Plaque PsoriasisPhase 2NCT06058546
Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis
A Phase 2 study testing low dose Jiuweihuaban Pill and high dose Jiuweihuaban Pill in people with Plaque Psoriasis, run by Tasly Pharmaceutical Group Co., Ltd at 12 sites in China.
Trial 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 ). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- low dose Jiuweihuaban Pill and high dose Jiuweihuaban Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 12 sitesChina
- Study dates
- 23 Nov 2023to Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Beijing traditional Chinese medicine hospital affiliated to Capital Medical University
Beijing
Dongmei Zhou, 13811201580, 52176857@163.com
- Recruiting
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun
Ying Sun, 13624300207, 30636379@qq.com
- Recruiting
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha
Jianyuan Xi, 15974172722, syfzb9068@sina.cn
- Recruiting
Chengdu Second People's Hospital
Chengdu
Yanyan Feng, 13999163793, Yolanda20220918@163.com
- Recruiting
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan
Chiu Isabella, 13210516416, zhaoyingszy@163.com
- Recruiting
Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming
Xiaoyong Ouyang, 13708446568, oyxy68@126.com
- Recruiting
Nanyang First People's Hospital
Nanyang
Rixin Chen, 13849795170, pfkgcpby@163.com
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang
Long Geng, 13709853622, genglong99@126.com
- Recruiting
Affiliated Hospital of Tianjin Institute of Traditional Chinese Medicine
Tianjin
Litao Zhang, 18602228122, zhanglitao@medmail.com.cn
- Recruiting
First affiliated hospital of Wenzhou medical university
Wenzhou
Zhiming Li, 15988718867, zhi-mingli@163.com
- Recruiting
The Second Affiliated Hospital of Xiamen Medical College
Xiamen
mingkai Ji, 13075959049, Mingkai_ji@163.com
- Recruiting
Xingtai people's hospital
Xingtai
Fang Cheng, 18931912286, 18931912286@163.com
About this study
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 ).
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
- Being tested
- Jiuweihuaban Pill placebo, low dose Jiuweihuaban Pill, high dose Jiuweihuaban Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jiuweihuaban Pill placeboDrug
Also called Placebo group
Jiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks.
low dose Jiuweihuaban PillDrug
Also called Low dose group
Low dose Jiuweihuaban pill 1 bag(3 g placebo per bag and 9 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.
high dose Jiuweihuaban PillDrug
Also called High dose group
High dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Jiuweihuaban Pill placebo, 1 bag each time, p.o. , tid Receives: Drug: Jiuweihuaban Pill placebo |
| Low dose group | Experimental | Jiuweihuaban Pill , 1 bag each time, p.o. , tid Receives: Drug: low dose Jiuweihuaban Pill |
| High dose group | Experimental | Jiuweihuaban Pill , 1 bag each time, p.o. , tid Receives: Drug: high dose Jiuweihuaban Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI 75
Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days84.
Measured: Baseline to days 84.
Secondary outcomes (11)
PASI75
Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days 28、56.
Measured: Baseline to days 28、56.
PASI50、90
Proportion of subjects achieving an improvement of ≥50% and ≥90% in Psoriasis Area and Severity Index (PASI50, PASI90) from baseline at days 28、56、84.
Measured: Baseline to days 28、56、84.
Change value and percentage change in PASI score
Change value and percentage change in PASI score from baseline at days 84.The PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, corresponding to maximal signs of psoriasis.
Measured: Baseline to days 84.
Proportion of subjects achieving sPGA=0 or 1
Proportion of subjects achieving clear (score of 0) or almost clear (score of 1) in static Physician Global Assessment (sPGA=0 or 1) at Weeks 4, 8, and 12.
Measured: Baseline to days 28、56、84.
Proportion of subjects achieving an improvement of ≥2 points in sPGA
Proportion of subjects achieving an improvement of ≥2 points in static Physician Global Assessment from baseline at days 28、56、84.
Measured: Baseline to days 28、56、84.
