[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07223697":3,"trial-entities:NCT07223697":307,"trial-summary:NCT07223697":310},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":44,"sex":70,"minimum_age":71,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":72,"std_ages":82,"locations":85,"central_contacts":290,"overall_officials":298,"references":302,"see_also_links":303},"NCT07223697","CS45943","A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis","An Extension Study To Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Atopic Dermatitis Who Participated in Previous Afimkibart Clinical Trials","RECRUITING","2033-03-01","2026-08","2026-08-06","2026-01-08","Hoffmann-La Roche","INDUSTRY",false,"This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.",null,[19],"Atopic Dermatitis",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},120,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":36},"DRUG","Afimkibart","Afimkibart SC injection will be administered as per the schedule defined in the protocol.",[34,35],"Afimkibart Group I","Afimkibart Group II",[37,38,39],"RO7790121","PF-06480605","RVT-3101",[41],{"measure":42,"timeFrame":43},"Percentage of Participants with Adverse Events","From Baseline up to 6 years",[45,48,50,53,55,57,59,61,63,66,68],{"measure":46,"timeFrame":47},"Change From Baseline (in Parent Study) in Eczema Area and Severity Index (EASI) Score at Each Visit","Baseline, Up to 6 years",{"measure":49,"timeFrame":47},"Percent Change From Baseline (in Parent Study) in EASI Score at Each Visit",{"measure":51,"timeFrame":52},"Percentage of Participants With EASI-50 at Each Visit","Up to 6 years",{"measure":54,"timeFrame":52},"Percentage of Participants with EASI-75 at Each Visit",{"measure":56,"timeFrame":52},"Percentage of Participants with EASI-90 at Each Visit",{"measure":58,"timeFrame":43},"Percentage of Participants who Achieve Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of Clear (0) or Almost clear (1) at Each Visit",{"measure":60,"timeFrame":47},"Change from Baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at Each Visit",{"measure":62,"timeFrame":47},"Change from Baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at Each Visit",{"measure":64,"timeFrame":65},"Serum Concentration of Afimkibart at Specified Timepoints","Pre-dose on Day 1, Weeks 2, 10, 18, 26, 34, 42, 50 74, 98, 122, 146, 170, 194, 218, 242, 266, 290 and 14 weeks after last dose",{"measure":67,"timeFrame":43},"Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart",{"measure":69,"timeFrame":43},"Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart","ALL","18 Years",{"inclusion":73,"exclusion":76,"raw_text":81},[74,75],"Ability and willingness to comply with all aspects of the protocol including completion of the efficacy assessments (EASI and IGA), clinical outcome assessment instruments (DLQI, POEM), and safety and PK sample collections for the duration of the study","Study CS45570 participants who continued to be evaluated at the Week 36 follow up visit and achieved =\\> EASI50 response from study baseline",[77,78,79,80],"Evidence of other skin conditions that would interfere with the assessment of AD","Withdrawal of consent and\u002For premature discontinuation from parent study","Any permanent discontinuation of study drug in parent study","History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of Afimkibart","Inclusion Criteria:\n\n* Ability and willingness to comply with all aspects of the protocol including completion of the efficacy assessments (EASI and IGA), clinical outcome assessment instruments (DLQI, POEM), and safety and PK sample collections for the duration of the study\n\nParent Clinical Trial-Specific Criteria:\n\n* Study CS45570 participants who continued to be evaluated at the Week 36 follow up visit and achieved =\\> EASI50 