PsoriasisNCT04912401

the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis

An observational study of Psoriasis and Etanercept, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 40 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a prospective, open-label, one-arm study. The study aims to assess the efficacy and safety of Etanercept therapy which help guide the clinical practice in real-world settings. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Psoriasis, Etanercept
How many people: 100 participants
Where: 40 sitesChina
Study dates: 4 Dec 2020to 4 Dec 2025
Phase: Observational
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 75 years
All sexes
Adult, Older adult

Study population: Patients with moderate to severe psoriasis (PASI>3) and bio-naive

Who may be able to join

1.18 to 75 years of age 2.Moderate to severe chronic psoriasis, BSA≥3% 3.Duration of psoriasis≥6 months 4.Patients must be candidate for systemic therapy or phototherapy 5.No contradiction to Etanercept 6.Informed consent must be obtained 7.For female, ß-hCG test is negative and contraception is accepted

Who cannot join

Diagnosis of pustular psoriasis, erythroderma psoriasis or drug-induced psoriasis
Having severe infections, including hepatitis, HIV and tuberculosis
No live vaccines 12 weeks before enrollment, through the study and 1 year after the last dose of Etanercept
Having significant allergies to biological agents
Having the previous experience of biologics
Having a history of malignancy

Show all 9Show fewer

Having contradictions to Etanercept
Refusal of contraception
Having serious or unstable/uncontrolled illnesses

Trial locations and contacts

40 sites in 1 country.

Xiao-yong Man contact

13600516219

manxy@zju.edu.cn

City, postcode or hospital

Sites recruiting now only

40 sites in 1 country

China40 sites, 40 recruiting

2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
XiaoYong Man, MD, 13600516219, manxy@zju.edu.cn
Recruiting
First Affiliated Hospital, Zhejiang Medical University
Hangzhou
Hong Fang, 13588035369, fanghongzy@sina.com
Recruiting
Hang Zhou First People's Hospital
Hangzhou
Jian Chen, 13738080635, janejane819@163.com
Recruiting
Hang Zhou Third People's Hospital
Hangzhou
Yunyun Shan, 13858080025, shanyuanyuan7@163.com
Recruiting
Hospital of dermatology of Xiaoshan
Hangzhou
Kefeng Gu, 13967194658, apf025@163.com
Recruiting
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University
Hangzhou
Kejian Zhu, 13957178822, zhukejiansrrsh@126.com
Recruiting
the People Hospital of Zhejiang Province
Hangzhou
Xiaohong Tao, 13505811700, txhtxh@sina.com
Recruiting
Xiaoshan Hospital
Hangzhou
Huaizhu Yang, 13396711233, Xsyylaoyang1970@163.com
Recruiting
Yuhang Fifth People's Hospital
Hangzhou
Fengming Qi, 18668225609, xiaozhu_314@163.com
Recruiting
Zhejiang Hospital of Traditional Chinese Medicine
Hangzhou
Lili Ma, 13858022185, lilyma163@163.com
Recruiting
Changxing Dermatology Hospital prevention and Treatment
Huzhou
Yueming Xu, 13362293928, cxxuyueming@163.com
Recruiting
Chinese 72 Hospital
Huzhou
Yang Chen, 15606729818, 98cy@163.com
Recruiting
Hospital of dermatology of Zhejiang Province
Huzhou
Xiaobing Yu, 13587211491, kava12345@163.com
Recruiting
Huzhou Central Hospital
Huzhou
Huajie Zhong, 13867287968, zhj0722@sina.com
Recruiting
Huzhou First Hospital
Huzhou
Jianqiang Yang, 13587229333, yjq@zjhu.edu.cn
Recruiting
the People Hospital of Changxing
Huzhou
Mingxing Xie, 13185279302, xiemingxing2004@163.com
Recruiting
Jiaxing First Hospital
Jiaxing
Wenhao Yin, 13957323606, whyin69@sina.com
Recruiting
Rongjun Hospital of Zhejiang Province
Jiaxing
Chunhua Zhao, 13957337520, 40392879@qq.com
Recruiting
Tongxiang Dermatology Hospital prevention and Treatment
Jiaxing
Manping Wu, 13819399780, 770760529@qq.com
Recruiting
Hospital of dermatology of Yiwu
Jinhua
Yongping Xu, 13857979161, 1375750229@qq.com
Recruiting
Jinhua Central Hospital
Jinhua
Meiyan Wang, 13757984755, wangmeiyan600@sina.com
Recruiting
Jinhua Fifth Hospital
Jinhua
Dongmei Liu, 13335988881, ldm200370@126.com
Recruiting
the People Hospital of Dongyang
Jinhua
Fuming Zhang, 13758968877, jhzhangfuming@163.com
Recruiting
Lishui Central Hospital
Lishui
Huan Chen, 13905881161, 345158746@qq.com
Recruiting
the People Hospital of Lishui
Lishui
Haiming Ning, 18957090631, 57228042@qq.com
Recruiting
Ningbo Chinese Medical Hospital
Ningbo
Zhikai Hu, 15888569177, huzhikai88@126.com
Recruiting
Ningbo First Hospital
Ningbo
Bingjiang Lin, 17757461212, linbingj@163.com
Recruiting
Ningbo Sixth Hospital
Ningbo
Zhongxiao Wu, 13806672880, Wzx2033@163.com
Recruiting
Quzhou Chinese Medical Hospital
Quzhou
Zhongliang Xu, 13587126655, qzxzl1968@163.com
Recruiting
the People Hospital of Quzhou
Quzhou
Yan Chen, 13567001923, 41995480@qq.com
Recruiting
Shangyu of Chinese Medical Hospital
Shaoxing
Ke Ye, 15167048086, yeke1975@163.com
Recruiting
Shaoxing Central Hospital
Shaoxing
Jianguo Shen, 15957595921, pjdsjg@yeah.net
Recruiting
Shaoxing Third Hospital
Shaoxing
Ping Xu, 13588507757, Xpzjsxsy@163.com
Recruiting
the People Hospital of Shaoxing
Shaoxing
Hong Chen, 13587321096, chhong68@yeah.net
Recruiting
Taizhou Central Hospital
Taizhou
Jinguang Chen, 13566879800, 373897482@qq.com
Recruiting
Wenling Chinese Medical Hospital
Taizhou
Renjie Ruan, 13858652828, 632495946@qq.com
Recruiting
the First Affiliated Hospital of Wenzhou medical university
Wenzhou
Zhiming Li, 15988718867, 651911747@qq.com
Recruiting
the People Hospital of Cangnan
Wenzhou
Zhengan Ding, 13706878377, 191993635@qq.com
Recruiting
Wenzhou Chinese Medical Hospital
Wenzhou
Dongrui Zhao, 13806613950, 635226547@qq.com
Recruiting
Wenzhou Combinational Hospital of Chinese and Western Medicine
Wenzhou
Zhiwei Chen, 13806837499, 13958903891@163.com
Recruiting

