A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of CM310 Under Background Treatment in Patients With Seasonal Allergic Rhinitis Inadequately Controlled With Current Recommended Therapies

Keymed Biosciences Co.Ltd1 site in 1 country108 target enrollmentAugust 10, 2023

ConditionsAllergic Rhinitis

InterventionsCM310 Placebo

DrugsCM310 Placebo

Overview

Phase: Phase 3
Intervention: CM310
Conditions: Allergic Rhinitis
Sponsor: Keymed Biosciences Co.Ltd
Enrollment: 108
Locations: 1
Primary Endpoint: Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Detailed Description

Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens. All participants will receive standard of care treatment as concomitant medications. CM310 or placebo will be administered as add-on therapy.

Registry

clinicaltrials.gov

Start Date

August 10, 2023

End Date

December 4, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Keymed Biosciences Co.Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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;

Arms & Interventions

CM310 group

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

Intervention: CM310

Placebo

Subcutaneous injection，matching placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: Up to week 4

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.

Secondary Outcomes

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 percent change from baseline in daily rTNSS over 2 and 4 weeks of treatment(Up to week 4)
Mean percent change from baseline in daily rTOSS over 2 weeks and 4 weeks of treatment(Up to week 4)
The change from baseline in rhinoconjunctivitis quality of life questionnaire (RQLQ) score in allergic rhinitis participants over 2 weeks and 4 weeks of treatment(Up to week 4)
Mean change from baseline in daily rTNSS over 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 change and mean percent change from baseline in daily reflective total ocular symptom score (rTOSS) over 2 weeks or 4 weeks of treatment(Up to week 4)
Mean change from baseline in daily AM and PM reflective total ocular symptom score (AM and PM rTOSS) over 2 weeks 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)
Mean change from baseline in daily rTOSS (including AM and PM rTOSS) for individual symptoms (itching/burning eyes, tearing/watering eyes, and eye redness) over 2 weeks and 4 weeks of treatment(Up to week 4)
Change and percent change from baseline of human thymus and activation-regulated chemokine (TARC)(Up to week 12)
Serum CM310 concentration(Up to week 12)
Mean change from baseline in daily AM pre-dose instantaneous total ocular symptom score (iTOSS) over 2 weeks and 4 weeks of treatment(Up to week 4)
Number of days with no or mild symptoms over 2 weeks and 4 weeks of treatment(Up to week 4)
The development of anti-drug antibody (ADA) and neutralizing antibody (Nab)(Up to week 12)
Mean percent change from baseline in daily AM pre-dose iTOSS over 2 weeks and 4 weeks of treatment(Up to week 4)
Time to maximum treatment effect(Up to week 4)
Incidence of adverse events (AEs)(Up to wee 12)
change and percent change from baseline of total immunoglobulin E (IgE) in serum/plasma(Up to week 12)
change and percent change from baseline of counts and ratios of eosinophil in blood(Up to week 12)
Time to onset of treatment effect(Up to week 4)
Area under the curve of the change from baseline in the daily rTNSS over 2 weeks and 4 weeks of treatment(Up to week 4)