response from study baseline\n\nExclusion Criteria:\n\n* Evidence of other skin conditions that would interfere with the assessment of AD\n* Withdrawal of consent and\u002For premature discontinuation from parent study\n* Any permanent discontinuation of study drug in parent study\n* History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of Afimkibart",[83,84],"ADULT","OLDER_ADULT",[86,95,103,111,119,127,136,144,148,156,163,167,171,178,187,194,201,208,217,224,233,242,249,256,260,267,274,283],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"geoPoint":92},"UCLA Division of Dermatology","Los Angeles","California","90024","United States",{"lat":93,"lon":94},34.05223,-118.24368,{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":91,"geoPoint":100},"Olympian Clinical Research","Tampa","Florida","33615",{"lat":101,"lon":102},27.94752,-82.45843,{"facility":104,"status":8,"city":105,"state":106,"zip":107,"country":91,"geoPoint":108},"Hamilton Research, LLC","Alpharetta","Georgia","30022",{"lat":109,"lon":110},34.07538,-84.29409,{"facility":112,"status":8,"city":113,"state":114,"zip":115,"country":91,"geoPoint":116},"Revival Research Institute, LLC","Troy","Michigan","48084",{"lat":117,"lon":118},42.60559,-83.14993,{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":91,"geoPoint":124},"Best Skin Research LLC","Camp Hill","Pennsylvania","17011",{"lat":125,"lon":126},40.23981,-76.91997,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":132,"geoPoint":133},"Centro de Estudos em Terapias Inovadoras ? CETI","Curitiba","Paraná","80030-110","Brazil",{"lat":134,"lon":135},-25.42778,-49.27306,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":132,"geoPoint":141},"Irmandade Da Santa Casa de Misericordia de Porto Alegre","Porto Alegre","Rio Grande do Sul","90020-090",{"lat":142,"lon":143},-30.03283,-51.23019,{"facility":145,"status":8,"city":138,"state":139,"zip":146,"country":132,"geoPoint":147},"Hospital de Clnicas de Porto Alegre","90035-903",{"lat":142,"lon":143},{"facility":149,"status":8,"city":150,"state":151,"zip":152,"country":132,"geoPoint":153},"UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu","Botucatu","São Paulo","18618-686",{"lat":154,"lon":155},-22.88583,-48.445,{"facility":157,"status":8,"city":158,"state":151,"zip":159,"country":132,"geoPoint":160},"Centro de Pesquisa São Lucas","Campinas","13060-803",{"lat":161,"lon":162},-22.90556,-47.06083,{"facility":164,"status":8,"city":165,"state":151,"zip":166,"country":132},"HMCG - Hospital e Maternidade Dr. Christovo da Gama","Santo Andr","09030-010",{"facility":168,"status":8,"city":169,"state":151,"zip":170,"country":132},"Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS","Sao Jose Rio Preto","15090-000",{"facility":172,"status":8,"city":173,"zip":174,"country":132,"geoPoint":175},"Instituto Brasil de Pesquisa Clínica-IBPCLIN S\u002FA","Rio de Janeiro","20241-180",{"lat":176,"lon":177},-22.90642,-43.18223,{"facility":179,"status":8,"city":180,"state":181,"zip":182,"country":183,"geoPoint":184},"DermEffects","London","Ontario","N6H 5L5","Canada",{"lat":185,"lon":186},42.98339,-81.23304,{"facility":188,"status":8,"city":189,"state":181,"zip":190,"country":183,"geoPoint":191},"Lynderm Research Inc","Markham","L3P 1X3",{"lat":192,"lon":193},43.86682,-79.2663,{"facility":195,"status":8,"city":196,"state":181,"zip":197,"country":183,"geoPoint":198},"DermEdge","Mississauga","L4Y4C5",{"lat":199,"lon":200},43.5789,-79.6583,{"facility":202,"status":8,"city":203,"state":181,"zip":204,"country":183,"geoPoint":205},"Ryan Clinical Research Inc","Newmarket","L3Y 5G8",{"lat":206,"lon":207},44.05011,-79.46631,{"facility":209,"status":8,"city":210,"state":211,"zip":212,"country":213,"geoPoint":214},"Fachklinik Bad Bentheim","Bad Bentheim","Lower