Phase IIIPhase 3NCT07498634

Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection in the Treatment of Moderate-to-Severe Active AS

A Phase 3 study testing XKH004 in people with Phase III, run by Zhejiang Kanova Biopharmaceutical Co., LTD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled, and parallel grouping study. Study procedures: The screening period does not exceed 4 weeks, including 16 weeks for initial treatment, 28 weeks for maintenance treatment and 8 weeks for safety follow-up. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Phase III
What is being tested?: XKH004
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 323 participants
Where: 1 siteChina
Study dates: 21 Sep 2023to 14 Nov 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female age ≥ 18;
Ability to understand and communicate with the Investigator, ability to comply with study requirements, and ability to sign the ICF prior to any study assessments;
Patients with active AS, who are eligible for the revised New York Criteria (1984) based on radiological evidence (i.e., x-ray) of readings by the study site and have a persistent symptom of chronic back pain for ≥3 months at the age of <45 years for the first onset of symptoms;
Patients who meet the criteria for moderate to severe activity defined as follows at screening and baseline visits: 1) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4; 2) Spinal pain ≥ 4 as measured by Question 2 of BASDAI; 3) Total back pain ≥ 4 as measured by Question 1 of Back Pain Intensity Assessment (NRS score);
Must have at least one of the following: Inadequate response, or intolerance, or contraindications to NSAIDs. Incomplete response to NSAIDs treatment, defined as no response after ≥ 4 weeks of continuous use of one NSAIDs of approved doses, or noresponse after use of more than 2 NSAIDs of approved doses for a cumulative duration of ≥ 4 weeks (≥ 2 weeks of use of either NSAIDs);
Patients who take NSAIDs or analgesics (including opioids with mild potency) or glucocorticoids orally shall maintain a stable dose for at least 2 weeks before randomization (oral dose of glucocorticoids shall be ≤ 10 mg/d of prednisone or equivalent);

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Patients who have started taking methotrexate [≤ 25 mg/week] or sulfasalazine [≤ 3 g/day] or hydroxychloroquine [≤ 400 mg/day] at least 12 weeks before randomization, and whose dose and route of administration have been stable for at least 4 weeks before randomization can continue this drug (folic acid supplementation is recommended for patients taking MTX); if it is not in stable use, a washout period of at least 4 weeks is required;
TNFi-experienced patients must have had incomplete response to at least 12 weeks of treatment with the approved dose, or be intolerant to treatment;
Patients who agree to take effective contraception during the study and within 6 months after the last dose.

Who cannot join

Pregnant or lactating women, or women who plan to become pregnant during the study or within 6 months after the last dose;
Have participated in a clinical study of XKH004 and received at least 1 dose (including placebo);
Allergy to the ingredients or excipients of XKH004，allergy to biologics or allergic constitution;
Have participated in another drug clinical study within 3 months or at least 5 half-lives (whichever is longer) before screening, or participated in any medical device clinical study within 1 month before screening;
Complete rigidity of the spine or complete fusion of the bilateral sacroiliac joints;
Symptoms of fibromyalgia or osteoarthritis that may interfere with the efficacy evaluation as considered by the Investigator;

