Phase II/III Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic Rhinitis

NCT06846385 | Recruiting Phase 2

• 1 other identifier: MG-K10-SAR-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, randomized, double-blind, placebo-controlled Phase II/III seamless clinical study evaluating the efficacy, safety, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, and immunogenicity of MG-K10 humanized monoclonal antibody injection in the treatment of seasonal allergic rhinitis

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Change in mean rTNSS from baseline after 2 weeks of treatment

  2 weeks

Secondary Outcomes (3)

• Rate of change of mean rTNSS from baseline after 2 weeks of treatment

  2 weeks

• Rate of change of mean rTNSS from baseline after 4 weeks of treatment

  4 weeks

• Change in mean instantaneous total nasal symptom score from baseline after 2 and 4 weeks of treatment

  2 and 4 weeks

Study Arms (2)

MG-K10 Humanized Monoclonal Antibody Injection

EXPERIMENTAL

A single dose was administered

Biological: MG-K10 Humanized Monoclonal Antibody Injection

placebo

PLACEBO COMPARATOR

A single dose was administered

Biological: Placebo

Interventions

Placebo BIOLOGICAL

A single dose was administered

placebo

MG-K10 Humanized Monoclonal Antibody Injection BIOLOGICAL

MG-K10 Humanized Monoclonal Antibody Injection

MG-K10 Humanized Monoclonal Antibody Injection

Eligibility Criteria

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

You may qualify if:

• Age of 18-75 years old (including the cutoff value), male or female;
• With reference to the diagnosis and treatment of allergic rhinitis China guide (2022 revision) "subjects conforms to the diagnosis of seasonal allergic rhinitis, history 2 years or more clear, at the same time, at least one over the same period of the current season or allergic rhinitis disease related Skin prick test (Skin Prick Test, SPT) or serum Specific IgE (sIgE) (acceptable within less than 1 year before randomization), and the results met the diagnostic criteria for SAR
• During the previous pollen season, the subjects used nasal corticosteroids or other SAR drugs (antihistamines, leukotriene receptor antagonists, etc.), and their SAR symptoms were poorly controlled.
• The following criteria were met at screening and baseline:
• iTNSS score at screening ≥6, nasal congestion ≥2, runny nose, nasal itching, and sneezing 3. One of the symptoms ≥2 points;
• iTNSS score ≥6 at baseline; rTNSS≥6 points, nasal congestion ≥2 points, runny nose, nose,one of the three symptoms of itching and sneezing ≥2 points
• Throughout the study period (from signing the ICF to 6 months after the study drug administration), fertile female subjects and their partners agreed to use highly effective birth control, and male subjects and their partners agreed to use effective birth control and had no plans to donate sperm (men) or eggs (women)
• Be able to understand and comply with clinical protocol requirements, voluntarily participate in clinical trials, and subjects voluntarily sign written informed consent.

You may not qualify if:

• Allergy to the study drug or its excipients;
• Travel plans for 48 hours or more from known pollen areas during the screening/induction and treatment periods (visit 5);
• The subject's exposure to allergens in his or her home or work environment may have changed significantly during the trial, which the investigator determines may affect the efficacy evaluator;
• Subjects with limited outdoor activities during the day were defined as those who did not have any outdoor activities during the day for 1 or 4 days per week.
• ·Patients who have previously received anti-interleukin-4 receptor alpha (IL-4Rα) monoclonal antibody drugs (such as dupriuzumab) for Allergic Rhinitis (AR) have poor response (such as treatment failure or treatment intolerance);
• Use of antihistamines within 4 days prior to randomization;
• Leukotriene receptor antagonists and hypertrophic cell membrane stabilizers were used within 1 week before randomization;
• Received medium - and short-acting Systemic Crticosteroids (SCS, including oral, intravenous and intramuscular glucocorticoids) and Chinese medicine for AR treatment (systemic Chinese medicine preparation) within 4 weeks before randomization. Had received long-acting SCS (such as triamcinolone olone injection) within 6 weeks prior to randomization, or planned to receive these medications during the study period;
• Participants with asthma who began inhaled glucocorticoid therapy within the first 4 weeks of randomization.
• Stable dose inhaled glucocorticoids were used for at least 4 weeks and evaluated before randomization
• The dose of inhaled glucocorticoids was maintained during the study period, while the dosage of inhaled glucocorticoids was ≤1000 μg/ day of fluticasone propionate or equivalent doses of other inhaled glucocorticoids
• Randomized 8 weeks or 5 Systemic immunosuppressants (including but not limited to methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, sulfasulazopyridine, hydroxychloroquine, azathioprine, cyclophosphamide) have been used within a half-life (whichever is longer) to treat inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic disease) Lupus erythematosus, multiple sclerosis, etc);
• random or 10 weeks before 5 within the half-life of longer (in time) received anti IL - 4 r alpha monoclonal antibody, Thymic Stromal lymphocytes (Thymic Stromal Lymphopoietin, TSLP) monoclonal antibody, anti-IGE monoclonal antibody, other monoclonal antibody or other biologic agent therapy;
• Participated in MG-K10 clinical trials;
• Live/attenuated vaccine received within 3 months prior to randomization or during the planned study period; Subjects who started Immunotherapy \[including Intravenous Immunoglobin (IVIG) therapy or Specific Immunotherapy (SIT) therapy\] within 6 months before randomization, Participants who plan to begin immunotherapy during the study;

Sponsors & Collaborators

• Shanghai Mabgeek Biotech.Co.Ltd: lead

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100009, China

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

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

Central Study Contacts

lipeng liu, bachelor

CONTACT

02151371305; lipeng.liu@mabgeek.com

chao deng, bachelor

CONTACT

+86 15712950928; chao.deng@mabgeek.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 26, 2025
• Study Start: March 20, 2025
• Primary Completion: May 31, 2025
• Study Completion: September 30, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)