Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection in the Treatment of Moder… (NCT07498634) | Clinical Trial Compass
CompletedPhase 3
Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection in the Treatment of Moderate-to-Severe Active AS
China323 participantsStarted 2023-09-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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;