A Clinical Study to Evaluate the Efficacy and Safety of Subcutaneous JS005 Injection in the Treatment of Adults With Moderate to Severe Chronic Plaque Psoriasis

Phase 3

Active, not recruiting

• Conditions: Moderate to Severe Chronic Plaque Psoriasis
• Interventions: Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)

• Registration Number: NCT05975268
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Brief Summary

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of JS005 in 702 adult patients with moderate-to-severe chronic plaque psoriasis

Detailed Description

The study consisted of four periods: screening period (up to 4 weeks), induction period (12 weeks), maintenance period (40 weeks) and follow-up period (8 weeks). This study planned to recruit 702 subjects, who were randomized into JS005 300mg group (234 subjects), JS005 150mg group (234 subjects) and placebo group (234 subjects) at a ratio of 1:1:1, and were stratified by whether they had previsouly received biologic treatments (continuous biologic treatment for ≥3 months at recommended doses or intolerance for safety reasons) and body weight (≥70 kg or \< 70 kg).

Study Timeline

• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-07-27
• Study First Posted: 2023-08-03
• Study Start: 2023-08-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-08-18
• Study Completion: 2025-10-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 747

Inclusion Criteria

1. Subjects voluntarily particpate in this clinical study and sign the informed consent form.
2. Male and female patients aged 18-75 years at the time of screening (both inclusive).
3. Fertile female subjects must be willing to use a highly effective contraceptive method during the study period and 20 weeks (expected 5 half-lives) after the last study drug administration and have a negative pregnancy test during the screening period and prior to randomization.

Exclusion Criteria

1. Pregnant and lactating women.
2. A history of inflammatory bowel disease or other conditions with a high risk of perforation (e.g., severe gastrointestinal ulcers, etc.) or with other active autoimmune diseases (e.g., systemic lupus erythematosus, Sarcoidosis, etc.).
3. Have a type of psoriasis other than chronic plaque psoriasis (e.g., pustular, erythrodermic, and guttate psoriasis), drug-induced psoriasis, or have an active inflammatory skin disease other than psoriasis
4. Use of phototherapy, including but not limited to ultraviolet A phototherapy (with or without psoralens), ultraviolet B phototherapy, or excimer laser within 4 weeks prior to randomization. Subjects are unwilling to avoid excessive sunlight exposure within 4 weeks prior to randomization and during the study period;
5. A (current) history of systemic infection or serious infection requiring hospitalization and/or intravenous anti-infective therapy (e.g., antibiotics, antifungal agents, antiviral agents) within 12 weeks prior to randomization; a history of any active infection, other than common upper respiratory infections, within 2 weeks prior to randomization;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JS005 300mg (recombinant humanized monoclonal antibody against IL-17A)	JS005 (recombinant humanized monoclonal antibody against IL-17A)	-
Placebo	JS005 (recombinant humanized monoclonal antibody against IL-17A)	-
JS005 150mg (recombinant humanized monoclonal antibody against IL-17A)	JS005 (recombinant humanized monoclonal antibody against IL-17A)	-

Primary Outcome Measures

Name	Time	Method
Change in PASI 90	From week 0 to week 12	The proportion of patients who achieved at least 90% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12
Change in sPGA	From week 0 to week 12	The proportion of patients who achieved a static physician Comprehensive Assessment (sPGA) score of 0 or 1 at week 12.

Secondary Outcome Measures

Name	Time	Method
Patients achieving PASI 100 at Week 12	From week 0 to week 12	The proportion of patients who achieved at least 100% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12
Proportion of subjects with a DLQI score of 0/1 at week 12	From week 0 to week 12	The proportion of patients who with a DLQI score at least 0/1 at week 12
Time to sPGA 0/1 response	From week 0 to week 12	Time to sPGA 0/1 response within 12 weeks
Time to PASI 75/90 response	From week 0 to week 12	Time to PASI 75/90 response within 12 weeks
Patients achieving PASI 75 at Week 12	From week 0 to week 12	The proportion of patients who achieved at least 75% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12
Proportion of subjects with a sPGA score of 0 at week 12	From week 0 to week 12	The proportion of patients who achieved at least 0 at week 12
Patients achieving PASI 75 at Week 52	From week 0 to week 52	Proportion of participants with a PASI score improvement of at least 75% (PASI 75) from baseline at week 52
Patients achieving PASI 100 at Week 52	From week 0 to week 52	Proportion of participants with a PASI score improvement of at least 100 from baseline (PASI 100) at week 52
Patients achieving PASI 90 at Week 52	From week 0 to week 52	Proportion of participants with a PASI score improvement of at least 90 (PASI 90) from baseline at week 52

Trial Locations

Locations (63)

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

The Second Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Tongren Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Ningbo Huamei Hospital, University of Chinese Academy of Sciences; 🇨🇳 Beijing, Beijing, China

Beijing LuHe Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, China

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