NCT05975268|CompletedPhase 3

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

A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Subcutaneous JS005 Injection in the Treatment of Adults With Moderate to Severe Chronic Plaque Psoriasis

Shanghai Junshi Bioscience Co., Ltd.ClinicalTrials.gov

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1 other identifier

JS005-005-III-PsO

Study Type

interventional

Target

747

Locations

1 country

Sites

Timeline

RegisteredAug 2023

StartedAug 2023

CompletionSep 2025

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

747

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Aug 2023

Geographic Reach

1 country

63 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

July 27, 2023

Completed

7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed

25 days until next milestone

Study Start

First participant enrolled

August 28, 2023

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed

14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2025

Completed

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

July 27, 2023

Last Update Submit

December 8, 2025

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (9)

Patients achieving PASI 75 at Week 12
From week 0 to week 12
Patients achieving PASI 100 at Week 12
From week 0 to week 12
Proportion of subjects with a sPGA score of 0 at week 12
From week 0 to week 12
Proportion of subjects with a DLQI score of 0/1 at week 12
From week 0 to week 12
Patients achieving PASI 75 at Week 52
From week 0 to week 52
+4 more secondary outcomes

Study Arms (3)

JS005 150mg (recombinant humanized monoclonal antibody against IL-17A)

EXPERIMENTAL

Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)

JS005 300mg (recombinant humanized monoclonal antibody against IL-17A)

EXPERIMENTAL

Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)

Placebo

PLACEBO COMPARATOR

Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)

Interventions

JS005 (recombinant humanized monoclonal antibody against IL-17A)BIOLOGICAL

JS005/placebo

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

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects voluntarily particpate in this clinical study and sign the informed consent form.
Male and female patients aged 18-75 years at the time of screening (both inclusive).
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.

You may not qualify if:

Pregnant and lactating women.
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.).
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
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;
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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Shanghai Junshi Bioscience Co., Ltd.lead

Study Sites (63)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Beijing Friendship Hospital, Capital Medical University