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New treatment option for Seasonal Allergic Rhinitis
Official title Phase II/III Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic Rhinitis
ClinicalTrials.gov ID: NCT06846385
What this study is testing
What is MG-K10 Humanized Monoclonal Antibody Injection?
MG-K10 Humanized Monoclonal Antibody Injection is an investigational medicine, given as a monthly injectable medicine, being studied as a potential treatment for seasonal allergic rhinitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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) "people conforms to the diagnosis of seasonal allergic...
- During the previous pollen season, the people used nasal corticosteroids or other SAR drugs (antihistamines, leukotriene receptor antagonists, etc.)...
- 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;
You likely can't join 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...
- people 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...
- Use of antihistamines within 4 days prior to randomization;
- Leukotriene receptor antagonists and hypertrophic cell membrane stabilizers were used within 1 week before randomization;
See the full eligibility criteria
Who can join
- 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) "people conforms to the diagnosis of seasonal allergic rhinitis, history 2 years or more clear, at the same time, at least...
- During the previous pollen season, the people 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 people and their partners agreed to use highly effective birth control, and male people and their...
- Be able to understand and comply with clinical protocol requirements, voluntarily participate in clinical trials, and people voluntarily sign written informed consent.
What rules you out
- 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 how well it works evaluator;
- people 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...
- 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...
- 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
- assigned by chance 8 weeks or 5 Systemic immunosuppressants (including but not limited to methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, sulfasulazopyridine, hydroxychloroquine, azathioprine...
- 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...
- Participated in MG-K10 clinical trials;
- Live/attenuated vaccine received within 3 months prior to randomization or during the planned study period; people who started Immunotherapy [including Intravenous Immunoglobin (IVIG) therapy or Specific Immunotherapy...
- Had received any nasal or sinus surgery within 1 year prior to randomization;
- History of vital organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation
- Other nasal comorbiditis or co-occurring diseases/conditions (such as acute/chronic sinusitis, nasal polyps, deviation of nasal septum, drug-induced rhinitis, cerebrospinal fluid rhinorrhea, nasal postoperative status...
- Acute sinusitis, nasal infection, or upper respiratory tract infection during the screening/induction period or within 2 weeks prior to screening;
- Have malignant or benign tumors in the nasal cavity;
- Screening for infections requiring treatment with systemic antimicrobials, antivirals, antifungals, antiparasites or antigenics within 7 days prior to the visit;
- Patients with Perennial Allergic Rhinitis (PAR) who are allergic to pet hair (if the subject is currently free of pet hair contact) may be included. PAR people who are allergic to other indoor allergens may be included);
- Have a history of lymphoproliferative diseases, or have had or are present with malignant tumors within 5 years prior to screening (except for skin squamous cell carcinoma in situ, basal cell carcinoma, and cervical...
- Have a history or evidence of high risk cardiovascular disease
- Have posterior subcapsular cataracts or glaucoma, or any other eye condition that may affect the evaluation of eye symptoms, or related conditions listed below
- Active TB infection is present or suspected;
- Presence or suspected worm infection within 6 months;
- A history of severe herpes virus infection, such as herpes encephalitis, disseminated herpes, etc.
- Patients with severe diseases of the central nervous system, respiratory system, liver, kidney, gastrointestinal, urinary, endocrine, or blood systems that the investigator believes may affect the how well it works and...
- Known or suspected immunosuppressed individuals, including, but not limited to, a history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidosis, pulmonary cyst disease...
- The presence of any significant laboratory anomalies
- Pregnant or lactating women, or those with a positive pre-assigned by chance serum pregnancy test
- According to the judgment of the researcher, it is not suitable to participate in this researcher for other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.