Allergic RhinitisPhase 3PHECDANCT05908032

Study of CM310 in Subjects With Allergic Rhinitis

A Phase 3 study testing CM310 in people with Allergic Rhinitis, run by Keymed Biosciences Co.Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Allergic Rhinitis
What is being tested?: CM310
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 108 participants
Where: 1 siteChina
Study dates: 10 Aug 2023to 4 Dec 2023
Phase: Phase 3
Are there results?: None posted in the registry

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Show all 10Show fewer

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.

Who cannot join

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;

Show all 25Show fewer

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;
Previously received an anti-IL-4Rα monoclonal antibody (e.g., dupilumab) for the treatment of AR with poor response (e.g., treatment failure or intolerance);
Participants who are allergic to MFNS, loratadine, any anti-IL-4Rα monoclonal antibody or any component of CM310;
Comorbidity of other poorly controlled serious diseases or chronic diseases, including but not limited to active infection, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes, autoimmune diseases, human immunodeficiency virus infection, treponema pallidum infection, active hepatitis B, hepatitis C or parasitic diseases;
Participants with malignancy within 5 years prior to screening (except for completely cured cervical carcinoma in situ and non-metastatic squamous cell or basal cell carcinoma of the skin);
Participants with severe hepatic or renal impairment, such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN), total bilirubin > 1.5 times the ULN, or serum creatinine > 1.2 times the ULN;
Have received a live-attenuated vaccine within 12 weeks prior to randomization or planning to receive one during the study;
Known or suspected immunosuppression, including but not limited to a history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even after this infection condition has recovered; or with unusually frequent, recurrent, or long-term infections at the investigator's discretion;
Pregnant or breast-feeding women, or women who plan to become pregnant or breast-feeding during the study;
Heavy alcohol consumption [i.e., more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of distilled spirits with 40% alcohol or 150 mL of wine)] or history of drug abuse within 3 months prior to screening;
Participants with any other conditions that are considered by the investigator as unsuitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Tong-Ren hospital
Beijing

Other trials in China

About this study

Official title: 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

Read the 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.

Conditions: Allergic Rhinitis
Being tested: CM310, Placebo
Medical subject headings: Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CM310Biological
IL-4Rα monoclonal antibody
PlaceboBiological
Placebo

Study groups in NCT05908032
Study group	Role	What they receive
CM310 group	Experimental	Subcutaneous injection， CM310 4ml for first dose and 2ml for following dose Receives: Biological: CM310
Placebo	Placebo comparator	Subcutaneous injection，matching placebo Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to week 4

Secondary outcomes (22)

Mean change from baseline in daily rTNSS over 4 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.
Measured: 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
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.
Measured: 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
The instantaneous total symptom scores (iTNSS) are the rating of the severity of instantaneous symptoms at a time point.
Measured: Up to week 4
Mean percent change from baseline in daily rTNSS over 2 and 4 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.
Measured: 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
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.
Measured: 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
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.
Measured: 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
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.
Measured: Up to week 4
Mean change from baseline in daily AM pre-dose instantaneous total ocular symptom score (iTOSS) over 2 weeks and 4 weeks of treatment
The instantaneous total symptom scores (iTOSS) are the rating of the severity of instantaneous symptoms at a time point.
Measured: Up to week 4
Mean percent change from baseline in daily rTOSS over 2 weeks and 4 weeks of treatment
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.
Measured: Up to week 4
Mean percent change from baseline in daily AM pre-dose iTOSS over 2 weeks and 4 weeks of treatment
The instantaneous total symptom scores (iTOSS) are the rating of the severity of instantaneous symptoms at a time point.
Measured: 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
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.
Measured: 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
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a 28-item, self-administered, disease-specific (AR) quality of life scale used by participants to assess quality of life over a week.
Measured: Up to week 4
Time to onset of treatment effect
The reflective scores (rTNSS, rTOSS) represent the participant's symptoms in the previous 12 hours. The instantaneous total symptom scores (iTNSS, iTOSS) are the rating of the severity of instantaneous symptoms at a time point.
Measured: Up to week 4
Time to maximum treatment effect
The reflective scores (rTNSS, rTOSS) represent the participant's symptoms in the previous 12 hours. The instantaneous total symptom scores (iTNSS, iTOSS) are the rating of the severity of instantaneous symptoms at a time point.
Measured: 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
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.
Measured: Up to week 4
Number of days with no or mild symptoms over 2 weeks and 4 weeks of treatment
Based on all the endpoints of TNSS and TOSS.
Measured: Up to week 4
Incidence of adverse events (AEs)
Evaluate the incidence of treatment-emergency adverse events.
Measured: Up to wee 12
Serum CM310 concentration
Collect the blood samples for Pharmacokinetics analysis
Measured: Up to week 12
Change and percent change from baseline of human thymus and activation-regulated chemokine (TARC)
Collect the blood samples for Pharmacodynamics analysis
Measured: Up to week 12
change and percent change from baseline of total immunoglobulin E (IgE) in serum/plasma
Collect the blood samples for Pharmacodynamics analysis
Measured: Up to week 12
change and percent change from baseline of counts and ratios of eosinophil in blood
Collect the blood samples for Pharmacodynamics analysis
Measured: Up to week 12
The development of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Collect the blood samples for anti-drug antibody testing
Measured: Up to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 20234 Dec 2023