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Acute uveitis anterior within 6 weeks before randomization;
Patients who have received more than 1 TNFi, or more than 2 non-TNF-α targeted biological immunomodulators, or any biological immunomodulators targeting IL-17 or IL-17R;
Patients who are taking or have taken prohibited drugs listed in Table 2, with the mandatory washout period not reached relative to randomization (baseline visit) (5 half-lives of washout for unlisted biologics/drugs);
Have received live vaccines (including attenuated vaccines) 2 months before randomization or are planned to receive live vaccines (including attenuated vaccines) during the study. Subjects who had received COVID-19 vaccine within 1 week prior to randomization;
Subjects with tuberculosis (TB) infection, or at high risk for acquired TB infection, or with present nontuberculous mycobacteria (NTMB) infection or previous NTMB infection;
Patients with latent tuberculosis (LTB) [IGRA positive and diagnosed as LTB by a TB specialist] who did not develop hepatotoxicity (alanine aminotransferase [ALT]/aspartate aminotransferase [AST] maintained ≤3 × ULN) before the first dose of the investigational drug after at least 4 weeks of appropriate anti-TB treatment may be rescreened once. Positive IGRA at the second screening is not an exclusion criterion.
Patients with a prior history of active TB involving any organ system were excluded, except in cases where they were deemed as fully recovered by local treatment guidelines after adequate treatment.
Patients with the following active infections or a history of infections:
1) Active infection (except for common cold) within 14 days before randomization; 2) Severe infection requiring hospitalization or intravenous infusion of anti-infective drugs within 2 months before randomization; 3) Previous opportunistic infections and recurrent or chronic infectious diseases. Opportunistic infections are infections caused by uncommon pathogens (e.g., Pneumocystis carinii, Cryptococcus and Candida) or unusually severe infections caused by common pathogens (e.g., Cytomegalovirus and Herpes Zoster Virus); 13. Acute or chronic viral hepatitis B or C, or HIV infection;
Subjects with evidence or positive results for hepatitis B or C were excluded from the study. A positive hepatitis B (HBV) test is defined as a positive hepatitis B surface antigen (HBsAg+); or a positive anti-hepatitis B core antibody (HBcAb+) and an HBV-DNA test >ULN.
A positive hepatitis C (HCV) test is defined as a positive hepatitis C antibody (HCV-Ab) and a positive HCV-RNA by quantitative determination.
14. Subjects with a history of lymphoproliferative diseases such as lymphoma or current signs and symptoms suggestive of lymphoproliferative diseases; 15. Subjects with any active malignant tumors or history of malignancy within 5 years before the screening visit, except for treated and considered cured skin squamous or basal cell carcinoma or cervical cancer in situ; 16. Inflammatory diseases other than AS (including but not limited to Rh arthritis, sarcoidosis (nodule disease), systemic lupus erythematosus or arthritis reactive). Patients diagnosed with Crohn's disease or colitis ulcerative or other IBD may also be included in this study if they have no active symptoms at screening or baseline; 17. Myocardial infarction or stroke within 6 months before screening; 18. Major surgery (including joint surgery) within 3 months before randomization, or surgery planned within 6 months after entering the study; 19. Patients with any uncontrolled, unstable or clinically significant progressive systemic diseases (i.e. cardiovascular, neurological, renal, hepatic, metabolic, gastrointestinal, hematological, immune, etc.) as judged by the Investigator during the study; 20. Subjects with the following laboratory abnormalities at screening, including: 1) ALT, AST or ALP ≥3.0 x ULN; or total bilirubin (TBIL) > ULN (TBIL ≥ 1.5 x ULN if known to have Gilbert's syndrome); 2) White blood cell (WBC) count <3000/μL; 3) Absolute neutrophil count <1500/μL; 4) Absolute lymphocyte count < 500/μL; 5) Hemoglobin (HGB) < 8.5 g/dL or 85 g/L; 6) Blood creatinine > 2 mg/dL (176.8 μmol/L); 7) Any other laboratory abnormalities that may preclude the patient from completing the study or interfere with the interpretation of the study results as judged by the Investigator;
If the result of a single laboratory test at screening is suspected to be an error value, or a boundary value, or the value does not allow for the determination of a subject's eligibility for inclusion in the study, the test may be repeated once (only once) during screening to confirm the diagnosis. If the retest result still exceeds the threshold, the patient fails screening.
21. Moderate to severe depressive disorder, i.e. Patient Health Questionnaire-9 (PHQ-9) score ≥ 15. The dosing of antidepressant drugs shall remain stable within 8 weeks before randomization; 22. History of attempted suicide, or suicidal ideation within 1 month prior to the screening visit, i.e., affirmative response ('Yes') to Question 4 or 5 of the C-SSRS (Columbia-Suicide Severity Rating Scale); 23. Patients with other physical or mental conditions that are not suitable for the study as judged by the Investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Changzheng Hospital
Shanghai

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection in the Treatment of Moderate-to-Severe Active Ankylosing Spondylitis (AS)

This is a multicenter, randomized, double-blind, placebo-controlled, and parallel grouping study.

