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Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Jiuweihuaban Pill placebo
low dose Jiuweihuaban Pill
high dose Jiuweihuaban Pill
Sponsored by
Tasly Pharmaceutical Group Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18-65, male or female. The diagnosis of plaque psoriasis vulgaris was in accordance with the western diagnostic criteria Conformed to the TCM syndrome differentiation standard of plaque psoriasis with Blood-heat syndrome. At screening period: 3 ≤PASI≤ 20, 3%≤BSA≤ 10% and sPGA≥2. Willing to participate voluntarily and sign a written informed consent. Exclusion Criteria: Psoriasis caused by drug-induced factors; combined with non-plaque Psoriasis at screening (such as guttate,arthropathica, pustular, erythrodermic and other types of Psoriasis); The skin lesions are exclusively observed in subjects with specific areas such as the face, scalp, nails, skin folds, glans penis, mucous membranes, palms, and soles. Systemic therapy with non-biological drugs within 4 weeks prior to randomization, including but not limited to systemic corticosteroids, retinoids, methotrexate, and cyclosporine. Systemic therapy with biological drugs within 12 weeks or 5 half-lives (whichever is longer) prior to randomization, including but not limited to interleukin antibodies (such as ustekinumab, secukinumab) and tumor necrosis factor-alpha antagonists (such as etanercept, infliximab, adalimumab) in the study. Topical anti-psoriatic treatment received within 2 weeks prior to randomization, including retinoids, vitamin D3 derivatives, corticosteroids, and others Physical therapy received within the 4 weeks prior to randomization, including phototherapy (such as UVB, PUVA), combination phototherapy, and balneotherapy. Systemic anti-infective treatment received within the 4 weeks prior to randomization; presence of recurrent, chronic, or active infection at baseline as determined by the investigator and judged to increase the subject's risk. With a serious, progressive, or uncontrolled disease, including but not limited to a disease of the immune (such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease), endocrine, hematological, urinary, hepatobiliary, and respiratory, nervous, psychiatric, cardiovascular, gastrointestinal, or infectious system, a malignancy. Patients with serum creatinine above the upper limit of normal at screening, with elevated Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) levels ≥ 1.5 times the upper limit of normal. Participation in other clinical trials and received investigational drugs within 1 month prior to screening. Patients with hypersensitivity to the investigational drug components. Patients had a history of smoking, alcohol, drug abuse. Patients (including partners) have plans to become pregnant from 2 weeks before the first dose to 1 month after the last dose and Subjects do not take effective contraceptive measures during this period or during pregnancy or breastfeeding Any other situation that the investigator did not consider suitable for participation in the study, such as other skin problems that hinder the assessment of Psoriasis, potential compliance problems, inability to complete all examinations and evaluations in accordance with the protocol requirements, may pose an uncontrollable risk for participation in the study.

Sites / Locations

  • Beijing traditional Chinese medicine hospital affiliated to Capital Medical University
  • Affiliated Hospital of Changchun University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Hunan University of Chinese Medicine
  • Chengdu Second People's Hospital
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  • Yunnan Provincial Hospital of Traditional Chinese Medicine
  • Nanyang First People's Hospital
  • The First Affiliated Hospital of China Medical University
  • Affiliated Hospital of Tianjin Institute of Traditional Chinese Medicine
  • First affiliated hospital of Wenzhou medical university
  • The Second Affiliated Hospital of Xiamen Medical College
  • Xingtai people's hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo group

Low dose group

High dose group

Arm Description

Jiuweihuaban Pill placebo, 1 bag each time, p.o. , tid

Jiuweihuaban Pill , 1 bag each time, p.o. , tid

Jiuweihuaban Pill , 1 bag each time, p.o. , tid

Outcomes

Primary Outcome Measures

PASI 75
Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days84.

Secondary Outcome Measures

PASI75
Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days 28、56.
PASI50、90
Proportion of subjects achieving an improvement of ≥50% and ≥90% in Psoriasis Area and Severity Index (PASI50, PASI90) from baseline at days 28、56、84.
Change value and percentage change in PASI score
Change value and percentage change in PASI score from baseline at days 84.The PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, corresponding to maximal signs of psoriasis.
Proportion of subjects achieving sPGA=0 or 1
Proportion of subjects achieving clear (score of 0) or almost clear (score of 1) in static Physician Global Assessment (sPGA=0 or 1) at Weeks 4, 8, and 12.
Proportion of subjects achieving an improvement of ≥2 points in sPGA
Proportion of subjects achieving an improvement of ≥2 points in static Physician Global Assessment from baseline at days 28、56、84.
Change value and percentage change in BSA affected by psoriasis
Change value and percentage change in Body Surface Area (BSA) affected by psoriasis from baseline at days 28、56、84.
Change value and percentage change in NRS for skin itching
Change value and percentage change in Numeric Rating Scale (NRS) for skin itching from baseline at days 28、56、84. The NRS scores can range from 0,corresponding to no itching symptom,up to a maximum of 10,corresponing to the most severe itching .
Change value and percentage change in DLQI score
Change value and percentage change in Dermatology Life Quality Index (DLQI) score from baseline at days 28、56、84. The DLQI scores can range from 0 to 30.The higher the score, the worse the quality of life.
Proportion of subjects achieving DLQI=0-1
Proportion of subjects achieving a DLQI score of 0-1 (DLQI=0-1) at days 28、56、84.The DLQI scores can range from 0 to 30.The higher the score, the worse the quality of life.
Change value and percentage change in Traditional Chinese Medicine Syndrome score
Change value and percentage change in Traditional Chinese Medicine Syndrome score from baseline at days 28、56、84.The Traditional Chinese Medicine Syndrome scores can range from 0 to 27.The higher the score, the more severe psoriasis.
Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome
Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome at days 28、56、84.

