Ankylosing SpondylitisPhase 3NCT07277179
Evaluate the Efficacy, Safety, and Pharmacokinetic Profile and Immunogenicity of Subcutaneous Netakimab in Chinese Adult Patients With Active Ankylosing Spondylitis
A Phase 3 study testing Netakimab in people with Ankylosing Spondylitis, run by SPH-BIOCAD (HK) Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Netakimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2023to 16 May 2025
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile and Immunogenicity of Subcutaneous Netakimab in Chinese Adult Patients With Active Ankylosing Spondylitis
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
- Being tested
- Netakimab, Placebo
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NetakimabDrug
Netakimab administered subcutaneously
PlaceboDrug
Placebo administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Netakimab | Experimental | Netakimab administered by subcutaneous injection until Week 52 Receives: Drug: Netakimab |
| Placebo | Placebo comparator | Placebo administered by subcutaneous injection until Week 16 then Netakimab subcutaneous injection until 52 week Receives: Drug: Netakimab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving ASAS40
Proportion of patients achieving 40% improvement criteria established by the International Ankylosing Spondylitis Assessment Task Force at Week 16.
Measured: Week 16
Secondary outcomes (6)
Proportion of patients achieving ASAS20
Proportion of patients achieving 20% improvement criteria established by the International Ankylosing Spondylitis Assessment Task Force at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Measured: at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Proportion of patients achieving ASAS40
Proportion of patients achieving 40% improvement criteria established by the International Ankylosing Spondylitis Assessment Task Force at Week 2, 4, 8, 12, 24, 36, and 52.
Measured: at Week 2, 4, 8, 12, 24, 36, and 52
Proportion of patients achieving ASAS5/6
Proportion of patients achieving ASAS5/6 at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Measured: at Week 2, 4, 8, 12, 16, 24, 36, and 52
Change from baseline in BASDAI
Change from baseline in BASDAI at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Measured: at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Change from baseline in BASMI
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 2, 4, 8, 12, 16, 24, 36, and 52
Measured: at Week 2, 4, 8, 12, 16, 24, 36, and 52
Change from baseline in BASFI
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Measured: at Week 2, 4, 8, 12, 16, 24, 36, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start20 Mar 2023
- Primary completion5 Jul 2024
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPH-BIOCAD (HK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277179
- Sponsor's protocol ID
- BCD-085-CN02
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile and Immunogenicity of Subcutaneous Netakimab in Chinese Adult Patients With Active Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT07277179
- Acronym / sponsor ID
- BCD-085-CN02
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- SPH-BIOCAD (HK) LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Netakimab | Experimental | Drug: NetakimabNetakimab administered by subcutaneous injection until Week 52 |
| Placebo | Placebo comparator | Drug: Netakimab, Drug: PlaceboPlacebo administered by subcutaneous injection until Week 16 then Netakimab subcutaneous injection until 52 week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NetakimabNetakimab administered subcutaneously | Drug | Netakimab, Placebo |
| PlaceboPlacebo administered subcutaneously | Drug | Placebo |
Primary outcome
Proportion of patients achieving ASAS40
Time frame: Week 16
Proportion of patients achieving 40% improvement criteria established by the International Ankylosing Spondylitis Assessment Task Force at Week 16.
6 secondary outcomes
Proportion of patients achieving ASAS20
Time frame: at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Proportion of patients achieving ASAS40
Time frame: at Week 2, 4, 8, 12, 24, 36, and 52
Proportion of patients achieving ASAS5/6
Time frame: at Week 2, 4, 8, 12, 16, 24, 36, and 52
Change from baseline in BASDAI
Time frame: at Week 2, 4, 8, 12, 16, 24, 36, and 52.
Change from baseline in BASMI
Time frame: at Week 2, 4, 8, 12, 16, 24, 36, and 52
Change from baseline in BASFI
Time frame: at Week 2, 4, 8, 12, 16, 24, 36, and 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Netakimab in people with Ankylosing Spondylitis, run by SPH-BIOCAD (HK) Limited at 1 site 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 8 inclusion and 11 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 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of patients achieving ASAS40 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2025.