Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-01 @ 1:33 PM
Study NCT ID:
NCT05816395
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2023-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of RHH646 for Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic 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': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-03-31', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in cartilage volume in the index region of the target knee by magnetic resonance imaging at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'Change in cartilage volume in certain regions in the knee measured by magnetic resonance imaging at Week 52 compared to the volume prior to receiving RHH646'}, {'measure': 'Number of participants with Adverse Events', 'timeFrame': 'From start of treatment until study completion (approximately 14 months)', 'description': 'Adverse events and clinically notable findings in vital signs, ECG, hematology, blood chemistry, and urinalysis'}], 'secondaryOutcomes': [{'measure': 'RHH646 plasma concentrations', 'timeFrame': 'Baseline, up to End of Study visit (approximately month 13)', 'description': 'Concentration of RHH646 in plasma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tibiofemoral OA', 'K&L grade 2 to 3 OA in the target knee', 'Oral RHH646 treatment'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the articular cartilage-regenerating capacity of RHH646 in the knee as well as to assess safety and tolerability in participants with knee osteoarthritis. The treatment duration will be up to 52 weeks. The total study duration for an individual participant will be up to 62 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is ≥35 and ≤75 years old, at time of screening\n* Participants must weigh at least 50 kg to participate in the study and must have a body mass index (BMI) ≤35 kg/m2. BMI = Body weight (kg) / \\[Height (m)\\]2\n* Diagnosis of tibiofemoral OA in at least one knee by standard American College of Rheumatology clinical and radiographic criteria (Altman et al 1986) at screening\n* K\\&L grade 2 to 3 OA in the target knee evaluated with X-Ray by the Central Reader at screening\n* Predominantly medial tibiofemoral compartment involvement defined as medial Joint Space Narrowing (medJSN) 1-2 (Altman et al 1995; Altman, Gold 2007) and medJSN \\> lateral Joint Space Narrowing (latJSN) in the target knee evaluated with X-Ray by the Central Reader at screening\n* Symptomatic disease, defined as having pain in the target knee at least 3 days per week during the last 3 months from screening that is relieved by analgesic therapy (e.g. acetaminophen or non-steroidal anti-inflammatory drugs), according to the investigator's evaluation and judgment of the patient's history\n\nExclusion Criteria:\n\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception. In EEA countries, women of child-bearing potential will be excluded from participation in this trial, irrespective of the use of highly effective methods of contraception.\n* Arthroscopy of the target knee within the 6 months prior to screening or planned arthroscopy during the study\n* Previous surgical treatment of the target knee using mosaicplasty, microfracture, meniscectomy \\>50% or osteotomy; planned surgery for either knee during the study\n* Unstable target knee joint (including, but not limited to, post-traumatic or congenital laxity) or insufficiently reconstructed ligaments based on medical history and/or physical examination by the investigator\n* Participant has severe malalignment (valgus or varus deformity) in the target knee \\>7.5° based on X-ray evaluation by the Central Reader at screening.\n* K\\&L grade 4 OA in either knee\n* Presence of severe hip OA that either (i) alters lower limb function to a degree that increases or abnormally changes the mechanical forces in the knee while walking, according to investigator's evaluation or (ii) currently requires or is likely to require specific medical or surgical management during the study period\n* Other pathologies affecting the knee, including subchondral insufficiency fractures, bone fracture (acute or subacute within the 6 months prior to screening) or bone bruise, osteonecrosis, malignant bone marrow infiltration, solid tumors, and/or patellofemoral dysplasia based on clinical assessment, or imaging\n* Known autoimmune disease with inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus), crystal-induced arthritides (gout or pseudogout arthritis), active acute or chronic infection of the knee joint, Lyme disease involving the knee, reactive arthritis, systemic cartilage disorders, moderate to severe fibromyalgia, a known systemic connective tissue disease or a widespread pain index \\>4.\n* Inability to undergo MRI (e.g., claustrophobia, body size, leg not fitting in the coil) or contraindications to MRI (e.g., non MRI-compatible metallic implants, metallic foreign bodies, pacemaker, defibrillator)"}, 'identificationModule': {'nctId': 'NCT05816395', 'briefTitle': 'Safety and Efficacy of RHH646 for Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Placebo Controlled, Investigator and Participant-blinded Study Investigating Safety, Tolerability, and Efficacy of RHH646 in Participants With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'CRHH646A12201'}, 'secondaryIdInfos': [{'id': '2022-502821-16-00', 'type': 'OTHER', 'domain': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RHH646', 'description': 'RHH646', 'interventionNames': ['Drug: RHH646']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'RHH646 placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RHH646', 'type': 'DRUG', 'description': 'RHH646 capsule for oral use', 'armGroupLabels': ['RHH646']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'RHH646 placebo capsule for oral use', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Research', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Conquest Research', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trial Network', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Pioneer Research Solutions', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': 'C1015ABO', 'city': 'Ciudad Autonoma de Bs As', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': 'C1055AAF', 'city': 'Ciudad Autonoma de Bs As', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': '9362', 'city': 'Gandrup', 'country': 'Denmark', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 57.05744, 'lon': 10.18137}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '00-874', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '15705', 'city': 'Santiago de Compostela', 'state': 'A Coruna', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}