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"}}},"trialDetailsJson":{"title":"Details Page","returnSearch":"Back to search results","description":"Study Description","identifier":"ViiV Study ID","clinicalID":"Clinicaltrials.gov Identifier","EudraCtID":"EudraCT Number","resultsAvailable":"Has Results Available Below","docAvailable":"Has Results Document Available","studyOverview":"Study Overview","overviewSection":{"conditionsDisplay":"Medical Conditions","product":"Product","collaborators":"Collaborators","dates":"Date","studyType":"Type","phase":"Phase","gender":"Gender","age":"Age","acceptVolunteers":"Accepts Healthy Volunteers"},"studyDocuments":"Study Documents","noDocuments":"No documents available","studyDocumentsAdditionalText":"If you wish to request for Full Study Report, please contact - ","studyDocumentsAdditionalEmail":"GSKClinicalSupportHD@gsk.com","isReleased":{"firstPart":"This study has Protocol and Result summary on ClinicalTrial.gov. Click","secondPart":"to learn more.","linkText":"here"},"mapLocations":"Locations","centralContact":"Central Contact","centralPhone":"Central Contact Phone","centralEmail":"Central Contact Email","mapSection":{"site":"GSK Investigational Site","condition":"Condition","id":"Study ID","city":"City","state":"State","zip":"Zip","country":"Country"},"studyDesign":"Study Design","designSection":{"purpose":"Primary Purpose","allocation":"Allocation","study_design":"Study Design","study_classification":"Study Classification","masking":"Masking","masked_subject":"Masked Subject","masked_caregiver":"Masked Caregiver","masked_investigator":"Masked Investigator","masked_assessor":"Masked Assessor","primary_outcomes":"Primary Outcomes","secondary_outcomes":"Secondary Outcomes","arms":"Arms","interventions":"Interventions","keyword":"Keyword","inclusionTitle":"Inclusion Criteria","exclusionTitle":"Exclusion Criteria","criteriaText":"Inclusion/Exclusion Criteria","criteria_button":"Click to view inclusion/exclusion criteria","enrollment":"Enrollment","clinicalPublications":"Clinical Publications"},"popoversText":{"studyId":{"childMarkdownRemark":{"html":"A unique number for a study given by ViiV.
"}},"ctGov":{"childMarkdownRemark":{"html":"This number identifies the study on the US clinicaltrials.gov register. Click this link to go to the entry for this study on Clinicaltrials.gov where you will be able to see protocol and results summaries where available.
"}},"eudraCT":{"childMarkdownRemark":{"html":"This number identifies the study on the EU clinicaltrials.eu register. Click this link to go to the entry for this study on clinicaltrials.eu where you will be able to see protocol and results summaries where available.
"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"","ctis_id":"","HasResults":"false","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"http://","IsFlexibleTrial":false,"IsReleasedToCtGov":"false","MaskingInfo":{"masked_assessor":"true","masked_caregiver":"false","masked_investigator":"true","masked_subject":"true","masking_description":"","no_masking":"false"},"PatientLevelData":"false","SharingIpd":"None","acronym":"","allocation":"Randomized","arm_groups":[{"arm_group_label":"GSK3196165","arm_group_description":"Subjects will receive a total of 8 doses of GSK3196165 over a 12-week treatment period.","arm_type":"Experimental"},{"arm_group_label":"Placebo","arm_group_description":"Subjects will receive a total of 8 doses of placebo over a 12-week treatment period.","arm_type":"Placebo Comparator"}],"assignment":"Parallel Assignment","brief_summary":"24BioProtv2 - This is a randomized, Phase IIa, multicentre, double-blind, placebo-controlled parallel group study with the primary objective to assess the efficacy potential of GSK3196165 on pain, in subjects with active inflammatory hand osteoarthritis (HOA).\n\nApproximately 40 subjects will be enrolled into the study, following a screening period of up to 4 weeks. The total treatment period will be 12 weeks, with the follow up period completing at Week 22. At least 40 subjects will be randomized across the two treatment arms, to either placebo or GSK3196165 in a 1:1 ratio.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"StudyTitle 24BioProtv2 - Test study ID for UAT","conditions":[{"DisplayValue":"Osteoarthritis","DisplayValue_OneLinkTx":"","InternalValue":"CON_OA","LookupValue":"Osteoarthritis","LookupValue_OneLinkTx":""}],"created_date":"08/18/2020 12:10:04","criteria":"Inclusion Criteria:\n - Age >=18 years at the time of signing informed consent.\n - Meets American College of Rheumatology (ACR) classification of osteoarthritis (OA) and have not responded to analgesics (level 1 and 2) or to non-steroidal anti-inflammatory drugs (NSAIDs) for at least 10 days in the past 3 months.\n - Active disease at screening and randomization with at least two swollen and tender proximal interphalangeal (PIP) and/or distal interphalangeal (DIP) joints in the affected hand.\n - Signs of inflammation such as synovitis in the MRI scan of the affected hand.\n - Must have a subject’s self assessment of 24-hour average hand pain intensity at baseline of at least ‘5’ on an 11-point Numerical Rating Scale (NRS, 0-10).\n - Weight >=45 kilogram (kg).