Moderate to Severe Chronic Plaque PsoriasisPhase 3NCT05975268
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 Phase 3 study testing JS005 (recombinant humanized monoclonal antibody against IL-17A) in people with Moderate to Severe Chronic Plaque Psoriasis, run by Shanghai Junshi Bioscience Co., Ltd. at 63 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Chronic Plaque Psoriasis
- What is being tested?
- JS005 (recombinant humanized monoclonal antibody against IL-17A)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 747 participants
- Where
- 63 sitesChina
- Study dates
- 28 Aug 2023to 3 Sep 2025
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
China63 sites
Baotou Central Hospital
Baotou, Neimenggu, 014040
Inner Mongolia Baotou Steel Hospital
Baotou, Neimengu, 010000
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100044
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100044
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100044
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Peking University Third Hospital
Beijing, Beijing Municipality, 100044
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Beijing, Beijing Municipality, 100864
Beijing LuHe Hospital Capital Medical University
Beijing, Beijing Municipality, 101199
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Bethune First Hospital of Jilin University
Changchun, Jilin, 130021
The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Xiangya Third Hospital, Central South University
Changsha, Hunan, 410013
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Dongguan People's Hospital
Dongguan, Guangdong, 523018
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
The First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi, 341000
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 518107
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310002
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314001
Shandong Dermatology Hospital
Jinan, Shandong, 250000
Jinan Central Hospital
Jinan, Shandong, 250013
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650118
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Lianyungang First People's Hospital
Lianyungang, Jiangsu, 222002
Jiangxi Dermatology Hospital
Nanchang, Jiangxi, 330000
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Nanyang city first People's Hospital
Nanyang, Henan, 473000
Panjin Liao oil precious stone flower hospital
Panjin, Liaoning, 124011
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, 200050
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, 110004
Shenyang Hospital of Integrated Chinese and Western Medicine
Shenyang, Liaoning, 110021
North East Central International Hospital Limited
Shenyang, Liaoning
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Shiyan City People's Hospital
Shiyan, Hubei, 442000
Suining Central Hospital
Suining, Sichuan, 629000
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215123
The Second Hospital of Shanxi Medical University City:Taiyuan
Taiyuan, Shanxi, 030001
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Wuhan University People's Hospital
Wuhan, Hubei, 430060
Wuxi Second People's Hospital
Wuxi, Jiangsu, 214002
The First Affiliated Hospital of Xi 'an Jiaotong University City:Xian
Xi’an, Shanxi, 710061
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, 361023
Medicine School of Xi'an Jiaotong University
Xian, Shanxi, 710004
Xingtai People's Hospital
Xingtai, Hebei, 054031
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, 453100
Yancheng First People's Hospital
Yancheng, Jiangsu, 224006
Ningxia Medical University General Hospital
Yinchuan, Ningxia, 750004
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000
About this study
Official title: 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
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
Read the 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).
- Being tested
- JS005 (recombinant humanized monoclonal antibody against IL-17A)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS005 (recombinant humanized monoclonal antibody against IL-17A)Biological
JS005/placebo
| Study group | Role | What they receive |
|---|---|---|
| JS005 150mg (recombinant humanized monoclonal antibody against IL-17A) | Experimental | Not described Receives: Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A) |
| JS005 300mg (recombinant humanized monoclonal antibody against IL-17A) | Experimental | Not described Receives: Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A) |
| Placebo | Placebo comparator | Not described Receives: Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From week 0 to week 12
Secondary outcomes (9)
Patients achieving PASI 75 at 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
Measured: From week 0 to week 12
Patients achieving PASI 100 at 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
Measured: From week 0 to week 12
Proportion of subjects with a sPGA score of 0 at week 12
The proportion of patients who achieved at least 0 at week 12
Measured: From week 0 to week 12
Proportion of subjects with a DLQI score of 0/1 at week 12
The proportion of patients who with a DLQI score at least 0/1 at week 12
Measured: From week 0 to week 12
Patients achieving PASI 75 at Week 52
Proportion of participants with a PASI score improvement of at least 75% (PASI 75) from baseline at week 52
Measured: From week 0 to week 52
Time to PASI 75/90 response
Time to PASI 75/90 response within 12 weeks
Measured: From week 0 to week 12
Time to sPGA 0/1 response
Time to sPGA 0/1 response within 12 weeks
Measured: From week 0 to week 12
Patients achieving PASI 90 at Week 52
Proportion of participants with a PASI score improvement of at least 90 (PASI 90) from baseline at week 52
Measured: From week 0 to week 52
Patients achieving PASI 100 at Week 52
Proportion of participants with a PASI score improvement of at least 100 from baseline (PASI 100) at week 52
Measured: From week 0 to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start28 Aug 2023
- Primary completion20 Aug 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 747 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975268
- Sponsor's protocol ID
- JS005-005-III-PsO
- Status last verified
- Dec 2025
- First submitted
- 27 Jul 2023
- Last updated
- 16 Dec 2025
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05975268
- Acronym / sponsor ID
- JS005-005-III-PsO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 747 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 3 Aug 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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;
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 |
|---|---|---|
| JS005 (recombinant humanized monoclonal antibody against IL-17A)JS005/placebo | Biological | JS005 150mg (recombinant humanized monoclonal antibody against IL-17A), JS005 300mg (recombinant humanized monoclonal antibody against IL-17A), Placebo |
Primary outcome
Change in PASI 90
Time frame: 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
Time frame: 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.
9 secondary outcomes
Patients achieving PASI 75 at Week 12
Time frame: From week 0 to week 12
Patients achieving PASI 100 at Week 12
Time frame: From week 0 to week 12
Proportion of subjects with a sPGA score of 0 at week 12
Time frame: From week 0 to week 12
Proportion of subjects with a DLQI score of 0/1 at week 12
Time frame: From week 0 to week 12
Patients achieving PASI 75 at Week 52
Time frame: From week 0 to week 52
Time to PASI 75/90 response
Time frame: From week 0 to week 12
Time to sPGA 0/1 response
Time frame: From week 0 to week 12
Patients achieving PASI 90 at Week 52
Time frame: From week 0 to week 52
Patients achieving PASI 100 at Week 52
Time frame: From week 0 to week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Related trials for Moderate to Severe Chronic Plaque Psoriasis
RecruitingPhase 3
Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis
Moderate-to-severe Chronic Plaque Psoriasis
Active, not recruitingPhase 2/3
A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
Moderate-to-severe Chronic Plaque Psoriasis
RecruitingEarly Phase 1
To Check Comparison of Apremilast and Methotrexate Efficacy in Patients With Moderate to Severe Plaque Psoriasis Presented to Tertiary Care Hospital
Chronic Plaque 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.
The record lists no contact. Use the official record to reach the sponsor.
63 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JS005 (recombinant humanized monoclonal antibody against IL-17A) in people with Moderate to Severe Chronic Plaque Psoriasis, run by Shanghai Junshi Bioscience Co., Ltd. at 63 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PASI 90 (time frame: From week 0 to week 12). The study lists 2 primary outcomes in all. 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 16 Dec 2025.