A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Rhinosinusitis … (NCT07755371) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Rhinosinusitis With Nasal Polyps
China75 participantsStarted 2026-08-10
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 injection compared with placebo in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) receiving background treatment with mometasone furoate nasal spray (MFNS).
Who can participate
Age range
18 Years – 75 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 participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF).
. Bilateral CRSwNP with prior treatment with systemic corticosteroids (SCS), contraindications to or intolerance of SCS, and/or prior nasal polyp surgery.
. Nasal Polyp Score (NPS) ≥5, with a minimum score of 2 in each nasal cavity, at screening and baseline.
. Ongoing nasal congestion/obstruction, with a Nasal Congestion Score (NCS) of 2 or 3 at screening and baseline.
. Use of intranasal corticosteroids for at least 4 weeks prior to screening.
Exclusion criteria
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.
. History of sinonasal surgery (including nasal polypectomy) within 6 months prior to screening, or prior nasal surgery resulting in structural changes that preclude adequate assessment of Nasal Polyp Score (NPS).
. Presence of any of the following conditions:
. Nasal malignant or benign tumors.
. Severe nasal septal deviation causing obstruction of at least one nostril.
. Known eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, cystic fibrosis, primary ciliary dyskinesia, or other systemic diseases associated with nasal polyposis.
. Participants with asthma and FEV1 ≤50% of the predicted value at screening or baseline.
. Parasitic infection, active tuberculosis, recurrent or chronic infectious diseases, or autoimmune diseases.
. Acute sinusitis, nasal infection, or upper respiratory tract infection within 2 weeks prior to screening or during the screening period.