New injection could help nasal polyp sufferers avoid surgery
NCT ID NCT06516302
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests an experimental drug called GR1802 for adults with severe chronic rhinosinusitis with nasal polyps. The goal is to see if the drug can shrink polyps, ease congestion, and reduce the need for surgery or steroids. 228 participants will receive either GR1802 or a placebo every two weeks for 13 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GR1802 (an experimental drug given as an injection)
- What this could lead to
- If it works, this could provide a new treatment option for people with severe nasal polyps, potentially reducing the need for surgery and steroid use.
- What could go wrong
- This is still an experimental drug in a Phase 3 trial. It may not work better than placebo, and side effects are possible. Results are not yet available.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 228 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2024
- Expected to finish
-
Oct 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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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: * Diagnosed as CRSwNP and treated with systemic glucocorticoid within 2 years before screening; and/or those who had undergone surgery for nasal polyps before screening. * An endoscopic bilateral NPS at screening/lead-in period and the baseline period of at least 5 out of a maximum score of 8 (with a minimum socre of 2 in each nasal cavity). * Nasal congestion/blockade/obstruction with moderate or severe symptom severity at at screening period (score 2 or 3 ) . * Willing to sign an informed consent, able to comply with clinic visits and study-related procedures as per protocol. Exclusion Criteria: * Biologic therapy within 5 half-lives or within 10 weeks before baseline. * Anti-IL-4Rα antibody before screening. * An experimental drug within 5 half-lives or 1 months before baseline. * Systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 2 months or 5 half-lives before baseline. * Initiation of allergen immunotherapy within 3 months before screening. * Participants receiving leukotriene antagonist/modifier before screening unless on continous treatment for at least 30 days. * Participants with FEV1 50% or less of predicted normal were excluded. * Participants who have undergone any intranasal and/or sinus surgery within 6 months before screening. * Acute sinusitis or upper respiratory infection within a defined time period before screening. * A nasal cavity tumor (malignant or benign). * Evidence of fungal rhinosinusitis. * Presence of another diagnosis associated with nasal polyps (i.e., eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, cystic fibrosis). * Rhinitis medicamentosa. * Nasal septal deviation occluding at least one nostril. * Antrochoanal polyps. * Pregnant or lactating woman.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Tongren Hospital, Capital Medical University
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug shrink nasal polyps and restore smell?
- Triple-Action nasal spray could ease chronic sinusitis