Evaluating Jiuweihuaban Pill for treating plaque psoriasis

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 ).

This study is testing if the Jiuweihuaban Pill can help people with moderate to severe plaque psoriasis feel better compared to standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tasly Pharmaceutical Group Co., Ltd (Industry-sponsored)
• Drugs / interventions: ustekinumab, secukinumab, infliximab, adalimumab, methotrexate
• Locations: 12 sites (Beijing and 11 other locations)
• Trial ID: NCT06058546 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of the Jiuweihuaban Pill in patients with moderate to severe plaque psoriasis characterized by blood-heat syndrome. Participants will receive either a placebo, a low dose, or a high dose of the Jiuweihuaban Pill. The study aims to determine how well this treatment works compared to standard care. Patients will be monitored for improvements in their psoriasis symptoms and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of moderate to severe plaque psoriasis and blood-heat syndrome.

Not a fit: Patients with psoriasis caused by drug-induced factors or those with other types of psoriasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from plaque psoriasis.

How similar studies have performed: While this approach is based on traditional Chinese medicine, similar studies have shown promise in treating psoriasis with alternative therapies, but this specific treatment is relatively novel.

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.

Where this trial is running

Beijing and 11 other locations

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

Study contacts

• Study coordinator: Rui Liu

Conditions Plaque Psoriasis