Chronic Rhinosinusitis With Nasal PolypsPhase 3NCT06516302
A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps
A Phase 3 study testing GR1802 in people with Chronic Rhinosinusitis With Nasal Polyps, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if GR1802 works to treat severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. It will also learn about the safety of GR1802. The main questions it aims to answer are: 1. Does GR1802 reduce the need for surgery and systemic corticosteroid use？ 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- GR1802
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2024to 13 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy, Safety, and Immunogenicity of GR1802 in Participants With Chronic Rhinosinusitis With Nasal Polyps
The goal of this clinical trial is to learn if GR1802 works to treat severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. It will also learn about the safety of GR1802. The main questions it aims to answer are:
- Does GR1802 reduce the need for surgery and systemic corticosteroid use？
- What medical problems do participants have when taking GR1802?
Read more
Researchers will compare GR1802 to a placebo (a look-alike substance that contains no drug) to see if GR1802 works to treat CRSwNP.
Participants will:
Take GR1802 or a placebo once every 2 weeks for 13months. Visit the clinic once every 2 weeks for checkups and tests. Keep a diary of their symptoms and the dosage and number of times they use mometasone furoate nasal spray.
Read the detailed description
A randomized, double-blind, placebo-controlled, multi-center clinical trial was designed. The clinical trial was divided into 4 stages: screening/introduction period, double-blind treatment period , maintenance treatment period and safety follow-up period.
The clinical trial aimed to evaluate the efficacy, safety and immunogenicity of GR1802 injection in CRSwNP participants.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- GR1802, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR1802Drug
GR1802 will be administered SC.
PlaceboDrug
The placebo will be administered SC.
| Study group | Role | What they receive |
|---|---|---|
| GR1802 group | Experimental | GR1802 300mg is administrated every 2 weeks (first dose doubled) for a total of 26 doses, of which an additional 2 ml of placebo is given at week 24. Receives: Drug: GR1802 |
| placebo group | Placebo comparator | Placebo is administered every 2 weeks for the first 16 weeks. GR1802 is given every 2 weeks from week 24 to W50. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in nasal polyps score at week 24.
Nasal polyps score score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Measured: At week 24
Change from baseline in nasal congestion score at week 24.
Nasal congestion score (0-3), higher score means worse nasal symptom.
Measured: At week 24
Secondary outcomes (20)
Change from baseline in reduction/loss of smell at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and 60.
The reduction/loss of smell severity was reported by the participant on a daily basis using a 0 to 3 categorical scale. Higher score means a worse sense of smell.
Measured: From baseline to week 60
Change from baseline in nasal discharge (anterior/posterior) at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and 60.
The nasal discharge severity was reported by the participant on a daily basis using a 0 to 3 categorical scale. Higher score means a worse nasal symptom.
Measured: From baseline to week 60
Change from baseline in Total Nasal Symptom Score (TNSS) at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and 60.
TNSS score (0-9). Higher score means worse nasal symptom.
Measured: From baseline to week 60
Change from baseline in nasal endoscopy nasal polyps score in participants with a high power field of vision < 55 eosinophil granulocytes in nasal polyp tissue at week 24.
Nasal polyps score score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Measured: At week 24
Change from baseline in nasal congestion score in participants with a high power field of vision < 55 eosinophil granulocytes in nasal polyp tissue at week 24.
Nasal congestion score (0-3), higher score means worse nasal symptom.
Measured: At week 24
Change from baseline in nasal polyps score at weeks 2、4、8、16、32、40、52 and 60.
Nasal polyps score score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Measured: From baseline to week 60
Proportion of participants with improvement by at least 1 point in nasal polyps score at weeks 2、4、8、16、24、32、40、52 and 60.
Nasal polyps score score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Measured: From baseline to week 60
Proportion of participants with improvement by at least 2 point in nasal polyps score at weeks 2、4、8、16、24、32、40、52 and 60.
Nasal polyps score score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Measured: From baseline to week 60
Time to first response (≥1 point improvement) in nasal polyps score.
Nasal polyps score score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Measured: From baseline to week 60
Change from baseline in nasal congestion score at weeks 4、8、12、16、20、28、32、36、40、44、48、52、56 and 60.
Nasal congestion score (0-3), higher score means worse nasal symptom.
Measured: From baseline to week 60
Proportion of participants with improvement by at least 1 point in nasal congestion score at weeks 4、8、12、16、20、24、28、32、36、40、44、48、52、56 and 60.
Nasal congestion score (0-3), higher score means worse nasal symptom.
Measured: From baseline to week 60
Proportion of participants with improvement by at least 2 point in nasal congestion score at weeks 4、8、12、16、20、24、28、32、36、40、44、48、52、56 and 60.
Nasal congestion score (0-3), higher score means worse nasal symptom.
Measured: From baseline to week 60
Change from baseline in Lund-Mackay score at week 24 and 52.
The range of LM score is 0-24. Higher score means worse rhinosinusitis.
Measured: From baseline to week 60
Change from baseline in 22-item Sinonasal Outcome Test (SNOT-22) at weeks 2, 4, 8, 16, 24, 32, 40, 52 and 60.
The range of SNOT-22 score is 0 to 110. Higher scores indicating more severe disease.
Measured: From baseline to week 60
Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) at weeks 2, 4, 16, 24, 32, 40, 52 and 60.
UPSIT score (0-40). Higher score means better sense of smell.
Measured: From baseline to week 60
Change from baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) at weeks 4、16、24、40、52 and 60.
The EQ-5D-5L descriptive system comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), and each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions.
