[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07223138":3,"trial-entities:NCT07223138":198,"trial-summary:NCT07223138":201},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":52,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":83,"locations":86,"central_contacts":194,"overall_officials":195,"references":196,"see_also_links":197},"NCT07223138","M1095-PSA-303","A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis","ENROLLING_BY_INVITATION","2028-02-04","2026-06","2026-06-11","2025-11-13","MoonLake Immunotherapeutics AG","INDUSTRY",true,"This is a study to demonstrate the long-term safety, tolerability and clinical efficacy of sonelokimab in the treatment of patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302)","M1095-PSA-303 is a Phase 3, multicenter, open-label extension study to investigate the long-term safety, tolerability and clinical efficacy of sonelokimab 60 mg subcutaneously every 4 weeks in patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302).",[18],"Arthritis, Psoriatic",[20,21,22,23],"Anti-Inflammatory Agents","Sonelokimab","Nanobody","Psoriatic Arthritis","INTERVENTIONAL","TREATMENT",[27],"PHASE3",{"count":29,"type":30},1560,"ESTIMATED",[32],{"type":33,"name":21,"description":34,"armGroupLabels":35},"DRUG","Open-label",[36],"Experimental: sonelokimab dose",[38,42,44,46,48,50],{"measure":39,"description":40,"timeFrame":41},"Long-term safety and tolerability of sonelokimab:","Treatment-emergent adverse events (TEAEs)","52 weeks",{"measure":39,"description":43,"timeFrame":41},"Serious adverse events (SAEs)",{"measure":39,"description":45,"timeFrame":41},"TEAEs leading to study withdrawal",{"measure":39,"description":47,"timeFrame":41},"Adverse events of special interest (AESIs)",{"measure":39,"description":49,"timeFrame":41},"Clinically significant changes in vital signs and standard 12-lead electrocardiogram Measure description: Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline",{"measure":39,"description":51,"timeFrame":41},"Clinically significant changes in clinical laboratory parameters Measure description: Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline",[53,56,58,60,62,64,66,68,70,72],{"measure":54,"description":55,"timeFrame":41},"Long-term efficacy of sonelokimab:","Proportion of participants achieving American College of Rheumatology (ACR) 20\u002F50\u002F70% improvement criteria over time",{"measure":54,"description":57,"timeFrame":41},"Change over time in Minimal disease activity (MDA)",{"measure":54,"description":59,"timeFrame":41},"Change over time in Health assessment questionnaire-disability index (HAQ-DI)",{"measure":54,"description":61,"timeFrame":41},"Change over time in Tender joint count (TJC)68\u002F swollen joint count (SJC)66",{"measure":54,"description":63,"timeFrame":41},"Proportion of participants achieving Psoriasis Area and Severity Index (PASI) 75\u002F90\u002F100 over time",{"measure":54,"description":65,"timeFrame":41},"Change over time in Modified Nail Psoriasis Severity Index (mNAPSI)",{"measure":54,"description":67,"timeFrame":41},"Proportion of participants achieving Very low disease activity (VLDA) over time",{"measure":54,"description":69,"timeFrame":41},"Proportion of participants achieving SpondyloArthritis Research Consortium of Canada (SPARCC) over time",{"measure":54,"description":71,"timeFrame":41},"Change over time in Leeds Enthesitis Index (LEI)",{"measure":73,"description":74,"timeFrame":41},"Long term efficacy of sonelokimab","Proportion of participants achieving both an ACR 50\u002FACR70 and PASI90\u002F100 improvement over time","ALL","18 Years",null,false,{"inclusion":80,"exclusion":81,"raw_text":82},[],[],"Inclusion Criteria:\n\n1. Participants who, in the opinion of the investigator, are expected to benefit from participation in this OLE study.\n2. Participants who have received the second to last and\u002For last dose, as planned in the parental study, and have completed the end-of-treatment visit of the parental study.\n3. Participants must have received their last dose of study treatment in the parental study no more than 8 weeks (but ideally 4 weeks) before the first dose in this OLE study.\n4. Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment.\n5. Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Participants who met any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.\n2. Participants who have ongoing or planned use of one or more of the prohibited PsA or non-PsA treatments specified in this protocol.\n3. Participants who plan to participate in another interventional study for a drug or device during this study.\n4. Participants who were unblinded during the parental study.\n5. 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