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

NCT05324137 | Completed Phase 1

• 1 other identifier: CM326NP001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (2)

• Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

  Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

  up to Week 64

• Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 16.

  NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.

  at week 16

Secondary Outcomes (10)

• PK: Concentration of CM326 in plasma

  up to Week 64

• Immunogenicity: anti-drug antibody (ADA)

  up to Week 64

• PD: Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration.

  up to Week 64

• PD: Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration.

  up to Week 64

• PD: Changes from baseline in plasma interleukin-5 (IL-5) after CM326 administration

  up to Week 64

Study Arms (4)

Group 1: 55mg Q2W

EXPERIMENTAL

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

Drug: CM326; Other: Placebo

Group 2: 110mg Q2W

EXPERIMENTAL

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

Drug: CM326; Other: Placebo

Group 3: 220mg Q2W

EXPERIMENTAL

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

Drug: CM326; Other: Placebo

Group 4: 220mg Q4W

EXPERIMENTAL

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

Drug: CM326; Other: Placebo

Interventions

CM326 DRUG

CM326 injection

Group 1: 55mg Q2W; Group 2: 110mg Q2W; Group 3: 220mg Q2W; Group 4: 220mg Q4W

Placebo OTHER

Placebo

Group 1: 55mg Q2W; Group 2: 110mg Q2W; Group 3: 220mg Q2W; Group 4: 220mg Q4W

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Location

Related Publications (2)

• 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.

  PMID: 41022848 DERIVED

• 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.

  PMID: 38482462 DERIVED

Study Officials

• Luo Zhang

  Beijing Tong-Ren hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 12, 2022
• Study Start: July 11, 2022
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-03

Locations

CN (1)