Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-29 @ 7:45 AM
Study NCT ID:
NCT06300203
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2024-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-20', 'studyFirstSubmitDate': '2024-03-02', 'studyFirstSubmitQcDate': '2024-03-02', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average change from baseline in daily retrospective total nasal symptom score (rTNSS) at week 2.', 'timeFrame': 'up to Week 2', 'description': 'Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period. The Total Nasal Symptom Score (TNSS) is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Seasonal Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.', 'detailedDescription': "AR is a common clinical chronic nasal disease, affecting 10% to 20% of the world's population, and has become a global health problem. AR not only seriously affects the quality of life of patients, resulting in patient fatigue, impaired learning, attention, and decision-making ability, but also causes a heavy social burden.\n\nAR has a variety of classification methods. According to the type of allergen, it can be divided into seasonal (SAR, common allergens are seasonal allergens such as pollen) and perennial (PAR, common allergens are indoor allergens such as dust mites or occupational allergies), which is a classification method often used in clinical studies. According to the course of the disease, it can be divided into intermittent (symptom onset \\< 4 days/week, or \\< 4 consecutive weeks) and persistent (symptom onset ≥ 4 days/week, and ≥ 4 consecutive weeks). According to the severity of the disease, it can be divided into minor AR (mild symptoms, with no significant impact on quality of life) and moderate-severe AR (more severe or severe symptoms, with significant impact on quality of life). The results of the cooperative survey showed that persistent moderate-to-severe disease was the most common in the overall population, accounting for 52.2%, indicating that the treatment and control of AR has become an urgent problem to be solved."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Have any condition that are not suitable for participating in this study.'}, 'identificationModule': {'nctId': 'NCT06300203', 'acronym': 'MEGREZ', 'briefTitle': 'Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'officialTitle': 'The Efficacy and Safety of Humanized Antibody Targeting the Interleukin-4 Receptor Alpha Subunit (IL-4Rα) in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Standard Treatment： A Randomized, Double-Blind, Placebo-controlled IIT Study', 'orgStudyIdInfo': {'id': 'CM310_IIS_SAR07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interleukin-4 receptor responders', 'description': 'Interleukin-4 receptor was injected subcutaneously.', 'interventionNames': ['Biological: Interleukin-4 receptor responders']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo was injected subcutaneously.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Interleukin-4 receptor responders', 'type': 'BIOLOGICAL', 'description': 'Interleukin-4 receptor was injected subcutaneously.', 'armGroupLabels': ['Interleukin-4 receptor responders']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo was injected subcutaneously.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Luo Zhang', 'role': 'CONTACT', 'email': 'dr.luozhang@139.com', 'phone': '+86-13910830399'}], 'facility': 'Beijing Tongren Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Luo Zhang', 'role': 'CONTACT', 'email': 'dr.luozhang@139.com', 'phone': '+86-13910830399'}], 'overallOfficials': [{'name': 'Luo Zhang', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Tong-Ren hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}