Study procedures: The screening period does not exceed 4 weeks, including 16 weeks for initial treatment, 28 weeks for maintenance treatment and 8 weeks for safety follow-up.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, and parallel grouping study.

Study procedures: The screening period does not exceed 4 weeks, including 16 weeks for initial treatment, 28 weeks for maintenance treatment and 8 weeks for safety follow-up.

Eligible patients are randomized at a ratio of 1:1 (stratification factors include: TNFi-incomplete response vs. TNFi-naive; weight ≥ 70 kg vs. weight < 70 kg) to the following 2 groups (Group 1 and Group 2).

During the initial treatment period, patients in Group 1 shall be treated with XKH004(160 mg, Q4W) by subcutaneous injection while those in Group 2 shall receive a placebo.

During the maintenance treatment period, starting at Week 16 (W16), patients in Group 1 shall maintain the original treatment (continue 160 mg, Q4W) and patients in Group 2 shall switch from placebo to XKH004 (160 mg, Q4W).

Patients who have received TNFi therapy in the initial treatment period will account for approximately 20% of the total sample size to make this population representative.

All patients will undergo the efficacy/safety/immunogenicity assessment procedures specified in the protocol at visit points such as W1, W2, W4 and every 4 weeks thereafter until W44 and W52.

Conditions: Phase III
Being tested: XKH004, Placebo
Keywords: Active Ankylosing Spondylitis (AS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XKH004Drug
Also called Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection
Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection
PlaceboDrug
Placebo

Study groups in NCT07498634
Study group	Role	What they receive
XKH004	Active comparator	XKH004 160 mg sc Q4W (W0, W4, W8, W12)；XKH004 160 mg sc Q4W (W16, W20, W24, W28 W32, W36, W40) Receives: Drug: XKH004
Placebo	Placebo comparator	Placebo sc Q4W(W0,W4,W8,W12)；XKH004 160 mg sc Q4W (W16, W20, W24, W28 W32, W36, W40) Receives: Drug: XKH004; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Is ASAS 40 achieved at W16?
To evaluate the efficacy of XKH004 in the treatment of moderate to severe active AS based on the proportion of patients achieving ASAS 40 at 16 weeks of treatment.
Measured: Week 16

Secondary outcomes (1)

Is ASAS 20 achieved at W16?
To evaluate the efficacy of XKH004 in the treatment of moderate to severe active AS based on the proportion of patients achieving ASAS 20 at 16 weeks of treatment.
Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 202314 Nov 2025

First posted27 Mar 2026
Study start21 Sep 2023
Primary completion1 Aug 2025
Study completion14 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Phase IIIStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07498634
Sponsor's protocol ID: XKH004-01-III
Status last verified: Mar 2026
First submitted: 18 Mar 2026
Last updated: 27 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Phase III trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection in the Treatment of Moderate-to-Severe Active Ankylosing Spondylitis (AS)
ClinicalTrials.gov ID: NCT07498634
Acronym / sponsor ID: XKH004-01-III
Conditions: Phase III
Keywords: Active Ankylosing Spondylitis (AS)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: Zhejiang Kanova Biopharmaceutical Co., LTDIndustry (pharma, biotech, devices)
Study start: 21 Sep 2023 (actual)
Primary completion: 1 Aug 2025 (actual)
Study completion: 14 Nov 2025 (actual)
First posted: 27 Mar 2026 (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.

