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

NCT07420257 | Not Yet Recruiting Phase 3

• 1 other identifier: CM326-005
• Study Type: interventional
• Target: 212
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Keywords

CM326，anti-TSLP biologics, Chronic rhinosinusitis with nasal polyps，allergy

Outcome Measures

Primary Outcomes (2)

• 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.

  24 weeks

• 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.

  24 weeks

Secondary Outcomes (14)

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

  60 weeks

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

  60 weeks

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

  24 weeks and 52 weeks

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

  24 weeks and 52 weeks

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

  60 weeks

Study Arms (2)

CM326

EXPERIMENTAL

CM326 subcutaneous (SC)

Biological: CM326 injection

Placebo of CM326

PLACEBO COMPARATOR

Placebo of CM326, subcutaneous (SC)

Drug: Placebo of CM326

Interventions

CM326 injection BIOLOGICAL

CM326 injection, administered subcutaneously, once every 4 weeks

CM326

Placebo of CM326 DRUG

Placebo of CM326, administered subcutaneously, once every 4 weeks

Placebo of CM326

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.
• 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).\[c11.1\]\[11.2\]
• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: lead

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02