Study of CM310 in Subjects With Allergic Rhinitis

NCT05908032 | Completed Phase 3

• 1 other identifier: CM310-107206
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study aimed at evaluating the efficacy and safety of CM310 in patients with seasonal allergic rhinitis, and observing the quality of life, PK, PD characteristics, and immunogenicity of subjects.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment.

  The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.

  Up to week 4

Secondary Outcomes (22)

• Mean change from baseline in daily rTNSS over 4 weeks of treatment

  Up to week 4

• Mean change from baseline in the daily AM and PM reflective total nasal symptom score (AM and PM rTNSS) over 2 and 4 weeks of treatment

  Up to week 4

• Mean change and mean percent change from baseline in daily AM pre-dose instantaneous total nasal symptom score (iTNSS) over 2 weeks and 4 weeks of treatment

  Up to week 4

• Mean percent change from baseline in daily rTNSS over 2 and 4 weeks of treatment

  Up to week 4

• Mean change from baseline in daily rTNSS (including AM rTNSS and PM rTNSS) for individual nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) over 2 and 4 weeks of treatment

  Up to week 4

Study Arms (2)

CM310 group

EXPERIMENTAL

Subcutaneous injection， CM310 4ml for first dose and 2ml for following dose

Biological: CM310

Placebo

PLACEBO COMPARATOR

Subcutaneous injection，matching placebo

Biological: Placebo

Interventions

CM310 BIOLOGICAL

IL-4Rα monoclonal antibody

CM310 group

Placebo BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Able to understand the study and voluntarily sign the ICF;
• Males or females, ≥ 18 and ≤ 65 years old;
• Diagnosed SAR according to the Criteria stated in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition), with or without allergic conjunctivitis, and have SAR history in the same pollen season for at least two years;
• Have immunoglobulin E (IgE)-mediated hypersensitivity to at least one pollen allergen in the current environment, as confirmed by the result of the specific IgE test during the screening/run-in period;
• Adequate pollen exposure during the pollen season: Participants are expected to be in the pollen season for the entire study period and have no travel plans to leave the geographic region more than 48 hours. Definition of a pollen season: the beginning of a pollen season is defined as local pollen count of more than 20/1000 mm2 for three consecutive days, and the end of a pollen season is defined as local pollen count of less than 20/1000 mm2 for three consecutive days.
• Prior to screening, the SAR symptoms of participants remained inadequately controlled (at least one moderate or above SAR symptom) after nasal spray corticosteroids or other SAR medications (antihistamines, leukotriene receptor antagonists, etc.) treatment throughout the same pollen season previously;
• The AM iTNSS ≥ 6 points prior to screening; at the baseline visit, the AM iTNSS ≥ 6 points and the average of the last 6 rTNSS scores ≥ 6 points (i.e., 3 AM and 3 PM assessments over the last three 24-hour periods, including the AM assessment at the baseline visit), with nasal congestion ≥ 2 points and one of the three symptoms of rhinorrhea, nasal itching, and sneezing ≥ 2 points;
• Peripheral blood eosinophils count ≥ 0.3×109/L during the screening/run-in period and baseline visit;
• During the screening/run-in period, participants must complete at least 80% of the assessments in the diary card;
• The participants agree to use highly effective contraception methods from signing of the ICF to 3 months after the last dose of the investigational product.

You may not qualify if:

• Use of anti-interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody, thymic stromal lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonal antibody, other monoclonal antibodies, or other biologics within 10 weeks or 5 half-lives (whichever is longer) prior to the screening visit;
• Use of any investigational product within 4 weeks prior to the screening visit or planning to participate in other clinical studies during this study;
• Use of systemic immunosuppressants (including but not limited to methotrexate, cyclosporine, mycophenolate mofetil, tacrolimus, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, cyclophosphamide) for the treatment of inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) within 8 weeks or 5 half-lives (whichever is longer) prior to the screening visit;
• Infections requiring treatment with systemic antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications within 7 days prior to the screening visit;
• Received short-medium-acting systemic corticosteroids (SCS, including oral, intravenous, or intramuscular glucocorticoids), systemic traditional Chinese medicine preparations for the treatment of allergic rhinitis within 4 weeks prior to screening, or long-acting SCS (such as triamcinolone acetonide injection) within 6 weeks prior to screening, or planning to receive the above drugs during the study;
• Use of monoamine oxidase inhibitors within 14 days prior to the screening visit;
• Participants who initiate immunotherapy within 4 weeks prior to the screening visit, or who plan to initiate immunotherapy during the study; Participants who have been receiving immunotherapy at a stable dose within 4 weeks prior to the screening visit and are able to remain this fixed dose throughout the study can be enrolled;
• Participants with concomitant asthma who start treatment with inhaled corticosteroids within 4 weeks prior to screening: Participants who have been treated with a stable dose of inhaled glucocorticoids (≤ 1000 μg/day of fluticasone propionate or equivalent dose of other inhaled glucocorticoids) for at least 4 weeks prior to screening and the dose remains unchanged throughout the study, is in a stable condition at the investigator's discretion, can be enrolled;
• Forced expiratory volume in 1 second (FEV1) ≤ 50% of the predicted value during the screening/run-in period;
• Have active rhinitis of other type except for SAR, such as acute or chronic rhinitis and non-allergic rhinitis;
• Participants with perennial allergic rhinitis (PAR) who are allergic to pet hair. Participants can be enrolled if they stop exposing to pet hair or are allergic to other indoor allergens;
• Patients with active nasal diseases other than SAR, such as acute or chronic rhinosinusitis or nasal septal deviation, which may affect the efficacy evaluation of the investigational product at the investigator's discretion;
• History of any nasal or sinusoidal surgery within 1 year prior to screening;
• Have acute sinusitis, nasal infection, or upper respiratory tract infection at screening or within 2 weeks prior to screening;
• Have benign or malignant tumors in the nasal cavity;

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Beijing Tong-Ren hospital

Beijing, China

Location

Related Publications (3)

• Zhang Y, Li J, Wang M, Li X, Yan B, Liu J, Shi L, Cao Z, Feng Y, Liu W, Xu Z, Ma R, Gao X, Liu W, Xue J, Ren X, Li X, Song X, Yang Y, Wang Y, Xing Z, Quan F, Pan J, Sun Y, Shi F, Chen X, Yan H, Zhao G, Chen B, Wang C, Zhang L. Stapokibart for moderate-to-severe seasonal allergic rhinitis: a randomized phase 3 trial. Nat Med. 2025 Jul;31(7):2213-2221. doi: 10.1038/s41591-025-03651-5. Epub 2025 Apr 4.

  PMID: 40186079 DERIVED

• Wang M, Zhang Y, Li J, Wang C, Zhang L. Stapokibart (CM310) in patients with uncontrolled seasonal allergic rhinitis (PHECDA): Rationale and design of a multicentre, randomized, double-blind, placebo-controlled study. Asia Pac Allergy. 2025 Mar;15(1):15-20. doi: 10.5415/apallergy.0000000000000174. Epub 2025 Jan 13.

  PMID: 40051426 DERIVED

• Zhang Y, Yan B, Zhu Z, Wang X, Song X, Zhu D, Ma T, Zhang Y, Meng C, Wang G, Wang C, Zhang L. Efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial. EClinicalMedicine. 2024 Feb 6;69:102467. doi: 10.1016/j.eclinm.2024.102467. eCollection 2024 Mar.

  PMID: 38356731 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Luo Zhang

  Beijing Tong-Ren hospital

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 18, 2023
• Study Start: August 10, 2023
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: November 8, 2024

Record last verified: 2023-05

Locations

CN (1)