 75% improvement in PASI score from baseline.
PASI-90
The proportion of patients who achieve at least 90% improvement in PASI score from baseline.
Physician's global assessment (PGA) score
Physician's global assessment for the condition
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.
BSA
the Body Surface Area
Dermatology Life Quality Index (DLQI)
Questionnaire for disease-specific quality of life
Skindex16
Questionnaire for disease-specific quality of life
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.
Full Information
NCT ID
NCT04414605
First Posted
May 11, 2020
Last Updated
February 28, 2021
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04414605
Brief Title
Oral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis
Official Title
Oral Chinese Herbal Medicine Formula (Gu Ben Hua Yu Fang) Concurrent With Secukinumab for Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chinese herbal medicine in combination with secukinumab
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Gu Ben Hua Yu Fang decoction (Chinese herbal medicine)
Other Intervention Name(s)
Chinese herbal medicine decoction
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Secukinumab Auto-Injector [Cosentyx]
Other Intervention Name(s)
Cosentyx
Intervention Description
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).
Primary Outcome Measure Information:
Title
Median time to relapse
Description
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.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI) score
Description
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
Time Frame
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
Title
PASI-75
Description
The proportion of patients who achieve at least 75% improvement in PASI score from baseline.
Time Frame
16 weeks after treatment
Title
PASI-90
Description
The proportion of patients who achieve at least 90% improvement in PASI score from baseline.
Time Frame
16 weeks after treatment
Title
Physician's global assessment (PGA) score
Description
Physician's global assessment for the condition
Time Frame
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.
Title
Pruritus Scores on the Visual Analogue Scale
Description
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.
Time Frame
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.
Title
BSA
Description
the Body Surface Area
Time Frame
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.
Title
Dermatology Life Quality Index (DLQI)
Description
Questionnaire for disease-specific quality of life
Time Frame
Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
Title
Skindex16
Description
Questionnaire for disease-specific quality of life
Time Frame
Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
Title
patients' attitudes, expectation and experience
Description
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.
Time Frame
Interview will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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:
1. Unsuitable for the treatment of secukinumab
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuanjian Lu, PhD
Phone
+8620-81887233
Ext
31223
Email
luchuanjian888@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jingjie Yu, PhD
Phone
+8620-81887233
Ext
35934
Email
jingjieyu@gzucm.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuanjian Lu, PhD
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial Hospital of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuanjian Lu, PhD
Phone
(8620)81887233
Ext
31223
Email
luchuanjian888@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Zehuai Wen, PhD
Phone
（86）13903008091
Email
wenzehuai@139.com
First Name & Middle Initial & Last Name & Degree
Chuanjian Lu, PhD
First Name & Middle Initial & Last Name & Degree
Jingjie Yu, PhD
12. IPD Sharing Statement
Learn more about this trial
Oral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis
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