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

NCT07498634 | Completed Phase 3 DMC

• 1 other identifier: XKH004-01-III
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Phase III

Keywords

Active Ankylosing Spondylitis (AS)

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 16

Secondary Outcomes (1)

• Is ASAS 20 achieved at W16?

  Week 16

Study Arms (2)

XKH004

ACTIVE COMPARATOR

XKH004 160 mg sc Q4W (W0, W4, W8, W12)；XKH004 160 mg sc Q4W (W16, W20, W24, W28 W32, W36, W40)

Drug: XKH004

Placebo

PLACEBO COMPARATOR

Placebo sc Q4W(W0,W4,W8,W12)；XKH004 160 mg sc Q4W (W16, W20, W24, W28 W32, W36, W40)

Drug: XKH004; Drug: Placebo

Interventions

XKH004 DRUG

Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection

Also known as: Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection

Placebo; XKH004

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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;
• 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 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:
• \) 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.

Sponsors & Collaborators

• Zhejiang Kanova Biopharmaceutical Co., LTD: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, China

Location

Study Officials

• Huji Xu, PHD

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: September 21, 2023
• Primary Completion: August 1, 2025
• Study Completion: November 14, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)