Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT06496620
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2024-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': 171}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in blood eosinophil counts', 'timeFrame': 'Through week 12', 'description': 'To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'Through week 12 To week 28', 'description': 'To assess the safety and tolerability of multiple doses of solrikitug'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (COPD).', 'detailedDescription': 'This is a 12-week randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 2 dose levels of solrikitug versus placebo on top of standard of care in participants with COPD.\n\nApproximately 171 eligible participants with COPD will be randomized at approximately 60-90 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 12-week treatment period. The study also includes a post-treatment follow-up period of 16 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 40 years of age and no older than 75 years.\n* Documented diagnosis of COPD for at least 12 months prior to Screening, defined by the GOLD Guidelines (2023), and elevated blood eosinophils at screening.\n* At Screening FEV1/FVC ratio must be \\<0.70, and Post-bronchodilator FEV1 must be ≥40% to \\<80% predicted normal value calculated using Global Lung Function Initiative (GLI) reference equations (Cooper et al 2017).\n* Symptomatic (COPD Assessment Test \\[CAT\\] Score ≥10) at Screening Visit 1.\n* Participants must be on 2 or more inhaled maintenance medications for management of their COPD, for at least 3 months prior to screening.\n\nExclusion Criteria:\n\n* Female participant who is pregnant or breastfeeding.\n* Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody.\n* Participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the Investigator or Medical Monitor might obfuscate the study data.\n* Any other pulmonary disease than COPD that in the opinion of the Investigator, the severity of the disorder would impact the conduct of the study.\n* Undergone major lung surgery, within 1 year of Screening Visit 1.\n* Participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to Screening.'}, 'identificationModule': {'nctId': 'NCT06496620', 'acronym': 'ZION', 'briefTitle': 'A Study to Evaluate Solrikitug in Participants With COPD (ZION)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Uniquity One (UNI)'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants With Chronic Obstructive Pulmonary Disease (ZION)', 'orgStudyIdInfo': {'id': 'NSI-8226-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biological: Solrikitug High Dose', 'description': 'Solrikitug', 'interventionNames': ['Biological: Biological: Solrikitug high dose']}, {'type': 'OTHER', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Biological: Solrikitug Low Dose', 'description': 'Solrikitug', 'interventionNames': ['Biological: Biological: Solrikitug low dose']}], 'interventions': [{'name': 'Biological: Solrikitug low dose', 'type': 'BIOLOGICAL', 'description': 'Solrikitug subcutaneous injection', 'armGroupLabels': ['Biological: Solrikitug Low Dose']}, {'name': 'Biological: Solrikitug high dose', 'type': 'BIOLOGICAL', 'description': 'Solrikitug subcutaneous injection', 'armGroupLabels': ['Biological: Solrikitug High Dose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Site', 'role': 'CONTACT'}], 'facility': 'Research Site 034', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Site', 'role': 'CONTACT'}], 'facility': 'Research Site 099', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85351', 'city': 'Sun City', 'state': 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