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A Clinical Study of JS005 in ...

A Clinical Study of JS005 in Patients With Ankylosing Spondylitis

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-12

Study Completion Date

2025-10-08

Brief Summary

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This is a multicentre, randomized, double-blind, parallel, placebo-controlled Phase II clinical study of 261 adults with active ankylosing spondylitis to evaluate the efficacy and safety of JS005 in the treatment of active ankylosing spondylitis.

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Detailed Description

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Conditions

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Ankylosing Spondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo（JS005）

Group Type EXPERIMENTAL

Placebo（JS005）

Intervention Type DRUG

Injection

Recombinant humanized IL-17A Monoclonal Antibody（JS005）150mg

Group Type EXPERIMENTAL

Recombinant humanized IL-17A Monoclonal Antibody（JS005）

Intervention Type DRUG

Injection

Placebo（JS005）

Intervention Type DRUG

Injection

Recombinant humanized IL-17A Monoclonal Antibody（JS005）300mg

Group Type EXPERIMENTAL

Recombinant humanized IL-17A Monoclonal Antibody（JS005）

Intervention Type DRUG

Injection

Placebo（JS005）

Intervention Type DRUG

Injection

Interventions

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Recombinant humanized IL-17A Monoclonal Antibody（JS005）

Injection

Intervention Type DRUG

Placebo（JS005）

Injection

Intervention Type DRUG

Eligibility Criteria

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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. Meet the diagnosis of active Ankylosing Spondylitis(AS), have a record of radiological evidence consistent with the Modified New York Classification Criteria for ankylosing spondylitis as revised in 1984 4. Diagnosis of active AS (active AS is defined as: BASDAI \>= 4, total back pain score \>=4, and BASDAI second question spinal pain score \>=4)

Exclusion Criteria

1. Pregnant or lactating women.
2. Active diseases that may confound the evaluation of JS005: other autoimmune inflammatory diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, vasculitis, etc.) or chronic pain other than ankylosing spondylitis (including but not limited to fibromyalgia, osteoarthritis, etc.).

4\. Active inflammatory bowel disease within 6 months prior to randomization. 5. Recurrent anterior uveitis or acute anterior uveitis within the last 4 weeks prior to randomization.

6\. History or evidence of active or latent tuberculosis (TB), defined as a positive interferon gamma release assay (IGRA) or purified protein derivative (PPD) at the time of screening. 7. Positive hepatitis B virus test result 8. Prior exposure to JS005 or any other biologic that directly targets IL-17 or the IL-17 receptor.

9\. use of \>= 2 TNF-α inhibitors.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huji Xu, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospital

Locations

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