Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

Tasly Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: high dose Jiuweihuaban Pill; Drug: Jiuweihuaban Pill placebo; Drug: low dose Jiuweihuaban Pill

Study type: Interventional

Funder types: Industry

Identifiers

NCT06058546

TSL-TCM-JWHBW-II

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Jiuweihuaban Pill placebo

Low dose group

Experimental group

Description:

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

Treatment:

Drug: low dose Jiuweihuaban Pill

High dose group

Experimental group

Description:

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

Treatment:

Drug: high dose Jiuweihuaban Pill