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

NCT05212051 | Unknown Phase 2

• 1 other identifier: JS005-003-II-AS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 23

Brief 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. 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 .

Conditions

Active Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (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.

  From week 0 to week 16

Secondary Outcomes (11)

• ASAS40 response criteria

  From week 0 to week 16

• ASAS 5/6 response criteria

  From week 0 to week 16

• High-sensitivity C-reactive protein (hsCRP)

  From week 0 to week 16

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  From week 0 to week 16

• Bath Ankylosing Spondylitis Functional Index (BASFI)

  From week 0 to week 16

Other Outcomes (4)

• Pharmacokinetic endpoint

  From baseline to week 24, Total 24 weeks

• Pharmacodynamic endpoint

  From baseline to week 24, Total 24 weeks

• Immunogenicity endpoint

  From baseline to week 24, Total 24 weeks

Study Arms (6)

JS005 150 mg

EXPERIMENTAL

30 patients will be enrolled in this arm.

Biological: JS005

Placebo 150 mg

PLACEBO COMPARATOR

10 patients will be enrolled in this arm.

Biological: Placebo

JS005 300 mg

EXPERIMENTAL

30 patients will be enrolled in this arm.

Biological: JS005

Placebo 300 mg

PLACEBO COMPARATOR

10 patients will be enrolled in this arm.

Biological: Placebo

JS005 450 mg

EXPERIMENTAL

30 patients will be enrolled in this arm.

Biological: JS005

Placebo 450

PLACEBO COMPARATOR

10 patients will be enrolled in this arm.

Biological: Placebo

Interventions

JS005 BIOLOGICAL

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).

Also known as: Recombinant humanized anti-IL-17A monoclonal antibody injection

JS005 150 mg; JS005 300 mg; JS005 450 mg

Placebo BIOLOGICAL

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).

Placebo 150 mg; Placebo 300 mg; Placebo 450

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead
• Sponsor GmbH: collaborator

Study Sites (23)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

NOT YET RECRUITING

Beijing University

Beijing, Beijing Municipality, 100005, China

NOT YET RECRUITING

The First Affiliated Hospital of Xiamen University

Shamen, Fujian, 410011, China

NOT YET RECRUITING

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

Guangzhou, Guangdong, 510120, China

NOT YET RECRUITING

Nanfang Hospital of Nandang Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Shantou University Medical Collge No.1 Affiliated Hospital

Shantou, Guangdong, 515041, China

RECRUITING

Pking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Gudong, 518001, China

NOT YET RECRUITING

Tianjin Medical University General Hospital

Tianjin, Hebei, 300041, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 361001, China

NOT YET RECRUITING

Tongji Hospital Tongji Medical college of HUST

Wuhan, Hubei, 430030, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 361001, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

NOT YET RECRUITING

The Affilated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 100000, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

NOT YET RECRUITING

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116023, China

NOT YET RECRUITING

Shengjing Hospital of China medical University

Shengyang, Liaoning, 110004, China

NOT YET RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

NOT YET RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

NOT YET RECRUITING

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, 650032, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 600041, China

NOT YET RECRUITING

Chuanbei Meidical College Affiliated Hospital

Nanchong, Sichuan, 637000, China

RECRUITING

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

NOT YET RECRUITING

Central Study Contacts

Chengbo Jia, Bachelor

CONTACT

861085172616/8618547265054; chengbo_jia@junshipharma.com

Jiangnian Liu, Bachelor

CONTACT

8618733176288; jiangnian_liu@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Priticipant,Care provider and investigators are masked in this study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 27, 2022
• Study Start: December 10, 2021
• Primary Completion: November 2, 2022
• Study Completion: January 11, 2023
• Last Updated: January 27, 2022

Record last verified: 2021-11

Locations

CN (23)