Chronic Rhinosinusitis With Nasal PolypsPhase 3NCT07132827
Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps
A Phase 3 study testing SHR-1905 Injection in people with Chronic Rhinosinusitis With Nasal Polyps, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) 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?
- SHR-1905 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2025to Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Weight ≥40kg
- Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP).
- Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril.
- NCS ≥2 at screening and baseline.
- SNOT-22≥30 at screening period and baseline.
- Recorded persistent NP symptoms for over 4 weeks prior to screening.
- Subjects received standard therapy with intranasal corticosteroids (INCS) prior to randomization.
- NP surgery in the past and/or SCS use within 1 years before screening(or with contraindications/ intolerances).
Who cannot join
- Any comorbidities that may affect the efficacy evaluation of nasal polyps.
- Any comorbidities except for asthma that may affect blood EOS levels.
- Concomitant with immunodeficiency.
- Concomitant with contraindications or not suitable for nasal endoscopy.
- Uncontrolled hypertension and/or uncontrolled diabetes.
- Concomitant with infection within 4 weeks prior to randomization.
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- Uncontrolled epistaxis within 4 weeks prior to randomization.
- Major surgery performed within 3 months prior to randomization, or surgery planned during the study, or treatments that may affect evaluations according to investigators.
- Parasitic infection within 6 months before randomization.
- Sinus or intranasal surgery within 6 months prior to screening, or changes in the nasal walls caused by sinus or intranasal surgery that made NPS evaluation impossible.
- Malignancies diagnosed within 5 years before randomization (except those with a low risk of metastasis or death).
- Abnormalities of laboratory tests at screening or baseline.
- Concomitant with active hepatitis B, positive hepatitis C virus antibodies, positive human immunodeficiency virus antibodies, or positive treponema pallidum antibodies.
- Prolonged QTc interval or other clinically significant abnormal results of ECG at screening or baseline that may cause significant safety risks to subjects.
- FEV1 before the use of bronchodilator (pre-BD) was less than 50% at screening.
- Transfusion of blood products or immunoglobulin within 4 weeks prior to randomization.
- SCS or additional INCS use within 4 weeks before randomization, or planned use during treatment period.
- Regular use of decongestants (local or systemic) within 4 weeks before randomization, except for during the endoscopic procedure.
- Adnimistration of live vaccine or viral vector vaccine within 4 weeks before randomization.
- Allergen immunotherapy within 8 weeks before randomization.
- Smoking at screening, or smoking cessation less than 6 months at screening.
- Substance abuse, drug abuse, and/or excessive alcohol consumption within 1 year prior to randomization.
- Pregnancy (including positive pregnancy test at screening or baseline), lactation, or pregnancy plan during study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye & Ent Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Dehui Wang
About this study
Official title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Efficacy and Safety Study of SHR-1905 in Patiens With Chronic Rhinosinusitis With Nasal Polyps
The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP)
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- SHR-1905 Injection, SHR-1905 Placebo Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1905 InjectionDrug
SHR-1905 Injection
SHR-1905 Placebo InjectionDrug
SHR-1905 Placebo Injection
| Study group | Role | What they receive |
|---|---|---|
| SHR-1905 Injection | Experimental | Not described Receives: Drug: SHR-1905 Injection |
| SHR-1905 Placebo Injection | Placebo comparator | Not described Receives: Drug: SHR-1905 Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal polyp scores (NPS)
Change from baseline in NPS at Week 24.
Measured: Baseline to Week 24
Nasal Congestion Scores (NCS)
from baseline in NPS at Week 24.
Measured: Baseline to Week 24
Secondary outcomes (5)
Lund Mackay score (LMK) from baseline on sinus CT scan
Measured: Baseline to Week 24
Loss of smell
Measured: Baseline to Week 24
Proportion of subjects with NPS≤1 point per nostril
Measured: Baseline to Week 24
Sino-nasal outcome test-22 (SNOT-22) scores
Measured: Baseline to Week 24
Total symptoms score (TSS)
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start28 Aug 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
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 Guangdong Hengrui Pharmaceutical Co., LtdThe 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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132827
- Sponsor's protocol ID
- SHR-1905-301
- Status last verified
- Jun 2025
- First submitted
- 13 Aug 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Efficacy and Safety Study of SHR-1905 in Patiens With Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT07132827
- Acronym / sponsor ID
- SHR-1905-301
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 20 Aug 2025 (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 study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP)
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 |
|---|---|---|
| SHR-1905 Injection | Experimental | Drug: SHR-1905 Injection |
| SHR-1905 Placebo Injection | Placebo comparator | Drug: SHR-1905 Placebo Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Weight ≥40kg
- Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP).
- Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril.
- NCS ≥2 at screening and baseline.
- SNOT-22≥30 at screening period and baseline.
Key exclusion criteria (23 listed)
- Any comorbidities that may affect the efficacy evaluation of nasal polyps.
- Any comorbidities except for asthma that may affect blood EOS levels.
- Concomitant with immunodeficiency.
- Concomitant with contraindications or not suitable for nasal endoscopy.
- Uncontrolled hypertension and/or uncontrolled diabetes.
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 |
|---|---|---|
| SHR-1905 InjectionSHR-1905 Injection | Drug | SHR-1905 Injection |
| SHR-1905 Placebo InjectionSHR-1905 Placebo Injection | Drug | SHR-1905 Placebo Injection |
Primary outcome
Nasal polyp scores (NPS)
Time frame: Baseline to Week 24
Change from baseline in NPS at Week 24.
Nasal Congestion Scores (NCS)
Time frame: Baseline to Week 24
from baseline in NPS at Week 24.
5 secondary outcomes
Lund Mackay score (LMK) from baseline on sinus CT scan
Time frame: Baseline to Week 24
Loss of smell
Time frame: Baseline to Week 24
Proportion of subjects with NPS≤1 point per nostril
Time frame: Baseline to Week 24
Sino-nasal outcome test-22 (SNOT-22) scores
Time frame: Baseline to Week 24
Total symptoms score (TSS)
Time frame: Baseline to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 SHR-1905 Injection in people with Chronic Rhinosinusitis With Nasal Polyps, run by Guangdong Hengrui Pharmaceutical 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 8 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HuanHuan Huang (+0518-81220121, huanhuan.huang.hh30@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal polyp scores (NPS) (time frame: Baseline to 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 17 Nov 2025.