Chronic Rhinosinusitis With Nasal PolyposisPhase 2NCT06930612
A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-1）
A Phase 2 study testing CM512 in people with Chronic Rhinosinusitis With Nasal Polyposis, run by Beijing Keymed Biosciences Co., Ltd. at 1 site in China.
Trial summary
This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyposis
- What is being tested?
- CM512
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2025to 10 Jul 2026
- Phase
- Phase 2
- 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
- with chronic rhinosinusitis with nasal polyposis (CRSwNP).
- Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity.
- Nasal Congestion Score of 2 or 3 at screening period, and at least 2 at baseline.
- Contraception.
Who cannot join
- Not enough washing out period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for Interleukin (IL)-4 receptor alpha subunit antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity.
- Vaccination with live attenuated vaccine within 30 days before randomization or during the planned study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis
This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
Read the detailed description
The study consists of a Screening Period (up to 4 weeks), Treatment Period (24 weeks for double-blind treatment period) and Safety Follow-up Period (12 weeks).
- Being tested
- CM512, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM512Biological
Administered subcutaneous injection
PlaceboDrug
Administered subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| CM512 Dose 1 | Experimental | Not described Receives: Biological: CM512 |
| CM512 Dose 2 | Experimental | Not described Receives: Biological: CM512 |
| CM512 Dose 3 | Experimental | Not described Receives: Biological: CM512 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Polyps Score (NPS)
Change from baseline in the Nasal Polyps Score (NPS) at week 24. NPS score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Measured: at week 24
Secondary outcomes (25)
Change from baseline in NPS at other visits
Measured: baseline up to week 36
Change from baseline in Nasal Congestion Score (NCS) at each visit
Measured: baseline up to week 36
Proportion of participants achieving an improvement in NPS from baseline of ≥ 1 point and ≥ 2 points at each visit
Measured: baseline up to week 36
Change from baseline in Total Symptom Score (TSS) at each visit
Measured: baseline up to week 36
Change from baseline in Loss of Smell (LoS) score at each visit
Measured: baseline up to week 36
Change from baseline in Lund-Mackay (LMK) score evaluated by sinus computed tomography (CT) at each visit
Measured: baseline up to week 36
Change from baseline in 22-item Sino-nasal Outcome Test (SNOT-22) score at each visit
Measured: baseline up to week 36
Incidence of treatment-emergent adverse events (TEAEs)
Measured: baseline up to week 36
physical examination
Measured: baseline up to week 36
vital signs
Measured: baseline up to week 36
12-lead electrocardiogram (ECG)
Measured: baseline up to week 36
clinical laboratory tests
Measured: baseline up to week 36
Concentration of CM512 in serum
Measured: baseline up to week 36
Change from baseline and percent change from baseline in serum total immunoglobulin E (IgE) level at each visit
Measured: baseline up to week 36
Change from baseline and percent change from baseline in peripheral blood eosinophil (EOS) level at each visit
Measured: baseline up to week 36
Change from baseline and percent change from baseline in serum interleukin-5 (IL-5) level at each visit
Measured: baseline up to week 36
Change from baseline and percent change from baseline in serum interleukin-13 (IL-13) level at each visit
Measured: baseline up to week 36
Change from baseline and percent change from baseline in serum thymic stromal lymphopoietin (TSLP) level at each visit
Measured: baseline up to week 36
Change from baseline and percent change from baseline in serum thymus and activation-regulated chemokine (TARC) level at each visit
Measured: baseline up to week 36
Change from baseline and percent change from baseline in serum eotaxin-3 level at each visit
Measured: baseline up to week 36
Change from baseline and percent change from baseline in serum chemokine 13 (CCL13) level at each visit
Measured: baseline up to week 36
Change from baseline and percent change from baseline in serum chemokine 22 (CCL22) level at each visit
Measured: baseline up to week 36
Change from baseline and percent change from baseline in serum periostin level at each visit.
