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

NCT07277179 | Completed Phase 3

• 1 other identifier: BCD-085-CN02
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving ASAS40

  Proportion of patients achieving 40% improvement criteria established by the International Ankylosing Spondylitis Assessment Task Force at Week 16.

  Week 16

Secondary Outcomes (6)

• Proportion of patients achieving ASAS20

  at Week 2, 4, 8, 12, 16, 24, 36, and 52.

• Proportion of patients achieving ASAS40

  at Week 2, 4, 8, 12, 24, 36, and 52

• Proportion of patients achieving ASAS5/6

  at Week 2, 4, 8, 12, 16, 24, 36, and 52

• Change from baseline in BASDAI

  at Week 2, 4, 8, 12, 16, 24, 36, and 52.

• Change from baseline in BASMI

  at Week 2, 4, 8, 12, 16, 24, 36, and 52

Study Arms (2)

Netakimab

EXPERIMENTAL

Netakimab administered by subcutaneous injection until Week 52

Drug: Netakimab

Placebo

PLACEBO COMPARATOR

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

Drug: Netakimab; Drug: Placebo

Interventions

Netakimab DRUG

Netakimab administered subcutaneously

Netakimab; Placebo

Placebo DRUG

Placebo administered subcutaneously

Placebo

Eligibility Criteria

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

You may qualify if:

• 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).
• Male or female aged 18-65 years (inclusive) on the day of signing the ICF.
• 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.
• BASDAI score ≥ 4 at screening and baseline, and a spinal pain score \[using a 0-10-point numerical rating scale (NRS)\] of ≥ 4.
• Suboptimal or no response to NSAIDs.
• 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.
• 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.
• Female patients should have a negative blood pregnancy test.

You may not qualify if:

• Complete ankylosis of spine joint with syndesmophyte on the cervical vertebra, thoracic vertebra, and lumbar vertebra sides of all intervertebral spaces.
• Patients who are known to be allergic to any component of the investigational product or other excipients.
• 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)
• Current or previous tuberculosis (TB) infection or latent TB
• History of lymphoproliferative disorders such as lymphoma, or current signs and symptoms suggestive of lymphoproliferative disorders.
• 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.
• Major surgery (including joint surgery) within 3 months prior to screening, or surgery planned during the study.
• Patients who have the following active infections or history of infections:
• 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.
• A history of epileptic seizure or convulsion.
• Chronic intestinal inflammatory disease (except 'rohn's disease, nonspecific ulcerative colitis).

Sponsors & Collaborators

• SPH-BIOCAD (HK) Limited: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

netakimab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: March 20, 2023
• Primary Completion: July 5, 2024
• Study Completion: May 16, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)