Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)Phase 3NCT07807826
A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis (NEZHA-3)
A Phase 3 study testing CM512 in people with Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP), 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 III 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 (CRSwNP)
- 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
- 240 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Jul 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
- 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 systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity
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
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality
Luo Zhang, 028-88610620, clinicaltrial@keymedbio.com
Chengshuo wang, 028-88610620, clinicaltrial@keymedbio.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyps
This is a multi-center, randomized, double blind, placebo-controlled Phase III 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
This study consists of a screening/run-in period (up to 4 weeks), a treatment period (24-week double-blind treatment period + 24-week maintenance treatment period), and a 12-week safety follow-up period.
- Being tested
- CM512, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM512Biological
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| CM512 group | Experimental | Not described Receives: Biological: CM512 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Change from baseline in the Nasal Congestion Score (NCS) at week 24
Congestion Score is scored on a scale of 0 to 3.higher score means a worse outcome.
Measured: At week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionJul 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 Polyposis (CRSwNP)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Keymed Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807826
- Sponsor's protocol ID
- CM512-102206
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT07807826
- Acronym / sponsor ID
- CM512-102206
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing Keymed Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 8 Sep 2026 (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 III 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
This study consists of a screening/run-in period (up to 4 weeks), a treatment period (24-week double-blind treatment period + 24-week maintenance treatment period), and a 12-week safety follow-up period.
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 |
|---|---|---|
| CM512 group | Experimental | Biological: CM512 |
| Placebo group | 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 (1 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 systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity
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 |
|---|---|---|
| CM512subcutaneous injection | Biological | CM512 group |
| Placebosubcutaneous injection | Drug | Placebo group |
Primary outcome
Change from baseline in the Nasal Polyps Score (NPS) at week 24
Time frame: At week 24
NPS score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Change from baseline in the Nasal Congestion Score (NCS) at week 24
Time frame: At week 24
Congestion Score is scored on a scale of 0 to 3.higher score means a worse outcome.
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 8 Sep 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.
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 CM512 in people with Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP), 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 1 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: opening soon, as of the sponsor's last update on 8 Sep 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?
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 Qian Jia (028-88610620, clinicaltrial@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Nasal Polyps Score (NPS) 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 8 Sep 2026.