Saxony","48455","Germany",{"lat":215,"lon":216},52.30066,7.15763,{"facility":218,"status":8,"city":219,"zip":220,"country":213,"geoPoint":221},"Dermatologikum Hamburg Gemeinschaftspraxis GbR","Hamburg","20354",{"lat":222,"lon":223},53.55073,9.99302,{"facility":225,"status":8,"city":226,"state":227,"zip":228,"country":229,"geoPoint":230},"Azienda Ospedaliero Universitaria delle Marche","Ancona","The Marches","60126","Italy",{"lat":231,"lon":232},43.60717,13.5103,{"facility":234,"status":8,"city":235,"state":236,"zip":237,"country":238,"geoPoint":239},"Centrum Medyczne Pratia Katowice I","Katowice","Silesian Voivodeship","40-081","Poland",{"lat":240,"lon":241},50.2597,19.02173,{"facility":243,"status":8,"city":244,"zip":245,"country":238,"geoPoint":246},"Centrum Medyczne Pratia Gdynia","Gdynia","81-338",{"lat":247,"lon":248},54.51889,18.53188,{"facility":250,"status":8,"city":251,"zip":252,"country":238,"geoPoint":253},"Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski","Krakow","30-002",{"lat":254,"lon":255},50.06143,19.93658,{"facility":257,"status":8,"city":251,"zip":258,"country":238,"geoPoint":259},"Centrum Nowoczesnych Terapii \"Dobry Lekarz\"","31-011",{"lat":254,"lon":255},{"facility":261,"status":8,"city":262,"zip":263,"country":238,"geoPoint":264},"Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie","Rzeszów","35-055",{"lat":265,"lon":266},50.04132,21.99901,{"facility":268,"status":8,"city":269,"zip":270,"country":238,"geoPoint":271},"Klinika Ambroziak Dermatologia","Warsaw","02-953",{"lat":272,"lon":273},52.22977,21.01178,{"facility":275,"status":8,"city":276,"state":277,"zip":278,"country":279,"geoPoint":280},"Clinica Universidad de Navarra","Pamplona","Navarre","31008","Spain",{"lat":281,"lon":282},42.81687,-1.64323,{"facility":284,"status":8,"city":285,"zip":286,"country":279,"geoPoint":287},"Hospital Universitario Reina Sofia","Córdoba","14004",{"lat":288,"lon":289},37.89155,-4.77275,[291,296],{"name":292,"role":293,"phone":294,"email":295},"Reference Study ID Number: CS45943 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. Only)","global-roche-genentech-trials@gene.com",{"name":297,"role":293},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[299],{"name":300,"affiliation":13,"role":301},"Clinical Trials","STUDY_DIRECTOR",[],[304],{"label":305,"url":306},"Please use this form to submit your questions for a faster response: https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.","https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"nct_id":4,"conditions":308,"biomarkers":309},[19],[],{"nct_id":4,"found":311,"summary":312,"prompt_version":322},true,{"design":313,"status":314,"heading":315,"summary":316,"follow_up":317,"word_count":318,"commitments":319,"compensation":320,"drugs_mentioned":321},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 120 participants.","completed","Long-Term Study of Afimkibart for Atopic Dermatitis","This study is looking at the long-term safety and how well Afimkibart (also known as RO7790121) works for people with Atopic Dermatitis (a chronic skin condition causing itchy and inflamed skin). You might be able to join if you are an adult (18 years or older) and have already participated in a previous clinical trial for Afimkibart (specifically, study CS45570). The main goal is to track any side effects over a long period, up to 6 years. This study is currently unclear about its recruitment status and plans to include about 120 participants.","Participants will be followed for adverse events (side effects) from the start of the study for up to 6 years.",93,"You would receive Afimkibart as a subcutaneous (under the skin) injection according to a set schedule. You would also complete assessments for how well the treatment works (EASI and IGA), quality of life (DLQI, POEM), and provide samples for safety and drug levels (PK).","Not stated in the trial record.",[31],"v2"]