Evaluate the Efficacy, Safety, and Pharmacokinetic Profile and Immunogenicity of Subcutaneous Netakimab in Chinese Adult Patients With Active Ankylosing Spondylitis

NCT ID: NCT07277179

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2025-05-16

Brief Summary

The goal of this clinical trial is to To evaluate the efficacy of subcutaneous (SC) Netakimab in adult Chinese patients with Active Ankylosing Spondylitis. Researchers will compare Netakimab to placebo to see if Netakimab works to treat Ankylosing Spondylitis.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Netakimab

Netakimab administered by subcutaneous injection until Week 52

Group Type: EXPERIMENTAL

Netakimab

Intervention Type: DRUG

Netakimab administered subcutaneously

Placebo

Placebo administered by subcutaneous injection until Week 16 then Netakimab subcutaneous injection until 52 week

Group Type: PLACEBO_COMPARATOR

Netakimab

Intervention Type: DRUG

Netakimab administered subcutaneously

Placebo

Intervention Type: DRUG

Placebo administered subcutaneously

Interventions

Netakimab

Netakimab administered subcutaneously

Intervention Type: DRUG

Placebo

Placebo administered subcutaneously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients fully understand the objectives, procedures and possible adverse reactions of this study, voluntarily participate in the study and sign the informed consent form (ICF) approved by the Institutional Ethics Committee (IEC).

2. Male or female aged 18-65 years (inclusive) on the day of signing the ICF.

3. Patients meet the diagnostic criteria for ankylosing spondylitis (New York criteria as modified in 1984) and have a history of back pain for ≥ 3 months, with onset age < 45 years.

4. BASDAI score ≥ 4 at screening and baseline, and a spinal pain score [using a 0-10-point numerical rating scale (NRS)] of ≥ 4.

5. Suboptimal or no response to NSAIDs.

6. For patients taking NSAIDs regularly as treatment for ankylosing spondylitis, a stable dose of at least 2 weeks is required to be maintained prior to randomization.

7. At screening, if patients have received or are receiving a TNF-α inhibitor (not more than 1), the duration of administration must be no less than 3 months (at an approved dose) and the patients have a poor efficacy or are intolerant of the TNF-α inhibitor.

8. Female patients should have a negative blood pregnancy test.

Exclusion Criteria

1. Complete ankylosis of spine joint with syndesmophyte on the cervical vertebra, thoracic vertebra, and lumbar vertebra sides of all intervertebral spaces.

2. Patients who are known to be allergic to any component of the investigational product or other excipients.

3. Prior use of any monoclonal antibody targeting interleukin 17 (IL-17) or interleukin 17 receptor (IL-17R), IL-12/23, or any other monoclonal antibodies for the treatment of ankylosing spondylitis (except for antibodies targeting TNFα)

4. Current or previous tuberculosis (TB) infection or latent TB

5. History of lymphoproliferative disorders such as lymphoma, or current signs and symptoms suggestive of lymphoproliferative disorders.

6. Any active malignancy or history of malignancy (with the exception of squamous carcinoma in situ or basal cell carcinoma of the skin or cervical cancer in situ with curative outcome) within 5 years prior to screening.

7. Major surgery (including joint surgery) within 3 months prior to screening, or surgery planned during the study.

8. Patients who have the following active infections or history of infections:

9. Presence of hepatitis B [hepatitis B surface antigen positive (HBsAg +), or anti-hepatitis B core antibody positive (HBcAb +) and HBV DNA positive], hepatitis C [hepatitis C antibody (anti-HCV Ab) positive and HCV-RNA positive], human immunodeficiency virus (HIV), or syphilis infection.

10. A history of epileptic seizure or convulsion.

11. Chronic intestinal inflammatory disease (except 'rohn's disease, nonspecific ulcerative colitis).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SPH-BIOCAD (HK) Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

BCD-085-CN02

Identifier Type: -

Identifier Source: org_study_id