First posted18 Jun 2023
Study start10 Aug 2023
Primary completion4 Dec 2023
Study completion4 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Allergic RhinitisStudies of the same condition, open and under way.
More trials run by Keymed Biosciences 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05908032
Sponsor's protocol ID: CM310-107206
Acronym: PHECDA
Status last verified: May 2023
First submitted: 2 Jun 2023
Last updated: 8 Nov 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 40186079
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.
PubMed 40051426
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.
PubMed 38356731

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom

All Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05908032
Acronym / sponsor ID: PHECDA / CM310-107206
Conditions: Allergic Rhinitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
Study start: 10 Aug 2023 (actual)
Primary completion: 4 Dec 2023 (actual)
Study completion: 4 Dec 2023 (actual)
First posted: 18 Jun 2023 (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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CM310 group	Experimental	Biological: CM310Subcutaneous injection， CM310 4ml for first dose and 2ml for following dose
Placebo	Placebo comparator	Biological: PlaceboSubcutaneous injection，matching placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (25 listed)

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;

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
CM310IL-4Rα monoclonal antibody	Biological	CM310 group
PlaceboPlacebo	Biological	Placebo

Primary outcome

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.

22 secondary outcomes

Mean change from baseline in daily rTNSS over 4 weeks of treatment
Time frame: 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
Time frame: 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
Time frame: Up to week 4
Mean percent change from baseline in daily rTNSS over 2 and 4 weeks of treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to week 4
Mean change from baseline in daily AM pre-dose instantaneous total ocular symptom score (iTOSS) over 2 weeks and 4 weeks of treatment
Time frame: Up to week 4
Mean percent change from baseline in daily rTOSS over 2 weeks and 4 weeks of treatment
Time frame: Up to week 4
Mean percent change from baseline in daily AM pre-dose iTOSS over 2 weeks and 4 weeks of treatment
Time frame: 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
Time frame: 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
Time frame: Up to week 4
Time to onset of treatment effect
Time frame: Up to week 4
Time to maximum treatment effect
Time frame: 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
Time frame: Up to week 4
Number of days with no or mild symptoms over 2 weeks and 4 weeks of treatment
Time frame: Up to week 4
Incidence of adverse events (AEs)
Time frame: Up to wee 12
Serum CM310 concentration
Time frame: Up to week 12
Change and percent change from baseline of human thymus and activation-regulated chemokine (TARC)
Time frame: Up to week 12
change and percent change from baseline of total immunoglobulin E (IgE) in serum/plasma
Time frame: Up to week 12
change and percent change from baseline of counts and ratios of eosinophil in blood
Time frame: Up to week 12
The development of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time frame: Up to week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
Derived from this study: PubMed 40186079Zhang 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.
Derived from this study: PubMed 40051426Wang 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.
Derived from this study: PubMed 38356731Zhang 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.

Related trials for Allergic Rhinitis

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom

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. This study is not recruiting at the moment.

Luo Zhang principal investigator

Beijing Tong-Ren hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CM310 in people with Allergic Rhinitis, run by Keymed Biosciences 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 10 inclusion and 25 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: finished, as of the sponsor's last update on 8 Nov 2024. 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment. (time frame: Up to week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05908032, which also lists 3 linked publications.

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 8 Nov 2024.