Change value and percentage change in BSA affected by psoriasis
Change value and percentage change in Body Surface Area (BSA) affected by psoriasis from baseline at days 28、56、84.
Measured: Baseline to days 28、56、84.
Change value and percentage change in NRS for skin itching
Change value and percentage change in Numeric Rating Scale (NRS) for skin itching from baseline at days 28、56、84. The NRS scores can range from 0,corresponding to no itching symptom，up to a maximum of 10,corresponing to the most severe itching .
Measured: Baseline to days 28、56、84.
Change value and percentage change in DLQI score
Change value and percentage change in Dermatology Life Quality Index (DLQI) score from baseline at days 28、56、84. The DLQI scores can range from 0 to 30.The higher the score, the worse the quality of life.
Measured: Baseline to days 28、56、84.
Proportion of subjects achieving DLQI=0-1
Proportion of subjects achieving a DLQI score of 0-1 (DLQI=0-1) at days 28、56、84.The DLQI scores can range from 0 to 30.The higher the score, the worse the quality of life.
Measured: Baseline to days 28、56、84.
Change value and percentage change in Traditional Chinese Medicine Syndrome score
Change value and percentage change in Traditional Chinese Medicine Syndrome score from baseline at days 28、56、84.The Traditional Chinese Medicine Syndrome scores can range from 0 to 27.The higher the score, the more severe psoriasis.
Measured: Baseline to days 28、56、84.
Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome
Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome at days 28、56、84.
Measured: Baseline to days 28、56、84.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start23 Nov 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058546
- Sponsor's protocol ID
- TSL-TCM-JWHBW-II
- Status last verified
- Aug 2024
- First submitted
- 21 Sep 2023
- Last updated
- 3 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ).
- ClinicalTrials.gov ID
- NCT06058546
- Acronym / sponsor ID
- TSL-TCM-JWHBW-II
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Jiuweihuaban Pill placeboJiuweihuaban Pill placebo, 1 bag each time, p.o. , tid |
| Low dose group | Experimental | Drug: low dose Jiuweihuaban PillJiuweihuaban Pill , 1 bag each time, p.o. , tid |
| High dose group | Experimental | Drug: high dose Jiuweihuaban PillJiuweihuaban Pill , 1 bag each time, p.o. , tid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jiuweihuaban Pill placeboAlso: Placebo groupJiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks. | Drug | Placebo group |
| low dose Jiuweihuaban PillAlso: Low dose groupLow dose Jiuweihuaban pill 1 bag(3 g placebo per bag and 9 g Jiuweihuaban pill ),p.o.,tid,for 12weeks. | Drug | Low dose group |
| high dose Jiuweihuaban PillAlso: High dose groupHigh dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks. | Drug | High dose group |
Primary outcome
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.
11 secondary outcomes
PASI75
Time frame: Baseline to days 28、56.
PASI50、90
Time frame: Baseline to days 28、56、84.
Change value and percentage change in PASI score
Time frame: Baseline to days 84.
Proportion of subjects achieving sPGA=0 or 1
Time frame: Baseline to days 28、56、84.
Proportion of subjects achieving an improvement of ≥2 points in sPGA
Time frame: Baseline to days 28、56、84.
Change value and percentage change in BSA affected by psoriasis
Time frame: Baseline to days 28、56、84.
Change value and percentage change in NRS for skin itching
Time frame: Baseline to days 28、56、84.
Change value and percentage change in DLQI score
Time frame: Baseline to days 28、56、84.
Proportion of subjects achieving DLQI=0-1
Time frame: Baseline to days 28、56、84.
Change value and percentage change in Traditional Chinese Medicine Syndrome score
Time frame: Baseline to days 28、56、84.
Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome
Time frame: Baseline to days 28、56、84.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing low dose Jiuweihuaban Pill and high dose Jiuweihuaban Pill in people with Plaque Psoriasis, run by Tasly Pharmaceutical Group Co., Ltd at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Liu (022-86343626, liurui2@tasly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PASI 75 (time frame: Baseline to days 84.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.