Clinical trial NCT06058546: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ).


Eligibility criteria: Inclusion Criteria:

1. Aged 18-65, male or female.
2. The diagnosis of plaque psoriasis vulgaris was in accordance with the western diagnostic criteria
3. Conformed to the TCM syndrome differentiation standard of plaque psoriasis with Blood-heat syndrome.
4. At screening period: 3 ≤PASI≤ 20, 3%≤BSA≤ 10% and sPGA≥2.
5. Willing to participate voluntarily and sign a written informed consent.

Exclusion Criteria:

1. 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.
2. Systemic therapy with non-biological drugs within 4 weeks prior to randomization, including but not limited to systemic corticosteroids, retinoids, methotrexate, and cyclosporine.
3. 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.
4. Topical anti-psoriatic treatment received within 2 weeks prior to randomization, including retinoids, vitamin D3 derivatives, corticosteroids, and others
5. Physical therapy received within the 4 weeks prior to randomization, including phototherapy (such as UVB, PUVA), combination phototherapy, and balneotherapy.
6. 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.
7. 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.
8. 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.
9. Participation in other clinical trials and received investigational drugs within 1 month prior to screening.
10. Patients with hypersensitivity to the investigational drug components.
11. Patients had a history of smoking, alcohol, drug abuse.
12. 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
13. 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.

Primary outcomes:
measure: PASI 75
timeFrame: Baseline to days 84.
Secondary outcomes:
measure: PASI75
timeFrame: Baseline to days 28、56.
measure: PASI50、90
timeFrame: Baseline to days 28、56、84.
measure: Change value and percentage change in PASI score
timeFrame: Baseline to days 84.
measure: Proportion of subjects achieving sPGA=0 or 1
timeFrame: Baseline to days 28、56、84.
measure: Proportion of subjects achieving an improvement of ≥2 points in sPGA
timeFrame: Baseline to days 28、56、84.
measure: Change value and percentage change in BSA affected by psoriasis
timeFrame: Baseline to days 28、56、84.
measure: Change value and percentage change in NRS for skin itching
timeFrame: Baseline to days 28、56、84.
measure: Change value and percentage change in DLQI score
timeFrame: Baseline to days 28、56、84.
measure: Proportion of subjects achieving DLQI=0-1
timeFrame: Baseline to days 28、56、84.
measure: Change value and percentage change in Traditional Chinese Medicine Syndrome score
timeFrame: Baseline to days 28、56、84.
measure: Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome
timeFrame: Baseline to days 28、56、84.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing traditional Chinese medicine hospital affiliated to Capital Medical University
city: Changchun
country: China
facility: Affiliated Hospital of Changchun University of Traditional Chinese Medicine
city: Changsha
country: China
facility: The First Affiliated Hospital of Hunan University of Chinese Medicine
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
city: Jinan
country: China
facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine
city: Kunming
country: China
facility: Yunnan Provincial Hospital of Traditional Chinese Medicine
city: Nanyang
country: China
facility: Nanyang First People's Hospital
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
city: Tianjin
country: China
facility: Affiliated Hospital of Tianjin Institute of Traditional Chinese Medicine
city: Wenzhou
country: China
facility: First affiliated hospital of Wenzhou medical university
city: Xiamen
country: China
facility: The Second Affiliated Hospital of Xiamen Medical College
city: Xingtai
country: China
facility: Xingtai people's hospital
Study officials:
References: