Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

NCT06058546 | Recruiting Phase 2

• 1 other identifier: TSL-TCM-JWHBW-II
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 12

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 ).

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• PASI 75

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

  Baseline to days 84.

Secondary Outcomes (11)

• PASI75

  Baseline to days 28、56.

• PASI50、90

  Baseline to days 28、56、84.

• Change value and percentage change in PASI score

  Baseline to days 84.

• Proportion of subjects achieving sPGA=0 or 1

  Baseline to days 28、56、84.

• Proportion of subjects achieving an improvement of ≥2 points in sPGA

  Baseline to days 28、56、84.

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

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

Drug: Jiuweihuaban Pill placebo

Low dose group

EXPERIMENTAL

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

Drug: low dose Jiuweihuaban Pill

High dose group

EXPERIMENTAL

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

Drug: high dose Jiuweihuaban Pill

Interventions

Jiuweihuaban Pill placebo DRUG

Jiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks.

Also known as: Placebo group

Placebo group

low dose Jiuweihuaban Pill DRUG

Low dose Jiuweihuaban pill 1 bag(3 g placebo per bag and 9 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.

Also known as: Low dose group

Low dose group

high dose Jiuweihuaban Pill DRUG

High dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.

Also known as: High dose group

High dose group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (12)

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

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Rui Liu

CONTACT

022-86343626; liurui2@tasly.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: November 23, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 3, 2024

Record last verified: 2024-08

Locations

CN (12)