Measured: From baseline to week 60
Safety parameters.
Incidence of treatment-emergent adverse events (TEAEs), incidence of treatment-emergent serious AEs (TESAEs), etc.
Measured: From baseline to week 60
Pharmacokinetics, include Ctrough, etc.
GR1802 concentrations were measured in CRSwNP population using sparse sampling (samples collected at predose, during treatment, and the follow up period).
Measured: From baseline to week 60
Pharmacodynamics.
Levels of the type 2 inflammation biomarkers were assessed as markers for disease activity/severity.
Measured: From baseline to week 60
Immunogenicity, include ADA and Nab.
Anti GR1802 antibody status was determined at baseline and at prespecified time points.
Measured: From baseline to week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start19 Sep 2024
- Primary completion12 Jun 2026
- Study completion13 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Genrix (Shanghai) Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luo Zhang, Doctor, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516302
- Sponsor's protocol ID
- GR1802-007
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy, Safety, and Immunogenicity of GR1802 in Participants With Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT06516302
- Acronym / sponsor ID
- GR1802-007
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if GR1802 works to treat severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. It will also learn about the safety of GR1802. The main questions it aims to answer are:
- Does GR1802 reduce the need for surgery and systemic corticosteroid use？
- What medical problems do participants have when taking GR1802?
Researchers will compare GR1802 to a placebo (a look-alike substance that contains no drug) to see if GR1802 works to treat CRSwNP.
Participants will:
Take GR1802 or a placebo once every 2 weeks for 13months. Visit the clinic once every 2 weeks for checkups and tests. Keep a diary of their symptoms and the dosage and number of times they use mometasone furoate nasal spray.
Detailed description
A randomized, double-blind, placebo-controlled, multi-center clinical trial was designed. The clinical trial was divided into 4 stages: screening/introduction period, double-blind treatment period , maintenance treatment period and safety follow-up period.
The clinical trial aimed to evaluate the efficacy, safety and immunogenicity of GR1802 injection in CRSwNP participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GR1802 group | Experimental | Drug: GR1802GR1802 300mg is administrated every 2 weeks (first dose doubled) for a total of 26 doses, of which an additional 2 ml of placebo is given at week 24. |
| placebo group | Placebo comparator | Drug: PlaceboPlacebo is administered every 2 weeks for the first 16 weeks. GR1802 is given every 2 weeks from week 24 to W50. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GR1802GR1802 will be administered SC. | Drug | GR1802 group |
| PlaceboThe placebo will be administered SC. | Drug | placebo group |
Primary outcome
Change from baseline in nasal polyps score at week 24.
Time frame: At week 24
Nasal polyps score score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Change from baseline in nasal congestion score at week 24.
Time frame: At week 24
Nasal congestion score (0-3), higher score means worse nasal symptom.
20 secondary outcomes
Change from baseline in reduction/loss of smell at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and 60.
Time frame: From baseline to week 60
Change from baseline in nasal discharge (anterior/posterior) at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and 60.
Time frame: From baseline to week 60
Change from baseline in Total Nasal Symptom Score (TNSS) at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and 60.
Time frame: From baseline to week 60
Change from baseline in nasal endoscopy nasal polyps score in participants with a high power field of vision < 55 eosinophil granulocytes in nasal polyp tissue at week 24.
Time frame: At week 24
Change from baseline in nasal congestion score in participants with a high power field of vision < 55 eosinophil granulocytes in nasal polyp tissue at week 24.
Time frame: At week 24
Change from baseline in nasal polyps score at weeks 2、4、8、16、32、40、52 and 60.
Time frame: From baseline to week 60
Proportion of participants with improvement by at least 1 point in nasal polyps score at weeks 2、4、8、16、24、32、40、52 and 60.
Time frame: From baseline to week 60
Proportion of participants with improvement by at least 2 point in nasal polyps score at weeks 2、4、8、16、24、32、40、52 and 60.
Time frame: From baseline to week 60
Time to first response (≥1 point improvement) in nasal polyps score.
Time frame: From baseline to week 60
Change from baseline in nasal congestion score at weeks 4、8、12、16、20、28、32、36、40、44、48、52、56 and 60.
Time frame: From baseline to week 60
Proportion of participants with improvement by at least 1 point in nasal congestion score at weeks 4、8、12、16、20、24、28、32、36、40、44、48、52、56 and 60.
Time frame: From baseline to week 60
Proportion of participants with improvement by at least 2 point in nasal congestion score at weeks 4、8、12、16、20、24、28、32、36、40、44、48、52、56 and 60.
Time frame: From baseline to week 60
Change from baseline in Lund-Mackay score at week 24 and 52.
Time frame: From baseline to week 60
Change from baseline in 22-item Sinonasal Outcome Test (SNOT-22) at weeks 2, 4, 8, 16, 24, 32, 40, 52 and 60.
Time frame: From baseline to week 60
Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) at weeks 2, 4, 16, 24, 32, 40, 52 and 60.
Time frame: From baseline to week 60
Change from baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) at weeks 4、16、24、40、52 and 60.
Time frame: From baseline to week 60
Safety parameters.
Time frame: From baseline to week 60
Pharmacokinetics, include Ctrough, etc.
Time frame: From baseline to week 60
Pharmacodynamics.
Time frame: From baseline to week 60
Immunogenicity, include ADA and Nab.
Time frame: From baseline to week 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luo Zhang, Doctor principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GR1802 in people with Chronic Rhinosinusitis With Nasal Polyps, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in nasal polyps score at week 24. (time frame: At week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.