\n - Male or female subjects are eligible to participate so long as they meet and agree to abide by the contraceptive criteria.\n - Diffusing capacity of the lung for carbon monoxide (DLCO) >=70% predicted; forced expiratory volume in 1 second (FEV1) >=80% predicted.\n - No evidence of active or latent infection with Mycobacterium tuberculosis (TB).\n\nExclusion Criteria:\n - Pregnant or lactating women.\n - History of any clinically significant inflammatory disease other than inflammatory HOA, especially, but not limited to, rheumatoid arthritis or spondylarthropathies.\n - Diagnosis of rheumatoid arthritis, fibromyalgia, gout, calcium pyrophosphate deposition disease (CPPD), pseudogout, hemochromatosis or other inflammatory rheumatological or autoimmune disorders.\n - Clinical suspicion of, or previous investigation for CPPD or pseudogout, or history of chondrocalcinosis.\n - Any injury, medical or surgical procedure to the affected joint(s) that may interfere with evaluation of the target HOA joint(s).\n - History of infected joint prosthesis at any time, with the prosthesis still in situ. History of leg ulcers, catheters, chronic sinusitis or recurrent chest or urinary tract infections.\n - Any surgical procedure, including bone or joint surgery/synovectomy within 12 weeks prior to Day 1 or any planned surgery within the duration of the study or follow-up period.\n - History of any respiratory disease which (in the opinion of the investigator) would compromise subject safety or the ability of the subject to complete the study (e.g. significant interstitial lung disease, such as pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), moderate-severe asthma, bronchiectasis, previous pulmonary alveolar proteinosis [PAP]).\n - Clinically-significant or unstable (in the opinion of the investigator) persistent cough or dyspnea that is unexplained.\n - Significant unstable or uncontrolled acute or chronic disease which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.\n - A history of malignancy.\n - Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency.\n - Current/previous Hepatitis B virus (HBV), Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) 1 or 2 infection.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 2","display_phase_internal":"PHASE_2","display_status":"Active, not recruiting","display_status_internal":"RECSTATUS_I_ACTIVE_NOT_REC","endpoint":"","enrollment":"44","exclusion":"","gender":"All","gender_based":"","gender_description":"","healthy_volunteers":"No","id":"d8eeab65-db31-56cd-826e-3336cedff713","internal":{"content":null,"contentDigest":"7aa622f854c77283e27afd5a8cf50503","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria:\n - Age >=18 years at the time of signing informed consent.\n - Meets American College of Rheumatology (ACR) classification of osteoarthritis (OA) and have not responded to analgesics (level 1 and 2) or to non-steroidal anti-inflammatory drugs (NSAIDs) for at least 10 days in the past 3 months.\n - Active disease at screening and randomization with at least two swollen and tender proximal interphalangeal (PIP) and/or distal interphalangeal (DIP) joints in the affected hand.\n - Signs of inflammation such as synovitis in the MRI scan of the affected hand.\n - Must have a subject’s self assessment of 24-hour average hand pain intensity at baseline of at least ‘5’ on an 11-point Numerical Rating Scale (NRS, 0-10).\n - Weight >=45 kilogram (kg).\n - Male or female subjects are eligible to participate so long as they meet and agree to abide by the contraceptive criteria.\n - Diffusing capacity of the lung for carbon monoxide (DLCO) >=70% predicted; forced expiratory volume in 1 second (FEV1) >=80% predicted.\n - No evidence of active or latent infection with Mycobacterium tuberculosis (TB).\n\nExclusion Criteria:\n - Pregnant or lactating women.\n - History of any clinically significant inflammatory disease other than inflammatory HOA, especially, but not limited to, rheumatoid arthritis or spondylarthropathies.\n - Diagnosis of rheumatoid arthritis, fibromyalgia, gout, calcium pyrophosphate deposition disease (CPPD), pseudogout, hemochromatosis or other inflammatory rheumatological or autoimmune disorders.\n - Clinical suspicion of, or previous investigation for CPPD or pseudogout, or history of chondrocalcinosis.\n - Any injury, medical or surgical procedure to the affected joint(s) that may interfere with evaluation of the target HOA joint(s).\n - History of infected joint prosthesis at any time, with the prosthesis still in situ. History of leg ulcers, catheters, chronic sinusitis or recurrent chest or urinary tract infections.\n - Any surgical procedure, including bone or joint surgery/synovectomy within 12 weeks prior to Day 1 or any planned surgery within the duration of the study or follow-up period.\n - History of any respiratory disease which (in the opinion of the investigator) would compromise subject safety or the ability of the subject to complete the study (e.g. significant interstitial lung disease, such as pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), moderate-severe asthma, bronchiectasis, previous pulmonary alveolar proteinosis [PAP]).\n - Clinically-significant or unstable (in the opinion of the investigator) persistent cough or dyspnea that is unexplained.