This is a multicenter, randomized, double-blind, placebo-controlled, and parallel grouping study.

Study procedures: The screening period does not exceed 4 weeks, including 16 weeks for initial treatment, 28 weeks for maintenance treatment and 8 weeks for safety follow-up.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, and parallel grouping study.

Study procedures: The screening period does not exceed 4 weeks, including 16 weeks for initial treatment, 28 weeks for maintenance treatment and 8 weeks for safety follow-up.

During the initial treatment period, patients in Group 1 shall be treated with XKH004(160 mg, Q4W) by subcutaneous injection while those in Group 2 shall receive a placebo.

Patients who have received TNFi therapy in the initial treatment period will account for approximately 20% of the total sample size to make this population representative.

All patients will undergo the efficacy/safety/immunogenicity assessment procedures specified in the protocol at visit points such as W1, W2, W4 and every 4 weeks thereafter until W44 and W52.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
XKH004	Active comparator	Drug: XKH004XKH004 160 mg sc Q4W (W0, W4, W8, W12)；XKH004 160 mg sc Q4W (W16, W20, W24, W28 W32, W36, W40)
Placebo	Placebo comparator	Drug: XKH004, Drug: PlaceboPlacebo sc Q4W(W0,W4,W8,W12)；XKH004 160 mg sc Q4W (W16, W20, W24, W28 W32, W36, W40)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female age ≥ 18;
Ability to understand and communicate with the Investigator, ability to comply with study requirements, and ability to sign the ICF prior to any study assessments;
Patients with active AS, who are eligible for the revised New York Criteria (1984) based on radiological evidence (i.e., x-ray) of readings by the study site and have a persistent symptom of chronic back pain for ≥3 months at the age of <45 years for the first onset of symptoms;
Patients who meet the criteria for moderate to severe activity defined as follows at screening and baseline visits: 1) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4; 2) Spinal pain ≥ 4 as measured by Question 2 of BASDAI; 3) Total back pain ≥ 4 as measured by Question 1 of Back Pain Intensity Assessment (NRS score);
Must have at least one of the following: Inadequate response, or intolerance, or contraindications to NSAIDs. Incomplete response to NSAIDs treatment, defined as no response after ≥ 4 weeks of continuous use of one NSAIDs of approved doses, or noresponse after use of more than 2 NSAIDs of approved doses for a cumulative duration of ≥ 4 weeks (≥ 2 weeks of use of either NSAIDs);

Key exclusion criteria (20 listed)

Pregnant or lactating women, or women who plan to become pregnant during the study or within 6 months after the last dose;
Have participated in a clinical study of XKH004 and received at least 1 dose (including placebo);
Allergy to the ingredients or excipients of XKH004，allergy to biologics or allergic constitution;
Have participated in another drug clinical study within 3 months or at least 5 half-lives (whichever is longer) before screening, or participated in any medical device clinical study within 1 month before screening;
Complete rigidity of the spine or complete fusion of the bilateral sacroiliac joints;

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
XKH004Also: Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody InjectionRecombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection	Drug	Placebo, XKH004
PlaceboPlacebo	Drug	Placebo

Primary outcome

Is ASAS 40 achieved at W16?
Time frame: Week 16
To evaluate the efficacy of XKH004 in the treatment of moderate to severe active AS based on the proportion of patients achieving ASAS 40 at 16 weeks of treatment.

1 secondary outcome

Is ASAS 20 achieved at W16?
Time frame: Week 16

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 27 Mar 2026.

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Active, not recruitingPhase 3
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A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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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.

Huji Xu, PHD principal investigator

Shanghai Changzheng Hospital

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 XKH004 in people with Phase III, run by Zhejiang Kanova Biopharmaceutical Co., LTD 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 9 inclusion and 20 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 27 Mar 2026. 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?

Is ASAS 40 achieved at W16? (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07498634.

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 27 Mar 2026.