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Chronic Rhinosinusitis With Nasal PolypsPhase 3NCT07420257

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis

A Phase 3 study testing CM326 injection in people with Chronic Rhinosinusitis With Nasal Polyps, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and I immumogenicity[c2.1] of CM326 in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).The study consists of four… 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?
CM326 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
212 participants
Where
No sites listed yet
Study dates
28 Feb 2026to 30 Oct 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

  • Understand the study and voluntarily sign the informed consent form.
  • Age between 18 and 75 years (inclusive) at the time of informed consent signing, regardless of gender.
  • Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) meeting the diagnostic criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2024)".
  • Meet at least 1 of the following 4 items: a. Received SCS treatment for at least 3 consecutive days within 2 years prior to screening; b. Received at least one long-acting SCS (such as triamcinolone acetonide injection) within 2 years prior to screening; c. Had [c8.1]contraindications to SCS treatment or intolerance to SCS treatment; d. Received nasal polyp surgery more than 6 months prior to screening.
  • Concurrent presence of the following symptoms for ≥[c9.1]8 weeks prior to the screening/run-in period: a. nasal congestion; b. Any[c10.1] other symptom such as hyposmia/loss of smell or rhinorrhea
  • Stable dose of intranasal corticosteroids (INCS) for >4 weeks prior to screening (participants using non-mometasone furoate nasal spray [MFNS] products must agree to switch to Mometasone Furoate Nasal Spray (MFNS) during the study). The evaluation during the lead-in period showed that the medication adherence to intranasal mometasone furoate nasal spray (MFNS) was greater than 70%.
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  • Bilateral Nasal Polyp Score (NPS) ≥5 (maximum score 8) with ≥2 points per nostril, as assessed by nasal endoscopy during screening and before randomization.
  • Nasal Congestion Score (NCS) ≥2 at the screening visit and before randomization(weekly average score).[c11.1][11.2]
  • 22-item Sino-Nasal Outcome Test (SNOT-22) score ≥30 at screening and before randomization.
  • Eligible participants of childbearing potential (males and females) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence, etc.) with their partners during the trial and for 3 months after the last dose; Females of childbearing potential must be non-lactating, have a negative blood pregnancy test at screening, and have a negative blood or urine pregnancy test before randomization.