\n - Significant unstable or uncontrolled acute or chronic disease which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.\n - A history of malignancy.\n - Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency.\n - Current/previous Hepatitis B virus (HBV), Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) 1 or 2 infection.","interventions":[{"arm_group_label":"GSK3196165","intervention_description":"GSK3196165 will be supplied as a liquid and will be administered as a subcutaneous injection. The drug will be administered weekly for 5 injections, then every other week for 3 further injections.","intervention_name":"GSK3196165","intervention_type":"Drug"},{"arm_group_label":"Placebo","intervention_description":"Matching placebo will be administered as above.","intervention_name":"Placebo","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["Pain intensity","Hand Osteoarthritis","GSK3196165","AUSCAN","GM-CSF","Numerical Rating Scale"],"last_follow_up_date":"08/13/2021 00:00:00","links":[],"locations":[{"City":"Bialystok","Latitude":"53.1324886","CountryDisplay":"Poland","Longitude":"23.1688403","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"15-879","StatusDisplay":"Active, not recruiting","StatusDisplayInternal":"LOCSTATUS_ACTIVE_NOT_REC","StatusMapped":"Recruitment Complete"}],"masking":"","maximum_age_raw":"N/A","maximum_age":"N/A","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"08/18/2020 12:10:04","number_of_arms":"2","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"Title 24BioProtv2 - Study for UAT August 2020","org_study_id":"24BioProtv2","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Active, not recruiting - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"No","fda_regulated_drug":"No","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 2","primary_compl_date":"08/13/2021 00:00:00","primary_outcomes":[{"outcome_description":"Measured by daily pain Numerical Rating Scale (NRS) averaged over the 7 days prior to assessment visit.","outcome_measure":"Change from baseline in 24-hour average hand pain intensity at Week 6","outcome_time_frame":"Baseline and Week 6","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[{"id":"","id_type":"","id_domain":""}],"secondary_outcomes":[{"outcome_description":"Measured by daily pain Numerical Rating Scale (NRS) and averaged over the 7 days prior to each assessment visit.","outcome_measure":"Change from baseline in 24-hour average and worst hand pain intensity at each visit","outcome_time_frame":"Baseline through follow-up (Day 155)","outcome_safety_issue":null},{"outcome_description":"Measured by daily NRS averaged over the 7 days prior to assessment visit.","outcome_measure":"Proportion of subjects in each treatment group achieving a 30% or 50% reduction in 24-hour average or worst hand pain intensity at each visit","outcome_time_frame":"Baseline through follow-up (Day 155)","outcome_safety_issue":null},{"outcome_description":"AUSCAN total and domains (pain, morning stiffness, function) scores at each visit will be assessed.","outcome_measure":"Change from baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS","outcome_time_frame":"Baseline through Day 85","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Change in number of swollen and tender hand joints at each visit","outcome_time_frame":"Baseline through follow-up (Day 155)","outcome_safety_issue":null},{"outcome_description":"Patient global assessment will be completed by the subject, the physician global assessment will be completed by the clinician. Both measures are single Numerical Rating Scale (NRS) questions administered via an electronic device.","outcome_measure":"Change from baseline in patient global assessment (PtGA) and physician global assessment (PhGA) of disease activity","outcome_time_frame":"Baseline through follow-up (Day 155)","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Incidence of adverse events and serious adverse events, including infections and pulmonary events","outcome_time_frame":"Baseline through follow-up (Day 155)","outcome_safety_issue":null},{"outcome_description":"Serum samples will be tested, as a measure of immunogenicity.","outcome_measure":"Anti-GSK3196165 antibodies","outcome_time_frame":"Baseline through Day 85","outcome_safety_issue":null},{"outcome_description":"Total body clearance from plasma (CL/F)","outcome_measure":"Population pharmacokinetics - total body clearance from plasms","outcome_time_frame":"Day 1 through Day 43","outcome_safety_issue":null},{"outcome_description":"Total volume of distribution (Vss/F)","outcome_measure":"Population pharmacokinetics - total volume distribution","outcome_time_frame":"Day 1 through Day 43","outcome_safety_issue":null},{"outcome_description":"Absorption rate constant (Ka)","outcome_measure":"Population pharmacokinetics - absorption rate constant","outcome_time_frame":"Day 1 through Day 43","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":[]},"start_date":"08/13/2020 00:00:00","study_type":"Interventional","therapeutic_area":"","citations":[],"is_section_801":null}},"pageContext":{"studyId":"24BioProtv2"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}