[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07037901":3,"trial-entities:NCT07037901":334,"trial-summary:NCT07037901":337},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":54,"secondary_outcomes":58,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":91,"locations":94,"central_contacts":325,"overall_officials":331,"references":332,"see_also_links":333},"NCT07037901","IMG-007-203","A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis","A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis","RECRUITING","2028-08","2026-08","2026-08-12","2025-06-17","Inmagene LLC","INDUSTRY",true,"The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.","A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 48 weeks.",[19,20,21],"Atopic Dermatitis","Atopic Dermatitis Eczema","Eczema",[23,19,24,25,21,26,27,28],"IMG-007","Dermatitis, Atopic","Dermatitis","Skin Diseases","Immune System Diseases","Dermatologic Agents","INTERVENTIONAL","TREATMENT",[32],"PHASE2",{"count":34,"type":35},405,"ESTIMATED",[37,50],{"type":38,"name":23,"description":39,"armGroupLabels":40},"DRUG","Participants will receive IMG-007 subcutaneously.",[41,42,43,44,45,46,47,48,49],"IMG-007 Dose 1","IMG-007 Dose 2","IMG-007 Dose 3","IMG-007 Dose 4","IMG-007 Dose 5","IMG-007 Dose 6","IMG-007 Dose 7","Placebo Crossover Dose 1","Placebo Crossover Dose 2",{"type":38,"name":51,"description":52,"armGroupLabels":53},"Placebo","Participants will receive a placebo subcutaneously.",[48,49],[55],{"measure":56,"timeFrame":57},"Mean percent change from baseline in EASI at Week 24","Baseline, Week 24",[59,61,63,65],{"measure":60,"timeFrame":57},"Proportion of participants achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction from baseline at Week 24",{"measure":62,"timeFrame":57},"Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 24",{"measure":64,"timeFrame":57},"Proportion of participants achieving a ≥ 90% reduction in EASI (EASI-90) at Week 24",{"measure":66,"timeFrame":67},"Incidence and severity of TEAE including treatment-emergent SAEs","Baseline, End of Study","ALL","18 Years","74 Years",false,{"inclusion":73,"exclusion":82,"raw_text":90},[74,75,76,77,78,79,80,81],"Moderate-to-severe AD","Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable","Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception","Male participants must agree to use a highly effective method of contraception","EASI score ≥16","vIGA-AD score ≥3","≥10% body surface area (BSA) of AD involvement","Mean peak pruritus numerical rating scale ≥ 4 during 7-days before randomization",[83,84,85,86,87,88,89],"Positive hepatitis B, hepatitis C, or human immunodeficiency virus infection","Evidence of active or latent tuberculosis (TB)","History of untreated or inadequately treated TB infection","Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals","Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement","Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study","Having received any of the specified therapies within the specified timeframe(s) prior to the Baseline visit","Key Inclusion Criteria:\n\n* Moderate-to-severe AD\n* Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable\n* Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception\n* Male participants must agree to use a highly effective method of contraception\n* EASI score ≥16\n* vIGA-AD score ≥3\n* ≥10% body surface area (BSA) of AD involvement\n* Mean peak pruritus numerical rating scale ≥ 4 during 7-days before randomization\n\nKey Exclusion Criteria:\n\n* Positive hepatitis B, hepatitis C, or human immunodeficiency virus infection\n* Evidence of active or latent tuberculosis (TB)\n* History of untreated or inadequately treated TB infection\n* Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals\n* Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement\n* Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study\n* Having received any of the specified therapies within the specified timeframe(s) prior to the Baseline visit",[92,93],"ADULT","OLDER_ADULT",[95,104,111,119,126,134,142,147,154,162,170,178,185,193,201,209,217,224,232,240,248,255,264,271,279,286,293,301,309,318],{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":100,"geoPoint":101},"Inmagene Site 1","Lancaster","California","93534","United States",{"lat":102,"lon":103},34.69804,-118.13674,{"facility":105,"status":8,"city":106,"state":98,"zip":107,"country":100,"geoPoint":108},"Inmagene Site 23","Los Angeles","90095",{"lat":109,"lon":110},34.05223,-118.24368,{"facility":112,"status":8,"city":113,"state":114,"zip":115,"country":100,"geoPoint":116},"Inmagene Site 19","Ocala","Florida","34470",{"lat":117,"lon":118},29.1872,-82.14009,{"facility":120,"status":8,"city":121,"state":114,"zip":122,"country":100,"geoPoint":123},"Inmagene Site 4","Tampa","33609",{"lat":124,"lon":125},27.94752,-82.45843,{"facility":127,"status":8,"city":128,"state":129,"zip":130,"country":100,"geoPoint":131},"Inmagene Site 2","Rolling Meadows","Illinois","60008",{"lat":132,"lon":133},42.08419,-88.01313,{"facility":135,"status":8,"city":136,"state":137,"zip":138,"country":100,"geoPoint":139},"Inmagene Site 6","Kew Gardens","New York","11415",{"lat":140,"lon":141},40.71427,-73.83097,{"facility":143,"status":8,"city":137,"state":137,"zip":144,"country":100,"geoPoint":145},"Inmagene Site 21","10029",{"lat":140,"lon":146},-74.00597,{"facility":148,"status":8,"city":149,"state":137,"zip":150,"country":100,"geoPoint":151},"Inmagene Site 11","Woodbury","11797",{"lat":152,"lon":153},41.36454,-74.10598,{"facility":155,"status":8,"city":156,"state":157,"zip":158,"country":100,"geoPoint":159},"Inmagene Site 20","Charlotte","North Carolina","28277",{"lat":160,"lon":161},35.22709,-80.84313,{"facility":163,"status":8,"city":164,"state":165,"zip":166,"country":100,"geoPoint":167},"Inmagene Site 10","Fargo","North Dakota","58103",{"lat":168,"lon":169},46.87719,-96.7898,{"facility":171,"status":8,"city":172,"state":173,"zip":174,"country":100,"geoPoint":175},"Inmagene Site 9","Columbus","Ohio","43213",{"lat":176,"lon":177},39.96118,-82.99879,{"facility":179,"status":8,"city":180,"state":173,"zip":181,"country":100,"geoPoint":182},"Inmagene Site 5","Mayfield Heights","44124",{"lat":183,"lon":184},41.51922,-81.4579,{"facility":186,"status":8,"city":187,"state":188,"zip":189,"country":100,"geoPoint":190},"Inmagene Site 3","Portland","Oregon","97210",{"lat":191,"lon":192},45.52345,-122.67621,{"facility":194,"status":8,"city":195,"state":196,"zip":197,"country":100,"geoPoint":198},"Inmagene Site 12","Anderson","South Carolina","29621",{"lat":199,"lon":200},34.50344,-82.65013,{"facility":202,"status":8,"city":203,"state":204,"zip":205,"country":100,"geoPoint":206},"Inmagene Site 8","Southlake","Texas","76092",{"lat":207,"lon":208},32.94124,-97.13418,{"facility":210,"status":8,"city":211,"state":212,"zip":213,"country":100,"geoPoint":214},"Inmagene Site 7","Burien","Washington","698168",{"lat":215,"lon":216},47.47038,-122.34679,{"facility":218,"status":219,"city":220,"state":221,"zip":222,"country":223},"Inmagene Site 25","NOT_YET_RECRUITING","Woden","Australian Capital Territory","2606","Australia",{"facility":225,"status":219,"city":226,"state":227,"zip":228,"country":223,"geoPoint":229},"Inmagene Site 28","Liverpool","New South