Oral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis

February 28, 2021 updated by: Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chuanjian Lu, PhD
        • Sub-Investigator:
          • Jingjie Yu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Chinese herbal medicine decoction
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).
Other Names:
  • Cosentyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psoriasis Area and Severity Index (PASI) score
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
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
PASI-75
Time Frame: 16 weeks after treatment
The proportion of patients who achieve at least 75% improvement in PASI score from baseline.
16 weeks after treatment
PASI-90
Time Frame: 16 weeks after treatment
The proportion of patients who achieve at least 90% improvement in PASI score from baseline.
16 weeks after treatment
Physician's global assessment (PGA) score
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.
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.
Pruritus Scores on the Visual Analogue Scale
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.
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.
BSA
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.
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.
Dermatology Life Quality Index (DLQI)
Time Frame: Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
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).
Skindex16
Time Frame: Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
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).
patients' attitudes, expectation and experience
Time Frame: Interview will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 31, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 28, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BF2020-068-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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