Please sign in to follow a disease.
Can a new injection shrink nasal polyps and restore easy breathing?
NCT ID NCT07755371
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial is testing an experimental drug called AK139, given as an injection, in people with chronic sinusitis and nasal polyps—growths in the nose that block airflow. The study compares AK139 against a placebo, with all participants also using a standard steroid nasal spray. The goal is to see if AK139 can reduce polyp size and ease nasal congestion better than the spray alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AK139, an experimental biologic given as an injection
- What this could lead to
- If effective, AK139 could offer a new non-surgical option to reduce nasal polyps and improve breathing for people with chronic sinusitis.
- What could go wrong
- This is an early phase II study with a small number of participants, so results may not hold up in larger trials. As a biologic injection, it may also carry side effects like allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 75 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF). 2. Bilateral CRSwNP with prior treatment with systemic corticosteroids (SCS), contraindications to or intolerance of SCS, and/or prior nasal polyp surgery. 3. Nasal Polyp Score (NPS) ≥5, with a minimum score of 2 in each nasal cavity, at screening and baseline. 4. Ongoing nasal congestion/obstruction, with a Nasal Congestion Score (NCS) of 2 or 3 at screening and baseline. 5. Use of intranasal corticosteroids for at least 4 weeks prior to screening. Exclusion Criteria: 1. 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). 2. Presence of any of the following conditions: * Antrochoanal polyp; * Persistent rhinitis medicamentosa; * Allergic fungal rhinosinusitis with symptoms and/or CT findings. 3. Nasal malignant or benign tumors. 4. Severe nasal septal deviation causing obstruction of at least one nostril. 5. Known eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, cystic fibrosis, primary ciliary dyskinesia, or other systemic diseases associated with nasal polyposis. 6. Participants with asthma and FEV1 ≤50% of the predicted value at screening or baseline. 7. Parasitic infection, active tuberculosis, recurrent or chronic infectious diseases, or autoimmune diseases. 8. Acute sinusitis, nasal infection, or upper respiratory tract infection within 2 weeks prior to screening or during the screening period. 9. Chronic infection with hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), or syphilis. 10. Treatment with anti-IL-4Rα monoclonal antibodies, anti-thymic stromal lymphopoietin (TSLP) monoclonal antibodies, anti-immunoglobulin E (IgE) monoclonal antibodies, or other biologic agents within 10 weeks or 5 half-lives (whichever is longer) before randomization, or prior treatment with AK139. 11. Treatment with short- or intermediate-acting systemic corticosteroids within 4 weeks prior to screening, or long-acting systemic corticosteroids within 6 weeks prior to screening. 12. Prior treatment with anti-IL-4Rα monoclonal antibodies with inadequate clinical response.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic rhinosinusitis with nasal polyps (CRSWNP) are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Eye & ENT Hospital of Fudan University
Shanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Brain scans may offer a new way to measure smell recovery
- Can Real-World data improve care for severe nasal polyps?
- Can a common antibiotic keep nasal polyps from coming back?
- Could a Pre-Surgery drug boost nasal polyp treatment?
- New study tests tezepelumab for chronic sinusitis sufferers
- 88% of patients with asthma and nasal polyps achieve dual remission on dupilumab