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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;