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Active Ankylosing SpondylitisPhase 2NCT05212051

Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active AS

A Phase 2 study testing JS005 in people with Active Ankylosing Spondylitis, run by Shanghai Junshi Bioscience Co., Ltd. at 23 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate preliminary efficacy, safety pharmacokinetic (PK) characteristics, pharmacodynamics (PD) haracteristics and immunogenicity of JS005 at different doses in Chinese patients with active Ankylosing Spondylitis. Treatment difference of JS005 150mg,300mg,450mg vs. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Active Ankylosing Spondylitis
What is being tested?
JS005
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
131 participants
Where
23 sitesChina
Study dates
1 Apr 2021to 22 Mar 2023
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have an established diagnosis of AS according to Modified New York criteria for AS in 1984, and active AS assessed by total BASDAI ≥ 4 (0-10 point scale) and spinal pain ≥ 4 （according to the 0-10 NRS scale ( BASDAI question #2) at baseline.
  • Voluntarily participate in this clinical trial and sign the informed consent form.
  • Male or female aged between 18 and 65 years (both inclusive) at the time of signing informed consent. Female subjects of childbearing age are required to have a confirmed negative result of urine and/or serum pregnancy test performed within 3 days before randomization and agree to use reliable contraceptive measures during the study; Male patients and their female partners of childbearing age must agree to use reliable contraception during the study.
  • Patients meet at least one of the following: 1) have an inadequate or ineffective response to NSAIDs, 2) have been intolerant to at least one dose of NSAIDs, 3) have contraindications to NSAIDs therapy. Inadequate or ineffective response to NSAIDs is defined as no remission after continuous treatment with standard doses of at least 2 NSAIDs for a total of no less than 4 weeks and no less than 2 weeks for each NSAID.
  • Patients regularly taking NSAIDs as part of their AS therapy are required to maintain a stable dose for at least 2 weeks prior to randomization.
  • Patients using tumor necrosis factor α (TNFα) inhibitors must have experienced an inadequate response to the standard treatment doses for at least 3 months, or have been intolerant to anti-TNFα agents.
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  • Patients who have previously been on a TNFα inhibitor will be allowed entry into study after an appropriate wash-out period prior to randomization (e.g., washout periods of 4 weeks for etanercept, 8 weeks for infliximab, and 10 weeks for adalimumab, golimumab, and certolizumab, respectively).
  • Patients taking Methotrexate (MTX) (≤ 25 mg/week) or sulfasalazine (SSZ) ( ≤ 3 g/day) are allowed to continue their medication and must have taken it for at least 3 months and be on a stable dose for at least 4 weeks prior to randomization. Patients taking MTX need to take folic acid supplements.
  • Patients who are on conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) other than MTX and sulfasalazine must discontinue the csDMARDs 4 weeks prior to randomization, except for leflunomide (LEF), which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine washout has been performed.
  • Patients taking systemic corticosteroids have to be on a stable dose of ≤ 10 mg/day prednisone or equivalent for at least 2 weeks prior to randomization

