Seasonal Allergic RhinitisPhase 2/3NCT06846385
Phase II/III Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic Rhinitis
A Phase 2/3 study testing MG-K10 Humanized Monoclonal Antibody Injection in people with Seasonal Allergic Rhinitis, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- MG-K10 Humanized Monoclonal Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2025to 30 Sep 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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) "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.
Who cannot join
- 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;
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- 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;
- 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 within 1 year, etc.) were present at the time of screening and could affect the efficacy evaluation as assessed by the investigators;
- 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 subjects 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 carcinoma in situ after thorough treatment without any signs of recurrence);
- 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 efficacy and safety of the subject;
- 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, aspergillosis), even if the infection has resolved; Or unusual frequent, recurrent, or long-term infections (as determined by the investigator)
- The presence of any significant laboratory anomalies
- Pregnant or lactating women, or those with a positive pre-randomized serum pregnancy test
- According to the judgment of the researcher, it is not suitable to participate in this researcher for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100009
Luo Zhang, Medical Ph.D, +86 13910830399, dr.luozhang@139.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Seamless Clinical Study Evaluating the Efficacy, Safety, PK, PD, and ADA of MG-K10 Humanized Monoclonal Antibody Injection in the Treatment of Seasonal Allergic Rhinitis
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
Read the detailed description
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.
About 120 patients with seasonal allergic rhinitis in stage II and 106 patients with monthly seasonal allergic rhinitis in stage III received only one dose. The study was divided into a screening period (1 week), a double-blind treatment period (4 weeks) and a safety follow-up period (2 weeks).
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Placebo, MG-K10 Humanized Monoclonal Antibody Injection
- Keywords
- Seasonal allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
A single dose was administered
MG-K10 Humanized Monoclonal Antibody InjectionBiological
MG-K10 Humanized Monoclonal Antibody Injection
| Study group | Role | What they receive |
|---|---|---|
| MG-K10 Humanized Monoclonal Antibody Injection | Experimental | A single dose was administered Receives: Biological: MG-K10 Humanized Monoclonal Antibody Injection |
| placebo | Placebo comparator | A single dose was administered Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean rTNSS from baseline after 2 weeks of treatment
Measured: 2 weeks
Secondary outcomes (3)
Rate of change of mean rTNSS from baseline after 2 weeks of treatment
Measured: 2 weeks
Rate of change of mean rTNSS from baseline after 4 weeks of treatment
Measured: 4 weeks
Change in mean instantaneous total nasal symptom score from baseline after 2 and 4 weeks of treatment
Measured: 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start20 Mar 2025
- Primary completion31 May 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Shanghai Mabgeek Biotech.Co.LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846385
- Sponsor's protocol ID
- MG-K10-SAR-001
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Seamless Clinical Study Evaluating the Efficacy, Safety, PK, PD, and ADA of MG-K10 Humanized Monoclonal Antibody Injection in the Treatment of Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT06846385
- Acronym / sponsor ID
- MG-K10-SAR-001
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Seasonal allergic rhinitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
About 120 patients with seasonal allergic rhinitis in stage II and 106 patients with monthly seasonal allergic rhinitis in stage III received only one dose. The study was divided into a screening period (1 week), a double-blind treatment period (4 weeks) and a safety follow-up period (2 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MG-K10 Humanized Monoclonal Antibody Injection | Experimental | Biological: MG-K10 Humanized Monoclonal Antibody InjectionA single dose was administered |
| placebo | Placebo comparator | Biological: PlaceboA single dose was administered |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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)
Key exclusion criteria (33 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboA single dose was administered | Biological | placebo |
| MG-K10 Humanized Monoclonal Antibody InjectionMG-K10 Humanized Monoclonal Antibody Injection | Biological | MG-K10 Humanized Monoclonal Antibody Injection |
Primary outcome
Change in mean rTNSS from baseline after 2 weeks of treatment
Time frame: 2 weeks
3 secondary outcomes
Rate of change of mean rTNSS from baseline after 2 weeks of treatment
Time frame: 2 weeks
Rate of change of mean rTNSS from baseline after 4 weeks of treatment
Time frame: 4 weeks
Change in mean instantaneous total nasal symptom score from baseline after 2 and 4 weeks of treatment
Time frame: 2 and 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MG-K10 Humanized Monoclonal Antibody Injection in people with Seasonal Allergic Rhinitis, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lipeng liu, bachelor (02151371305, lipeng.liu@mabgeek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean rTNSS from baseline after 2 weeks of treatment (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.