Other trials in China

About this study

Official title: A Prospective Study With Induction Dosing Period Followed by a Maintenance Dosing Period to Evaluate the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis

This is a prospective, open-label, one-arm study. The study aims to assess the efficacy and safety of Etanercept therapy which help guide the clinical practice in real-world settings.

Conditions: Psoriasis, Etanercept
Medical subject headings: Psoriasis

What is being measured

The primary outcome is the main question the study is designed to answer.

The percentage of patients achieving PASI75 at week 12
PASI75: 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores. PASI includes desquamation, erythema, and plaque induration/infiltration.
Measured: 12 weeks

Secondary outcomes (3)

Percentage of patients achieved PASI90 at week 12
PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.
Measured: 12 weeks
Percentage of patients achieved PASI90 at week 24
PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.
Measured: 24 weeks
Percentage of patients achieved PASI90 at week 36
PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.
Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 20204 Dec 2025

First posted3 Jun 2021
Study start4 Dec 2020
Primary completion4 Dec 2025 (estimated)
Study completion4 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04912401
Sponsor's protocol ID: 2020-915
Status last verified: Jan 2024
First submitted: 1 Mar 2021
Last updated: 12 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Xiao-yong Man

13600516219

manxy@zju.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study With Induction Dosing Period Followed by a Maintenance Dosing Period to Evaluate the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis
ClinicalTrials.gov ID: NCT04912401
Acronym / sponsor ID: 2020-915
Conditions: Psoriasis, Etanercept
Study type: Observational
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
Study start: 4 Dec 2020 (actual)
Primary completion: 4 Dec 2025 (estimated)
Study completion: 4 Dec 2025 (estimated)
First posted: 3 Jun 2021 (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 is a prospective, open-label, one-arm study. The study aims to assess the efficacy and safety of Etanercept therapy which help guide the clinical practice in real-world settings.

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 to 75 years
Sex: All
Age groups: Adult, Older adult
Study population: Patients with moderate to severe psoriasis (PASI>3) and bio-naive

Key inclusion criteria (1 listed)

1.18 to 75 years of age 2.Moderate to severe chronic psoriasis, BSA≥3% 3.Duration of psoriasis≥6 months 4.Patients must be candidate for systemic therapy or phototherapy 5.No contradiction to Etanercept 6.Informed consent must be obtained 7.For female, ß-hCG test is negative and contraception is accepted

Key exclusion criteria (9 listed)

Diagnosis of pustular psoriasis, erythroderma psoriasis or drug-induced psoriasis
Having severe infections, including hepatitis, HIV and tuberculosis
No live vaccines 12 weeks before enrollment, through the study and 1 year after the last dose of Etanercept
Having significant allergies to biological agents
Having the previous experience of biologics

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

The percentage of patients achieving PASI75 at week 12
Time frame: 12 weeks
PASI75: 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores. PASI includes desquamation, erythema, and plaque induration/infiltration.

3 secondary outcomes

Percentage of patients achieved PASI90 at week 12
Time frame: 12 weeks
Percentage of patients achieved PASI90 at week 24
Time frame: 24 weeks
Percentage of patients achieved PASI90 at week 36
Time frame: 36 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
Individual participant dataSharing planned: No

Related trials for Psoriasis

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis

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.

Xiao-yong Man contact

13600516219

manxy@zju.edu.cn

40 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis and Etanercept, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 40 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 1 inclusion and 9 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 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Xiao-yong Man (13600516219, manxy@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of patients achieving PASI75 at week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04912401.

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 12 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.