Who cannot join

  • Presence of nasal conditions affecting NPS evaluation, including but not limited to: a. Antrochoanal polyps; b. Nasal septum perforation or severe nasal septum deviation occluding at least one nostril; c. Nasal surgery that alters the structure of the lateral nasal wall precluding completion of the NPS assessment.
  • Clinically significant comorbidities other than asthma that may affect the efficacy assessment or interfere with the interpretation of the efficacy assessment results, including but not limited to: a. Allergic granulomatosis with polyangiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), allergic bronchopulmonary mycosis, and eosinophilic esophagitis; b. Bronchiectasis, pulmonary fibrosis, cystic fibrosis; c. Primary ciliary dyskinesia, Young's syndrome, Kartagner's syndrome, or other ciliary dyskinesia syndromes; d. Acute sinusitis, nasal infection, or upper respiratory tract infection at the time of the screening visit or within 2 weeks prior to the screening visit; e. Persistent rhinitis medicamentosa; f. Imaging suspected or confirmed fungal sinusitis; g. Malignant or benign tumors of the nasal cavity or paranasal sinuses.
  • Uncontrolled epistaxis within 2 months prior to screening;
  • Concomitant major chronic diseases that are uncontrolled and that, in the opinion of the investigator, may increase the safety risk of the participant's participation in this study;
  • Participants with other concomitant active or clinically significant respiratory diseases that may significantly affect the study, as judged by the investigator;
  • Participants with cardiovascular disease, and whose participation in this trial may affect the safety of the participants or the analysis of the study results at the discretion of the investigator.
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  • Active malignancy of any type or history of malignancy;
  • Infection requiring systemic antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal treatment within 14 days prior to screening; Diagnosed with helminthic parasitic infection within 6 months prior to screening and untreated or refractory to standard therapy;
  • History of active pulmonary tuberculosis within 12 months prior to screening, or old tuberculosis with high risk of recurrence as assessed by the investigator;
  • Known or suspected history of immunosuppression, immune dysfunction or immune dysregulation, including but not limited to invasive opportunistic infections even if the infection has resolved, history of splenectomy, primary immunodeficiency, etc.; or unusually frequent, recurrent, or prolonged infections as judged by the investigator;
  • Participants with comorbid asthma who have any of the following conditions: a. FEV1 ≤ 50% of the predicted normal value during the screening period and before baseline; b. Asthma exacerbation within 90 days prior to screening; c. Participants who are currently using inhaled corticosteroids at a daily dose higher than 1000 μg of fluticasone or equivalent, or who have started inhaled corticosteroids within 4 weeks prior to screening;
  • Nasal surgery within 6 months prior to screening;
  • Received medium- or short-acting SCS (including oral, intravenous, or intramuscular glucocorticoids) or traditional Chinese medicine (including systemic and topical traditional Chinese medicine preparations) for the treatment of chronic sinusitis within 4 weeks prior to screening, or received long-acting SCS (such as triamcinolone acetonide injection) within 6 weeks prior to screening, or plan to receive the above drugs during the study; Use of glucocorticoid-eluting intranasal stents within 6 months prior to screening;
  • Patients who have received treatment with other biological agents other than anti-TSLP monoclonal antibodies, including but not limited to IL-4Rα monoclonal antibodies and anti-IgE monoclonal antibodies, within 8 weeks or 5 half-lives (whichever is longer) prior to screening;
  • Previous treatment with anti-TSLP monoclonal antibody;
  • Received systemic immunosuppressant therapy within 8 weeks or 5 half-lives (whichever is longer) prior to screening;
  • Treatment with leukotriene receptor antagonists within 4 weeks before baseline;
  • Regular use of decongestants (topical or systemic) within 4 weeks prior to screening, except for short-term use for endoscopy;
  • Initiation of allergen-specific immunotherapy (desensitization therapy) within 3 months prior to baseline, or planned initiation of such therapy during the study period;
  • Treatment with immunoglobulin or blood products within 30 days prior to screening;
  • Any of the following infectious disease screening indicators meet the following criteria at screening: a. HBsAg positive or HBcAb positive and HBV-DNA positive; Patients who have received antiviral therapy in the past need to be excluded even if HBV-DNA is negative; b. HCV antibody positive and HCV-RNA positive. Patients who have received previous treatment for hepatitis C should still be excluded even if HCV-RNA is negative; c. Positive Treponema pallidum antibody test (if the Treponema pallidum particle agglutination test is positive, RPR or TRUST for syphilis is required. If the RPR or TRUST test is negative and the investigator judges that the participant has been infected with syphilis in the past but has been cured, he or she is eligible for inclusion); d. Human immunodeficiency virus antibody (Anti-HIV) positive.
  • Clinically[c12.1] significant laboratory abnormalities that, in the opinion of the investigator, pose a risk to or affect the participant's participation in the study; Or meet any of the following criteria: a. Glutamate aminotransferase or aspartate aminotransferase >2.5×ULN; b. Total bilirubin and/or direct bilirubin >2×ULN; c. Absolute neutrophil count <1.5×10^9/L; d. Serum creatinine >1.5×ULN.
  • Clinically significant abnormal findings found during the screening period, including physical examination, vital signs, 12-lead ECG, etc., which in the opinion of the investigator will pose a risk or affect the participant's participation in the study;
  • Hypersensitivity to MFNS or CM326; History of severe systemic allergy to any biologic agent (except local injection site reaction);
  • History of drug abuse, narcotics, and/or excessive alcohol consumption within 6 months prior to screening, as assessed by the investigator;
  • Current smokers or participants with a smoking history of ≥10 pack-years;
  • Vaccination with a live attenuated vaccine within 30 days prior to randomization or planned vaccination with a live attenuated vaccine during the study;
  • Use of any other clinical study drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to screening; Or still participating in or planning to participate in other clinical trials;
  • As assessed by the investigator, the participant's poor compliance with this study (such as a clear history of mental disorder) makes it impossible to complete the study;
  • Other medical or non-medical conditions that, in the opinion of the investigator, make the participant unsuitable for participation in this study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

031169085587

ctr-contact@cspc.cn

About this study

This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and I immumogenicity[c2.1] of CM326 in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).The study consists of four periods, including an up to 4-week screening/run-in period, a 24-week double-blind randomized treatment period, a 28-week open-label treatment period, and an 8-week safety follow-up period.

Being tested
CM326 injection, Placebo of CM326
Keywords
CM326，anti-TSLP biologics, Chronic rhinosinusitis with nasal polyps，allergy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CM326 injectionBiological

    CM326 injection, administered subcutaneously, once every 4 weeks

  • Placebo of CM326Drug

    Placebo of CM326, administered subcutaneously, once every 4 weeks

Study groups in NCT07420257
Study groupRoleWhat they receive
CM326ExperimentalCM326 subcutaneous (SC)
Receives: Biological: CM326 injection
Placebo of CM326Placebo comparatorPlacebo of CM326, subcutaneous (SC)
Receives: Drug: Placebo of CM326

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Nasal Polyp Score(NPS) at week 24

    Change from baseline in Nasal Polyp Score(NPS) at week 24. The NPS will be assessed through centralized image review by a third-party institution.