Measured: baseline up to week 36
Change from baseline and percent change from baseline in EOS levels in nasal polyp biopsy tissue
Measured: baseline up to week 24
Incidence of Anti-drug antibodies (ADA)
Measured: baseline up to week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start16 May 2025
- Primary completion20 Apr 2026
- Study completion10 Jul 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 PolyposisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Keymed Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luo Zhang, Principal investigator, Beijing Tong-Ren hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930612
- Sponsor's protocol ID
- CM512-102101
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis
- ClinicalTrials.gov ID
- NCT06930612
- Acronym / sponsor ID
- CM512-102101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Beijing Keymed Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 May 2025 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 16 Apr 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.
This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
Detailed description
The study consists of a Screening Period (up to 4 weeks), Treatment Period (24 weeks for double-blind treatment period) and Safety Follow-up Period (12 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CM512 Dose 1 | Experimental | Biological: CM512 |
| CM512 Dose 2 | Experimental | Biological: CM512 |
| CM512 Dose 3 | Experimental | Biological: CM512 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- with chronic rhinosinusitis with nasal polyposis (CRSwNP).
- Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity.
- Nasal Congestion Score of 2 or 3 at screening period, and at least 2 at baseline.
- Contraception.
Key exclusion criteria (2 listed)
- Not enough washing out period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for Interleukin (IL)-4 receptor alpha subunit antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity.
- Vaccination with live attenuated vaccine within 30 days before randomization or during the planned study period.
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 |
|---|---|---|
| CM512Administered subcutaneous injection | Biological | CM512 Dose 1, CM512 Dose 2, CM512 Dose 3 |
| PlaceboAdministered subcutaneous injection | Drug | Placebo |
Primary outcome
Nasal Polyps Score (NPS)
Time frame: at week 24
Change from baseline in the Nasal Polyps Score (NPS) at week 24. NPS score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
25 secondary outcomes
Change from baseline in NPS at other visits
Time frame: baseline up to week 36
Change from baseline in Nasal Congestion Score (NCS) at each visit
Time frame: baseline up to week 36
Proportion of participants achieving an improvement in NPS from baseline of ≥ 1 point and ≥ 2 points at each visit
Time frame: baseline up to week 36
Change from baseline in Total Symptom Score (TSS) at each visit
Time frame: baseline up to week 36
Change from baseline in Loss of Smell (LoS) score at each visit
Time frame: baseline up to week 36
Change from baseline in Lund-Mackay (LMK) score evaluated by sinus computed tomography (CT) at each visit
Time frame: baseline up to week 36
Change from baseline in 22-item Sino-nasal Outcome Test (SNOT-22) score at each visit
Time frame: baseline up to week 36
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: baseline up to week 36
physical examination
Time frame: baseline up to week 36
vital signs
Time frame: baseline up to week 36
12-lead electrocardiogram (ECG)
Time frame: baseline up to week 36
clinical laboratory tests
Time frame: baseline up to week 36
Concentration of CM512 in serum
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum total immunoglobulin E (IgE) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in peripheral blood eosinophil (EOS) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum interleukin-5 (IL-5) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum interleukin-13 (IL-13) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum thymic stromal lymphopoietin (TSLP) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum thymus and activation-regulated chemokine (TARC) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum eotaxin-3 level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum chemokine 13 (CCL13) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum chemokine 22 (CCL22) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum periostin level at each visit.
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in EOS levels in nasal polyp biopsy tissue
Time frame: baseline up to week 24
Incidence of Anti-drug antibodies (ADA)
Time frame: baseline up to week 36
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 18 Aug 2026.
Related trials for Chronic Rhinosinusitis With Nasal Polyposis
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Recruiting
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
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 principal investigator
Beijing Tong-Ren hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CM512 in people with Chronic Rhinosinusitis With Nasal Polyposis, run by Beijing Keymed Biosciences 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 2 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 18 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Nasal Polyps Score (NPS) (time frame: at week 24). 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 18 Aug 2026.