A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps

NCT ID: NCT05324137

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-11
• Study Completion Date: 2024-03-29

Brief Summary

This is a multi-center, randomized, double blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of CM326 in patients with chronic rhinosinusitis with nasal polyps.

Detailed Description

The study consists of 3 periods, a Screening Period, a Treatment Period and a Safety Follow-up Period.

Subjects who meet eligibility criteria will be randomized to receive either CM326 or placebo subcutaneously.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: 55mg Q2W

CM326 55 mg or matched placebo, every 2 weeks, subcutaneous (SC)

Group Type: EXPERIMENTAL

CM326

Intervention Type: DRUG

CM326 injection

Placebo

Intervention Type: OTHER

Placebo

Group 2: 110mg Q2W

CM326 110 mg or matched placebo, every 2 weeks, subcutaneous (SC)

Group Type: EXPERIMENTAL

CM326

Intervention Type: DRUG

CM326 injection

Placebo

Intervention Type: OTHER

Placebo

Group 3: 220mg Q2W

CM326 220 mg or matched placebo, every 2 weeks, subcutaneous (SC)

Group Type: EXPERIMENTAL

CM326

Intervention Type: DRUG

CM326 injection

Placebo

Intervention Type: OTHER

Placebo

Group 4: 220mg Q4W

CM326 220mg or matched placebo, every 4 weeks, subcutaneous (SC)

Group Type: EXPERIMENTAL

CM326

Intervention Type: DRUG

CM326 injection

Placebo

Intervention Type: OTHER

Placebo

Interventions

CM326

CM326 injection

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects who are capable of understanding the nature of the study and voluntarily signing the ICF.
• Male or female subjects, aged between 18 and 70 years old (inclusive), with a body mass index (BMI) ≥ 19 kg/m2.
• Diagnosed with Chronic Rhinosinusitis With Nasal Polyps.
• The total NPS score should be at least 3 points, with at least 1 point in each side of the nasal cavity.
• Prior treatment with systemic corticosteroids (SCS) within two years before screening, and/or contraindicate to or intolerance to systemic corticosteroids, and/or with prior surgery to nasal polyps 6 months before the screening.
• Ongoing symptoms for at least 4 weeks before screening：1) Nasal congestion/obstruction; 2) Other symptom, e.g., loss of smell or rhinorrhea.

Exclusion Criteria

• Allergic or intolerant to mometasone furoate spray or CM326/placebo.
• Have used of systemic immunosuppressants for inflammatory or autoimmune diseases within 8 weeks or 5 half-lives prior to randomization.
• Have initiated leukotriene receptor antagonist therapy within 4 weeks prior to randomization.
• have received allergen-specific immunotherapy that initiated within 3 months prior to randomization or planned to be initiated during the study period.
• Have undergone nasal surgery (including nasal polypectomy) within 6 months prior to screening.
• Have received medium- and short-acting systemic corticosteroids (including oral, intravenous, intramuscular corticosteroids), nasal dripping corticosteroids, traditional Chinese medicine (including systemic and local herbal products preparations) for chronic rhinosinusitis (CRS) within 4 weeks prior to screening, or long-acting systemic corticosteroids.
• With concomitant asthma (including suspected diagnosis of asthma) will be excluded if they meet the following conditions: predicted FEV1 of≤ 60%, or acute exacerbation of asthma within 3 months prior to screening requiring SCS or hospitalization (> 24 hours), or using inhaled corticosteroids (ICS) of > 1000 μg fluticasone propionate or others at equivalent doses
• With antrochoanal polyps.
• With severe deviation of the nasal septum occludes at least one nostril.
• With persistent rhinitis medicamentosas.
• With allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, cystic fibrosis.
• With acute sinusitis, nasal infection, or upper respiratory tract infection at screening.
• Have symptoms or whose CT scan suggests allergic fungal sinusitis.
• With malignant or benign neoplasm of nasal cavities.
• With other uncontrolled serious diseases or recurrent chronic diseases.
• Have severe hepatic and renal impairment.
• Have received live attenuated vaccines within 12 weeks prior to randomization, or during the planned study; or have received inactivated vaccines (e.g., novel coronavirus vaccines) within 30 days prior to randomization.
• With known or suspected immunosuppression, including, but not limited to, the history of invasive opportunistic infections.
• Subjects who are pregnant or planning to become pregnant, or breastfeeding during the study.
• With a history of large alcohol consumption or a history of drug abuse within 3 months prior to screening.
• With other medical or non-medical conditions that are not suitable for participation in the study in the opinion of the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luo Zhang

Role: PRINCIPAL_INVESTIGATOR

Beijing Tong-Ren hospital

Locations

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Countries

China

References

Xian M, Lan F, Yan B, Shen S, Liu S, Wan L, Song X, Jiang L, Jiang Y, Xue J, Chen J, Su L, Ye J, Yang Y, Fang H, Tan G, Zhang Q, Qu S, Wei X, Luo X, Xu Y, Yu S, Xiao Z, Liu F, Li Q, Zhang Y, Xie Y, Wang L, Yang G, Yan H, Zhao G, Chen B, Wang C, Zhang L. An anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial. Nat Commun. 2025 Sep 29;16(1):8607. doi: 10.1038/s41467-025-63682-x.

Reference Type: DERIVED

PMID: 41022848 (View on PubMed)

Shen S, Xian M, Yan B, Lan F, Wang C, Zhang L. Anti-thymic stromal lymphopoietin monoclonal antibody in patients with chronic rhinosinusitis with nasal polyps (DUBHE): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled study. Asia Pac Allergy. 2024 Mar;14(1):26-31. doi: 10.5415/apallergy.0000000000000135. Epub 2024 Jan 25.

Reference Type: DERIVED

PMID: 38482462 (View on PubMed)

Other Identifiers

CM326NP001

Identifier Type: -

Identifier Source: org_study_id