    Measured: 24 weeks

  2. Change of Nasal Congestion Score(NCS) at week 24

    Change of Nasal Congestion Score(NCS) at week 24. The NCS will be collected via patient-reported electronic diary.

    Measured: 24 weeks

Secondary outcomes (14)

  1. Change from baseline in Nasal Polyp Score(NPS) at each predefined time point

    Change from baseline in Nasal Polyp Score(NPS) at each predefined time point. The NPS will be assessed through centralized image review by a third-party institution.

    Measured: 60 weeks

  2. Change of Nasal Congestion Score(NCS) at each predefined time point.

    Change from baseline in Nasal Congestion Score(NCS) at each predefined time point.The NCS will be collected via patient-reported electronic diary.

    Measured: 60 weeks

  3. Proportions of participants with an improvement of ≥1 point and ≥2 points in NPS

    Proportions of participants with an improvement of ≥1 point and ≥2 points in NPS compared to the baseline at Week 24 and Week 52

    Measured: 24 weeks and 52 weeks

  4. Proportions of participants with the NPS of no more than 1 point in each nasal cavity

    Proportions of participants with NPS of no more than 1 point in each nasal cavity at Week 24 and Week 52

    Measured: 24 weeks and 52 weeks

  5. Change from baseline in Total Symptom Score(TSS) at each predefined time point

    Change from baseline in Total Symptom Score(TSS) at each predefined time point. The TSS will be collected via patient-reported electronic diary.

    Measured: 60 weeks

  6. Change from baseline in the loss-of-smell score at each predefined time point

    Change from baseline in the loss-of-smell score at each predefined time point. The loss-of-smell score will be collected via patient-reported electronic diary.

    Measured: 60 weeks

  7. Change from baseline in the 22-item Sino-Nasal Outcome Test(SNOT-22) score at each predefined time point

    Change from baseline in the 22-item Sino-Nasal Outcome Test(SNOT-22) score at each predefined time point.

    Measured: 60 weeks

  8. Change from baseline in Lund-Mackay score at Week 24 and Week 52.

    Change from baseline in Lund-Mackay score at Week 24 and Week 52.The Lund-Mackay score will be assessed based on the sinus CT scan of the participants.

    Measured: 24 weeks and 52 weeks

  9. Proportions of participants receiving[c6.1][6.2] systemic corticosteroid(SCS) or nasal polyp surgery for rescue therapy

    Proportions of participants receiving[c7.1] systemic corticosteroid(SCS) or nasal polyp surgery for rescue therapy within the 24-week double-blind treatment period and throughout the study.

    Measured: 24 weeks and 60 weeks

  10. Time to the first use of SCS or nasal polyp surgery for rescue therapy.

    Time to the first use of SCS or nasal polyp surgery for rescue therapy within the 24-week double-blind treatment period and throughout the study.

    Measured: 24 weeks and 60 weeks

  11. Incidence and severity of Adverse events (AEs)

    The severity of adverse events is recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0. The incidence of participants with adverse events (AE) will be calculated.

    Measured: 60 weeks

  12. Blood drug concentration of CM326

    Measured: 60 weeks

  13. Change from baseline in the PD markers at each predefined time point

    Change from baseline in the PD markers at each predefined time point. The PD markers includes the peripheral blood eosinophil counts, the concentrations of IgE，, IL-5 and IL-13 in the peripheral blood.

    Measured: 60 weeks

  14. Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies(Nab)

    Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies(Nab)

    Measured: 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start28 Feb 2026 (estimated)
  3. Primary completion30 Oct 2028 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

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
Model description
This is a randomized, double-blind, placebo-controlled, multicenter Phase III study. The study will last approximately 64 weeks, divided into a screening/run-in period (up to 4 weeks), a double-blind treatment period (24 weeks), an open-label treatment period (28 weeks), and a safety follow-up period (8 weeks)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07420257
Sponsor's protocol ID
CM326-005
Status last verified
Feb 2026
First submitted
12 Feb 2026
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CM326 injection in people with Chronic Rhinosinusitis With Nasal Polyps, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd..

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 10 inclusion and 30 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Nasal Polyp Score(NPS) at week 24 (time frame: 24 weeks). 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?

On the ClinicalTrials.gov record for NCT07420257.

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 19 Feb 2026.

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