Who cannot join

  • Patients with total ankylosis of the spine or imaging (X-ray) with the evidence of sacroiliitis with complete fusion of sacroiliac joints.
  • Previous exposure to JS005 or any other biologic drug directly targeting IL-17 or IL-17 receptors.
  • Have taken high potency analgesics (e.g., opiates of methadone, hydromorphone, morphine) within 2 weeks prior to randomization.
  • Previous treatment with any intra-articular injection (e.g., glucocorticoids) within 4 weeks prior to randomization.
  • Previous treatment with any biological immunomodulating agents other than the TNFα inhibitors.
  • Treatment with JAK inhibitor agents within 8 weeks prior to randomization and unwilling to discontinue during the study.
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  • Patient unwilling to take folic acid/leucovorin to reduce MTX toxicity.
  • Has received any cell-depletion therapies including but not limited to anti-CD20 antibodies, or investigational agents (e.g., Campath, anti-CD4 , anti-CD5, anti-CD3, anti-CD19).
  • Previous treatment with traditional Chinese medicine or animal and plant extracts for AS within 4 weeks prior to randomization.
  • Use of any investigational agents and/or devices within 4 weeks prior to randomization or within 5 half-lives of the investigational drug, whichever is longer.
  • Females who are pregnant or lactating.
  • Chest imaging (e.g., x-ray or CT) with evidence of ongoing infectious or malignancy, obtained within 3 months prior to screening and evaluated by a qualified physician
  • Active systemic infections (other than the common cold) within 2 weeks prior to randomization.
  • Patients with other diseases other than ankylosing spondylitis that might confound the evaluation of the efficacy of JS005 therapy: such as chronic pain other than ankylosing spondylitis (such as fibromyalgia), inflammatory bowel disease, acute anterior uveitis, etc., within 6 weeks prior to randomization. However, patients with non-acute iritis and psoriasis that have been stable for 6 months or more can be included in this study.
  • Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious, or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk in case of using immunomodulatory therapy.
  • Myocardial infarction, apoplexy, congestive heart failure (New York Heart Association status of class III or IV) within 6 months prior to screening; uncontrolled hypertension (≥ 160/95 mmHg) prior to randomization.
  • Patients with type 1 diabetes mellitus, or newly diagnosed or uncontrolled type 2 diabetes mellitus (e.g., HbA1C > 9.0%) within 6 months prior to screening.
  • Patients with active liver disease or hepatic insufficiency, with any of the following abnormalities in liver function tests at screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin > 1.5 × upper limit of normal.
  • History of renal injury, glomerulonephritis, or patient with only one kidney or glomerular filtration rate < 60 mL/(min · 1.73 m2 ) at screening.
  • Total white blood cell count < 3 × 109/L, or neutrophils < 1.5 × 109/L or absolute lymphocyte count < 0.5 × 109/L or hemoglobin < 8.5 g/dL or platelets < 100 × 109/L at screening.
  • History of ongoing chronic or recurrent infectious disease, or evidence of tuberculosis infection on tuberculosis screening (X. DOT-TB, QuantiFERON TB-Gold, T-SPOT) (see Section 8.3.4 for details).
  • Positive for human immunodeficiency virus antibody (Anti-HIV) at screening.
  • Positive for hepatitis C virus antibody (Anti-HCV) at screening.
  • HBV DNA is detected in patients with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening (the lower limit of quantitative detection refers to the reference value of each hospital.).
  • History of lymphoproliferative disease or malignancy within the past 5 years (except for basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 3 months, and carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been surgically removed ).
  • Previous or medical history of other significant concomitant diseases that, in the judgment of the investigator, participation would not be in the best interest of the patient. These include, but are not limited to, cardiovascular disorder, nephropathy, neurological disease (including demyelinating disease), active infectious disease, endocrine disease, gastrointestinal disease, hepatobiliary disease, metabolic disease, pulmonary disease, non-malignant lymphoproliferative disease, or other lymphatic diseases.
  • Surgery of the spine or joint or other major surgery (e.g., aneurysmectomy, gastric ligation) within 3 months prior to randomization or planned during the study.
  • History or evidence of ongoing alcohol or drug abuse within 6 months prior to randomization.
  • The patient has a history of systemic hypersensitivity to any biological agent, excluding injection site reactions.
  • Vaccination with a live vaccine (live attenuated vaccine*) and BCG vaccine within 12 weeks prior to randomization

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

China23 sites

  • Beijing University

    Beijing, Beijing Municipality, 100005

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 361001

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 600041

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

  • Sun Yat-sen Memorial Sun Yat-sen University City: Guangzhou

    Guangzhou, Guangdong, 510120

  • Nanfang Hospital of Nandang Medical University

    Guangzhou, Guangdong, 510515

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • The Affilated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 100000

  • Chuanbei Meidical College Affiliated Hospital

    Nanchong, Sichuan, 637000

  • The First Affiliated Hospital of Xiamen University

    Shamen, Fujian, 410011

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • Shantou University Medical Collge No.1 Affiliated Hospital

    Shantou, Guangdong, 515041

  • Shengjing Hospital of China medical University

    Shengyang, Liaoning, 110004

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Pking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • Shenzhen People's Hospital

    Shenzhen, Gudong, 518001

  • The First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 650032

  • Tianjin Medical University General Hospital

    Tianjin, Hebei, 300041

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830001

  • Tongji Hospital Tongji Medical college of HUST

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 361001

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase II, Multicenter Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacokinetics of Subcutaneous JS005 in Chinese Adult Patients With Active Ankylosing Spondylitis

The purpose of this study is to evaluate preliminary efficacy, safety pharmacokinetic (PK) characteristics, pharmacodynamics (PD) haracteristics and immunogenicity of JS005 at different doses in Chinese patients with active Ankylosing Spondylitis. Treatment difference of JS005 150mg,300mg,450mg vs. placebo in Chinese AS patients in terms of ASAS 20 response rate at Week 16 as well as safety profile will be provided by the study .

Read the detailed description

This is a randomized, double-blind, placebo-controlled study. Approximately 120 patients who meet the eligibility criteria will be randomized to one of three treatment cohorts (JS005 150 mg, 300 mg, 450mg in a ratio of 1:1:1),then using secondary randomization method, 40 patients in each group will be randomized in a 3: 1 ratio to receive investigational product or placebo.

