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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04912401
• Other study ID #: 2020-915
• Status: Recruiting
• Start date: December 4, 2020
• Est. completion date: December 4, 2025

Study information

• Verified date: January 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiao-yong Man
• Phone: 13600516219
• Email: manxy[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 4, 2025
• Est. primary completion date: December 4, 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Diagnosis of pustular psoriasis, erythroderma psoriasis or drug-induced psoriasis

2. Having severe infections, including hepatitis, HIV and tuberculosis

3. No live vaccines 12 weeks before enrollment, through the study and 1 year after the last dose of Etanercept

4. Having significant allergies to biological agents

5. Having the previous experience of biologics

6. Having a history of malignancy

7. Having contradictions to Etanercept

8. Refusal of contraception

9. Having serious or unstable/uncontrolled illnesses

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	First Affiliated Hospital, Zhejiang Medical University	Hangzhou
China	Hang Zhou First People's Hospital	Hangzhou
China	Hang Zhou Third People's Hospital	Hangzhou
China	Hospital of dermatology of Xiaoshan	Hangzhou
China	Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University	Hangzhou
China	the People Hospital of Zhejiang Province	Hangzhou
China	Xiaoshan Hospital	Hangzhou
China	Yuhang Fifth People's Hospital	Hangzhou
China	Zhejiang Hospital of Traditional Chinese Medicine	Hangzhou
China	Changxing Dermatology Hospital prevention and Treatment	Huzhou
China	Chinese 72 Hospital	Huzhou
China	Hospital of dermatology of Zhejiang Province	Huzhou
China	Huzhou Central Hospital	Huzhou
China	Huzhou First Hospital	Huzhou
China	the People Hospital of Changxing	Huzhou
China	Jiaxing First Hospital	Jiaxing
China	Rongjun Hospital of Zhejiang Province	Jiaxing
China	Tongxiang Dermatology Hospital prevention and Treatment	Jiaxing
China	Hospital of dermatology of Yiwu	Jinhua
China	Jinhua Central Hospital	Jinhua
China	Jinhua Fifth Hospital	Jinhua
China	the People Hospital of Dongyang	Jinhua
China	Lishui Central Hospital	Lishui
China	the People Hospital of Lishui	Lishui
China	Ningbo Chinese Medical Hospital	Ningbo
China	Ningbo First Hospital	Ningbo
China	Ningbo Sixth Hospital	Ningbo
China	Quzhou Chinese Medical Hospital	Quzhou
China	the People Hospital of Quzhou	Quzhou
China	Shangyu of Chinese Medical Hospital	Shaoxing
China	Shaoxing Central Hospital	Shaoxing
China	Shaoxing Third Hospital	Shaoxing
China	the People Hospital of Shaoxing	Shaoxing
China	Taizhou Central Hospital	Taizhou
China	Wenling Chinese Medical Hospital	Taizhou
China	the First Affiliated Hospital of Wenzhou medical university	Wenzhou
China	the People Hospital of Cangnan	Wenzhou
China	Wenzhou Chinese Medical Hospital	Wenzhou
China	Wenzhou Combinational Hospital of Chinese and Western Medicine	Wenzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	Percentage of patients achieved PASI90 at week 12	PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.	12 weeks
Secondary	Percentage of patients achieved PASI90 at week 24	PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.	24 weeks
Secondary	Percentage of patients achieved PASI90 at week 36	PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.	36 weeks