Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-05 @ 8:12 PM
Study NCT ID:
NCT07226258
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-06', 'studyFirstSubmitQcDate': '2025-11-06', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in the Weekly Mean of the Average Daily Pain Intensity While Walking', 'timeFrame': 'Baseline to week 12', 'description': 'The pain intensity score is measured using a numeric rating scale (NRS)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis Knee Pain']}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 for the Treatment of Knee Pain in Patients with Osteoarthritis of the Knee.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single treatment of SL1002 compared to placebo for the treatment of knee pain associated with mild to moderate osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria includes:\n\n1. Male or female patients ≥ 40 years of age\n2. Body Mass Index (BMI) limits\n3. Chronic knee pain resulting from osteoarthritis\n4. Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate)\n5. Baseline KOOS pain\n6. Patients taking baseline analgesics\n7. Diagnostic nerve block response\n8. Compliance with identified study requirements\n\nExclusion Criteria includes:\n\n1. Non-OA inflammatory arthritis\n2. Confounding elements\n3. Lower limb amputation.\n4. Specified alternate historic treatments\n5. Identified underlying physiologic or psychosocial conditions\n6. Patient Health Questionnaire\n7. Moderate to severe hepatic impairment\n8. Moderate to severe renal impairment\n9. Identifiable baseline medications\n10. Protocol compliance requirements\n11. Known allergies or hypersensitivity to identified agents\n12. Identified alcohol or drug abuse history\n13. Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment\n14. Identified underlying abnormal laboratory results'}, 'identificationModule': {'nctId': 'NCT07226258', 'briefTitle': 'Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Saol Therapeutics Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 Injectable for the Treatment of Knee Pain in Patients With Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'SL-1010-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SL1002', 'description': 'SL1002', 'interventionNames': ['Drug: SL1002']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal saline', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'SL1002', 'type': 'DRUG', 'description': 'SL1002 injectable solution', 'armGroupLabels': ['SL1002']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Normal Saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott Bainbridge, MD', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-0827'}, {'name': 'Scott Bainbridge, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'DBPS Research, LLC', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '20006', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mehul Desai, MD', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '7702740827'}], 'facility': 'International Spine, Pain & Performance Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Miguel Telleria, M.D.', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-0827'}, {'name': 'Miguel Telleria, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prime Medical Research', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32832', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jorge Fernandez-Silva, M.D.', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-0827'}, {'name': 'Jorge Fernandez-Silva, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Conquest Research, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anand Patel, M.D.', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-0827'}, {'name': 'Anand Patel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Conquest Research, LLC', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Gilmore, M.D.', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-0827'}, {'name': 'Christopher Gilmore, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen City Clinical Research, PLLC', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leonardo Kapural, MD', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-0827'}, {'name': 'Leonardo Kapural, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Center for Clinical Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '97404', 'city': 'Eugene', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gregory Moore, M.D.', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-0827'}, {'name': 'Gregory Moore, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pacific Sports and Spine', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '16602', 'city': 'Altoona', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Fred Khalouf, D.O.', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-0827'}, {'name': 'Fred Khalouf, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Orthopedics Center', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'zip': '29601', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Jakubowicz, M.D.', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-0827'}, {'name': 'Brian Jakubowicz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PCPMG Clinical Research Unit, LLC', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daneshvari Solanki, MD', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-0827'}, {'name': 'Daneshvari Solanki, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HD Research, First Surgical Hospital (FSH)', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '78414', 'city': 'Corpus Christi', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mitchell Engle, M.D.', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-0827'}, {'name': 'Mitchell Engle, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Precision Pain Medicine', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '23238', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael DePalma, MD', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-0827'}, {'name': 'Michael DePalma, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virginia iSpine Physicians, PC', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'centralContacts': [{'name': 'Kiki Diorgu, M.D.', 'role': 'CONTACT', 'email': 'info@saolrx.com', 'phone': '770-274-2827'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saol Therapeutics Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}