Full Information

First Posted
September 21, 2023
Last Updated
September 27, 2023
Sponsor
Tasly Pharmaceutical Group Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06058546
Brief Title
Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis
Official Title
A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Clinical Trial of Efficacy and Safety of Jiuweihuaban Pill in the Treatment of Moderate to Severe Plaque Psoriasis(Syndrome of Blood-heat ).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceutical Group Co., Ltd

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
This study will evaluate the efficacy and safety of Jiuweihuaban Pill in the treatment of moderate to severe plaque psoriasis(syndrome of blood-heat ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Jiuweihuaban Pill placebo, 1 bag each time, p.o. , tid
Arm Title
Low dose group
Arm Type
Experimental
Arm Description
Jiuweihuaban Pill , 1 bag each time, p.o. , tid
Arm Title
High dose group
Arm Type
Experimental
Arm Description
Jiuweihuaban Pill , 1 bag each time, p.o. , tid
Intervention Type
Drug
Intervention Name(s)
Jiuweihuaban Pill placebo
Other Intervention Name(s)
Placebo group
Intervention Description
Jiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks.
Intervention Type
Drug
Intervention Name(s)
low dose Jiuweihuaban Pill
Other Intervention Name(s)
Low dose group
Intervention Description
Low dose Jiuweihuaban pill 1 bag(3 g placebo per bag and 9 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.
Intervention Type
Drug
Intervention Name(s)
high dose Jiuweihuaban Pill
Other Intervention Name(s)
High dose group
Intervention Description
High dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.
Primary Outcome Measure Information:
Title
PASI 75
Description
Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days84.
Time Frame
Baseline to days 84.
Secondary Outcome Measure Information:
Title
PASI75
Description
Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days 28、56.
Time Frame
Baseline to days 28、56.
Title
PASI50、90
Description
Proportion of subjects achieving an improvement of ≥50% and ≥90% in Psoriasis Area and Severity Index (PASI50, PASI90) from baseline at days 28、56、84.
Time Frame
Baseline to days 28、56、84.
Title
Change value and percentage change in PASI score
Description
Change value and percentage change in PASI score from baseline at days 84.The PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, corresponding to maximal signs of psoriasis.
Time Frame
Baseline to days 84.
Title
Proportion of subjects achieving sPGA=0 or 1
Description
Proportion of subjects achieving clear (score of 0) or almost clear (score of 1) in static Physician Global Assessment (sPGA=0 or 1) at Weeks 4, 8, and 12.
Time Frame
Baseline to days 28、56、84.
Title
Proportion of subjects achieving an improvement of ≥2 points in sPGA
Description
Proportion of subjects achieving an improvement of ≥2 points in static Physician Global Assessment from baseline at days 28、56、84.
Time Frame
Baseline to days 28、56、84.
Title
Change value and percentage change in BSA affected by psoriasis
Description
Change value and percentage change in Body Surface Area (BSA) affected by psoriasis from baseline at days 28、56、84.
Time Frame
Baseline to days 28、56、84.
Title
Change value and percentage change in NRS for skin itching
Description
Change value and percentage change in Numeric Rating Scale (NRS) for skin itching from baseline at days 28、56、84. The NRS scores can range from 0,corresponding to no itching symptom,up to a maximum of 10,corresponing to the most severe itching .
Time Frame
Baseline to days 28、56、84.
Title
Change value and percentage change in DLQI score
Description
Change value and percentage change in Dermatology Life Quality Index (DLQI) score from baseline at days 28、56、84. The DLQI scores can range from 0 to 30.The higher the score, the worse the quality of life.
Time Frame
Baseline to days 28、56、84.
Title
Proportion of subjects achieving DLQI=0-1
Description
Proportion of subjects achieving a DLQI score of 0-1 (DLQI=0-1) at days 28、56、84.The DLQI scores can range from 0 to 30.The higher the score, the worse the quality of life.
Time Frame
Baseline to days 28、56、84.
Title
Change value and percentage change in Traditional Chinese Medicine Syndrome score
Description
Change value and percentage change in Traditional Chinese Medicine Syndrome score from baseline at days 28、56、84.The Traditional Chinese Medicine Syndrome scores can range from 0 to 27.The higher the score, the more severe psoriasis.
Time Frame
Baseline to days 28、56、84.
Title
Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome
Description
Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome at days 28、56、84.
Time Frame