Wales","2170",{"lat":230,"lon":231},-33.91938,150.92588,{"facility":233,"status":219,"city":234,"state":235,"zip":236,"country":223,"geoPoint":237},"Inmagene Site 26","Benowa","Queensland","4217",{"lat":238,"lon":239},-28.0077,153.38583,{"facility":241,"status":219,"city":242,"state":243,"zip":244,"country":223,"geoPoint":245},"Inmagene Site 27","Carlton","Victoria","3053",{"lat":246,"lon":247},-37.8,144.96667,{"facility":249,"status":219,"city":250,"state":243,"zip":251,"country":223,"geoPoint":252},"Inmagene Site 24","Mitcham","3132",{"lat":253,"lon":254},-37.81667,145.2,{"facility":256,"status":8,"city":257,"state":258,"zip":259,"country":260,"geoPoint":261},"Inmagene Site 15","Surrey","British Columbia","V3R 6A7","Canada",{"lat":262,"lon":263},49.10635,-122.82509,{"facility":265,"status":8,"city":266,"state":258,"zip":267,"country":260,"geoPoint":268},"Inmagene Site 22","Vancouver","V6H 4B1",{"lat":269,"lon":270},49.24966,-123.11934,{"facility":272,"status":8,"city":273,"state":274,"zip":275,"country":260,"geoPoint":276},"Inmagene Site 17","Greater Sudbury","Ontario","P3C 1X8",{"lat":277,"lon":278},46.49,-80.99001,{"facility":280,"status":8,"city":281,"state":274,"zip":282,"country":260,"geoPoint":283},"Inmagene Site 13","Mississauga","L4Y 4C5",{"lat":284,"lon":285},43.5789,-79.6583,{"facility":287,"status":8,"city":288,"state":274,"zip":289,"country":260,"geoPoint":290},"Inmagene Site 18","North Bay","P1B 3Z7",{"lat":291,"lon":292},46.3168,-79.46633,{"facility":294,"status":8,"city":295,"state":296,"zip":297,"country":260,"geoPoint":298},"Inmagene Site 14","Montreal","Quebec","H2X 2V1",{"lat":299,"lon":300},45.50884,-73.58781,{"facility":302,"status":8,"city":303,"state":304,"zip":305,"country":260,"geoPoint":306},"Inmagene Site 16","Saskatoon","Saskatchewan","S7K 2C1",{"lat":307,"lon":308},52.13238,-106.66892,{"facility":310,"status":219,"city":311,"state":312,"zip":313,"country":314,"geoPoint":315},"Inmagene Site 29","Hamilton","Waikato Region","3204","New Zealand",{"lat":316,"lon":317},-37.78333,175.28333,{"facility":319,"status":219,"city":320,"zip":321,"country":314,"geoPoint":322},"Inmagene Site 30","Auckland","1051",{"lat":323,"lon":324},-36.84853,174.76349,[326],{"name":327,"role":328,"phone":329,"email":330},"ADAPTIVE Study Lead","CONTACT","(858) 345-6927","ADAPTIVE_StudyLead@imagenebio.com",[],[],[],{"nct_id":4,"conditions":335,"biomarkers":336},[19],[],{"nct_id":4,"found":15,"summary":338,"prompt_version":348},{"design":339,"status":340,"heading":341,"summary":342,"follow_up":343,"word_count":344,"commitments":345,"compensation":346,"drugs_mentioned":347},"This is a Phase 2b, randomized, double-blind study, meaning participants will be randomly assigned to receive either IMG-007 or a placebo, and neither you nor your doctor will know which you are receiving. The study will include about 405 adult participants.","completed","A Study of IMG-007 for Moderate-to-Severe Atopic Dermatitis","This study is testing a new treatment called IMG-007 for adults with moderate-to-severe atopic dermatitis (eczema). Researchers want to see how well IMG-007 works and if it's safe compared to a placebo (an inactive substance). You might be able to join if you are between 18 and 74 years old and have moderate-to-severe atopic dermatitis that hasn't responded well to topical treatments. The main goal is to see how much your eczema improves after 24 weeks of treatment. The study plans to enroll 405 participants, but its current recruitment status is unclear.","The main treatment period is up to 48 weeks, with the primary outcome measured at Week 24.",92,"Not specified in the trial record.","Not stated in the trial record.",[23,51],"v2"]