NCT06058546Not yet recruitingPhase 2
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 ).
Tasly Pharmaceutical Group Co., Ltd12 sites in 1 country180 target enrollmentStarted: October 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 180
- Locations
- 12
- Primary Endpoint
- PASI 75
Study Overview
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 ).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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≥
- •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.
Arms & Interventions
Placebo group
Placebo Comparator
Jiuweihuaban Pill placebo, 1 bag each time, p.o. , tid
Intervention: Jiuweihuaban Pill placebo (Drug)
Low dose group
Experimental
Jiuweihuaban Pill , 1 bag each time, p.o. , tid
Intervention: low dose Jiuweihuaban Pill (Drug)
High dose group
Experimental
Jiuweihuaban Pill , 1 bag each time, p.o. , tid
Intervention: high dose Jiuweihuaban Pill (Drug)
Outcomes
Primary Outcomes
PASI 75
Time Frame: Baseline to days 84.
Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days84.
Secondary Outcomes
- PASI75(Baseline to days 28、56.)
- Proportion of subjects achieving sPGA=0 or 1(Baseline to days 28、56、84.)
- Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome(Baseline to days 28、56、84.)
- Change value and percentage change in PASI score(Baseline to days 84.)
- PASI50、90(Baseline to days 28、56、84.)
- Change value and percentage change in BSA affected by psoriasis(Baseline to days 28、56、84.)
- Change value and percentage change in NRS for skin itching(Baseline to days 28、56、84.)
- Change value and percentage change in Traditional Chinese Medicine Syndrome score(Baseline to days 28、56、84.)
- Proportion of subjects achieving an improvement of ≥2 points in sPGA(Baseline to days 28、56、84.)
- Change value and percentage change in DLQI score(Baseline to days 28、56、84.)
- Proportion of subjects achieving DLQI=0-1(Baseline to days 28、56、84.)
Investigators
Study Sites (12)
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