  1. JS005 150mg Cohort: JS005 150 mg or placebo treatment(JS005:Placrbo=3:1) s.c. prefilled syringe (PFS) on Week 0, 1, 2, 3, 4,8 and 12
  2. JS005 300mg Cohort: JS005 300 mg or placebo treatment(JS005:Placrbo=3:1) s.c. PFS on Week0, 1, 2 ,3, 4,8,and 12 3 .JS005 450mg Cohort: JS005 450 mg or placebo treatment(JS005:Placrbo=3:1) s.c. PFS on Week0, 1, 2 ,3, 4,8,and 12 Based on the clinical judgment of disease activity by the investigator and the patient, background medications, such as NSAIDs and DMARDs, may have been modified or added to treat signs and symptoms of AS from Week 16 on.
Being tested
JS005, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS005Biological

    Also called Recombinant humanized anti-IL-17A monoclonal antibody injection

    30 subjectes in JS005 150mg chort, JS005 300mg chort, and JS005 450mg chort receive JS005 150mg, JS005 300mg and JS005 450mg subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).

  • PlaceboBiological

    10 subjects in JS005 150mg chort, JS005 300mg chort, and JS005 450mgchort receive the placebo subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).

Study groups in NCT05212051
Study groupRoleWhat they receive
JS005 150 mgExperimental30 patients will be enrolled in this arm.
Receives: Biological: JS005
Placebo 150 mgPlacebo comparator10 patients will be enrolled in this arm.
Receives: Biological: Placebo
JS005 300 mgExperimental30 patients will be enrolled in this arm.
Receives: Biological: JS005
Placebo 300 mgPlacebo comparator10 patients will be enrolled in this arm.
Receives: Biological: Placebo
JS005 450 mgExperimental30 patients will be enrolled in this arm.
Receives: Biological: JS005
Placebo 450Placebo comparator10 patients will be enrolled in this arm.
Receives: Biological: Placebo

What is being measured

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

  1. Primary efficacy endpoint

    The proportion of AS patients meeting the Assessment of Spondylo Arthritis international Society 20 (ASAS20) response criteria at the end of treatment Week 16.

    Measured: From week 0 to week 16

Secondary outcomes (11)

  1. ASAS40 response criteria

    The proportion of patients meeting the ASAS40 response criteria at the end of treatment Week 16;

    Measured: From week 0 to week 16

  2. ASAS 5/6 response criteria

    The proportion of patients meeting the ASAS 5/6 response criteria at the end of treatment Week 16;

    Measured: From week 0 to week 16

  3. High-sensitivity C-reactive protein (hsCRP)

    The change from baseline in high-sensitivity C-reactive protein (hsCRP) at the end of treatment Week 16

    Measured: From week 0 to week 16

  4. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    The change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the end of treatment Week 16;

    Measured: From week 0 to week 16

  5. Bath Ankylosing Spondylitis Functional Index (BASFI)

    The change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at the end of treatment Week 16

    Measured: From week 0 to week 16

  6. Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)

    The change from baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at the end of treatment Week 16

    Measured: From week 0 to week 16

  7. Bath Ankylosing Spondylitis Disease Metrology Index (BASMI)

    The change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at the end of treatment Week 16

    Measured: From week 0 to week 16

  8. The proportion of patients meeting the ASAS partial remission criteria

    The proportion of patients meeting the ASAS partial remission criteria at the end of treatment Week 16

    Measured: From week 0 to week 16

  9. nkylosing Spondylitis Disease Activity Score (ASDAS-CRP)

    The change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at the end of treatment Week 16;

    Measured: From week 0 to week 16

  10. The patient's global assessment of disease activity

    The change from baseline in the patient's global assessment of disease activity at the end of treatment Week 16

    Measured: From week 0 to week 16

  11. The patient's assessment of inflammatory back pain intensity

    The change from baseline in the patient's assessment of inflammatory back pain intensity at the end of treatment Week 16

    Measured: From week 0 to week 16

Timeline

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

  1. First posted27 Jan 2022
  2. Study start1 Apr 2021
  3. Primary completion28 Dec 2022
  4. Study completion22 Mar 2023

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05212051
Sponsor's protocol ID
JS005-003-II-AS
Status last verified
Jul 2026
First submitted
30 Nov 2021
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JS005 in people with Active Ankylosing Spondylitis, run by Shanghai Junshi Bioscience Co., Ltd. at 23 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 10 inclusion and 30 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Primary efficacy endpoint (time frame: From week 0 to week 16). 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 NCT05212051.

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 21 Jul 2026.

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