Baseline to days 28、56、84.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-65, male or female. The diagnosis of plaque psoriasis vulgaris was in accordance with the western diagnostic criteria Conformed to the TCM syndrome differentiation standard of plaque psoriasis with Blood-heat syndrome. At screening period: 3 ≤PASI≤ 20, 3%≤BSA≤ 10% and sPGA≥2. Willing to participate voluntarily and sign a written informed consent. Exclusion Criteria: Psoriasis caused by drug-induced factors; combined with non-plaque Psoriasis at screening (such as guttate,arthropathica, pustular, erythrodermic and other types of Psoriasis); The skin lesions are exclusively observed in subjects with specific areas such as the face, scalp, nails, skin folds, glans penis, mucous membranes, palms, and soles. Systemic therapy with non-biological drugs within 4 weeks prior to randomization, including but not limited to systemic corticosteroids, retinoids, methotrexate, and cyclosporine. Systemic therapy with biological drugs within 12 weeks or 5 half-lives (whichever is longer) prior to randomization, including but not limited to interleukin antibodies (such as ustekinumab, secukinumab) and tumor necrosis factor-alpha antagonists (such as etanercept, infliximab, adalimumab) in the study. Topical anti-psoriatic treatment received within 2 weeks prior to randomization, including retinoids, vitamin D3 derivatives, corticosteroids, and others Physical therapy received within the 4 weeks prior to randomization, including phototherapy (such as UVB, PUVA), combination phototherapy, and balneotherapy. Systemic anti-infective treatment received within the 4 weeks prior to randomization; presence of recurrent, chronic, or active infection at baseline as determined by the investigator and judged to increase the subject's risk. With a serious, progressive, or uncontrolled disease, including but not limited to a disease of the immune (such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease), endocrine, hematological, urinary, hepatobiliary, and respiratory, nervous, psychiatric, cardiovascular, gastrointestinal, or infectious system, a malignancy. Patients with serum creatinine above the upper limit of normal at screening, with elevated Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) levels ≥ 1.5 times the upper limit of normal. Participation in other clinical trials and received investigational drugs within 1 month prior to screening. Patients with hypersensitivity to the investigational drug components. Patients had a history of smoking, alcohol, drug abuse. Patients (including partners) have plans to become pregnant from 2 weeks before the first dose to 1 month after the last dose and Subjects do not take effective contraceptive measures during this period or during pregnancy or breastfeeding Any other situation that the investigator did not consider suitable for participation in the study, such as other skin problems that hinder the assessment of Psoriasis, potential compliance problems, inability to complete all examinations and evaluations in accordance with the protocol requirements, may pose an uncontrollable risk for participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Liu
Phone
022-86343626
Email
liurui2@tasly.com
Facility Information:
Facility Name
Beijing traditional Chinese medicine hospital affiliated to Capital Medical University
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongmei Zhou
Phone
13811201580
Email
52176857@163.com
Facility Name
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
City
Changchun
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Sun
Phone
13624300207
Email
30636379@qq.com
Facility Name
The First Affiliated Hospital of Hunan University of Chinese Medicine
City
Changsha
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyuan Xi
Phone
15974172722
Email
syfzb9068@sina.cn
Facility Name
Chengdu Second People's Hospital
City
Chengdu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyan Feng
Phone
13999163793
Email
Yolanda20220918@163.com
Facility Name
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiu Isabella
Phone
13210516416
Email
zhaoyingszy@163.com
Facility Name
Yunnan Provincial Hospital of Traditional Chinese Medicine
City
Kunming
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyong Ouyang
Phone
13708446568
Email
oyxy68@126.com
Facility Name
Nanyang First People's Hospital
City
Nanyang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rixin Chen
Phone
13849795170
Email
pfkgcpby@163.com
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Long Geng
Phone
13709853622
Email
genglong99@126.com
Facility Name
Affiliated Hospital of Tianjin Institute of Traditional Chinese Medicine
City
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Litao Zhang
Phone
18602228122
Email
zhanglitao@medmail.com.cn
Facility Name
First affiliated hospital of Wenzhou medical university
City
Wenzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiming Li
Phone
15988718867
Email
zhi-mingli@163.com
Facility Name
The Second Affiliated Hospital of Xiamen Medical College
City
Xiamen
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mingkai Ji
Phone
13075959049
Email
Mingkai_ji@163.com
Facility Name
Xingtai people's hospital
City
Xingtai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Cheng
Phone
18931912286
Email
18931912286@163.com

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

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