[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642243":3},{"organization":4,"armGroups":7,"interventions":68,"overallOfficials":74,"centralContacts":79,"locations":86,"responsibleParty":100,"collaborators":74,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":74,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":74,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":89,"whyStopped":74,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14,18,22,26,30,34,38,44,48,52,56,60,64],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1- Cohort A1: Dose Level 1 DCY636","EXPERIMENTAL","Cohort A1: Dose Level 1 DCY636 in healthy participants.",[13],"Drug: DCY636",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1- Cohort A2: Dose Level 2 DCY636","Cohort A2: Dose Level 2 DCY636 in healthy participants.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 1- Cohort A3: Dose Level 3 DCY636","Cohort A3: Dose Level 3 DCY636 in healthy participants.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part 1- Cohort A4: Dose Level 4 DCY636","Cohort A4: Dose Level 4 DCY636 in healthy participants.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Part 1- Cohort B1: Dose Level 5 DCY636","Cohort B1: Dose Level 5 DCY636 in healthy participants.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Part 1- Cohort B2: Dose Level 6 DCY636","Cohort B2: Dose Level 6 DCY636 in healthy participants.",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Part 2- Cohort C1: Dose Level 7 DCY636","Part 2- Cohort C1: Dose Level 7 DCY636 in participants with moderate to severe atopic dermatitis.",[13],{"label":39,"type":40,"description":41,"interventionNames":42},"Part 1- Cohort A1: Placebo","PLACEBO_COMPARATOR","Cohort A1: Placebo in healthy participants.",[43],"Drug: Placebo",{"label":45,"type":40,"description":46,"interventionNames":47},"Part 1- Cohort A2: Placebo","Cohort A2: Placebo in healthy participants.",[43],{"label":49,"type":40,"description":50,"interventionNames":51},"Part 1- Cohort A3: Placebo","Cohort A3: Placebo in healthy participants.",[43],{"label":53,"type":40,"description":54,"interventionNames":55},"Part 1- Cohort A4: Placebo","Cohort A4: Placebo in healthy participants.",[43],{"label":57,"type":40,"description":58,"interventionNames":59},"Part 1- Cohort B1: Placebo","Cohort B1: Placebo in healthy participants.",[43],{"label":61,"type":40,"description":62,"interventionNames":63},"Part 1- Cohort B2: Placebo","Cohort B2: Placebo in healthy participants.",[43],{"label":65,"type":40,"description":66,"interventionNames":67},"Part 2- Cohort C1: Placebo","Part 2- Cohort C1: Placebo in participants with moderate to severe atopic dermatitis.",[43],[69,75],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"DRUG","DCY636","Participants will receive DCY636",[9,15,19,23,27,31,35],null,{"type":70,"name":76,"description":77,"armGroupLabels":78,"otherNames":74},"Placebo","Participants will receive Placebo",[39,45,49,53,57,61,65],[80,85],{"name":81,"role":82,"phone":83,"phoneExt":74,"email":84},"Novartis Pharmaceuticals","CONTACT","+81337978748","novartis.email@novartis.com",{"name":81,"role":82,"phone":74,"phoneExt":74,"email":74},[87],{"facility":88,"status":89,"city":90,"state":74,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":74},"Novartis Investigative Site","RECRUITING","Fukuoka","812-0025","Japan","JP",{"type":95,"coordinates":96},"Point",[97,98],130.41667,33.6,{"lat":98,"lon":97},{"type":101,"investigatorFullName":74,"investigatorTitle":74,"investigatorAffiliation":74,"oldNameTitle":74,"oldOrganization":74},"SPONSOR","100642243","phase-1-a-first-in-human-study-to-investigate-single-doses-of-dcy636-in-healthy-volunteers-and-multiple-doses-in-participants-with-moderate-to-severe-atopic-dermatitis-100642243",false,"NCT07604324","A First-in-human Study to Investigate Single Doses of DCY636 in Healthy Volunteers and Multiple Doses in Participants With Moderate to Severe Atopic Dermatitis","A Two-part, Randomized, Participant- and Investigator-blinded, Placebo Controlled First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of DCY636 in a Single Ascending Dose Part in Healthy Participants and in a Multiple Dose Part in Participants With Moderate to Severe Atopic Dermatitis","Key Inclusion Criteria:\n\nHealthy Participants (Part 1)\n\n• Healthy male and non-childbearing potential female participants 18 to 55 years of age inclusive.\n\nParticipants with moderate to severe atopic dermatitis (Part 2)\n\n* Males and non-pregnant females age 18 years or older\n* Diagnosis of atopic dermatitis for at least 1 year not adequately controlled by topicals\n* Moderate to severe atopic dermatitis as defined by all of the following:\n\n  * EASI score ≥12 at screening visit and ≥16 at baseline (BL) visit\n  * IGA score ≥3 at screening visit and baseline visit\n  * Total Body surface area (BSA) affected by AD ≥ 10 % at screening visit and baseline visit\n  * Peak Pruritus NRS score ≥4 at baseline visit, based on weekly average of daily assessment in the week prior to baseline visit\n\nKey Exclusion Criteria:\n\nAll Participants (Part 1, Part 2)\n\n* Use of other investigational drugs within the last 30 days or 5 half-lives of the other drugs prior to initial dosing, whichever is longer.\n* Meet any of the prohibited medication use criteria at baseline visit.\n* A positive syphilis test result during screening period.\n* Evidence of active or latent TB infection, as determined by T-Spot test during screening period.\n* History of immunodeficiency diseases, or a positive human immunodeficiency virus (HIV) test result.\n* Recent (within last half year) or ongoing helminth infection.\n* History of hepatitis B or hepatitis C or serologic evidence for viral hepatitis. A positive Hepatitis B virus surface antigen (HBsAg), Hepatitis B virus core antibody (HBcAb) and\u002For Hepatitis B surface antibody (HBsAb) test during screening period excludes a participant. A positive test for HBsAb can be included if the test for HBsAg and HBcAb are negative and the history of hepatitis B vaccination is known. Participants with a positive Hepatitis C virus (HCV) antibody test should be excluded.\n\nHealthy Participants (Part 1)\n\n* Women of childbearing potential\n* Smokers Participants with moderate to severe atopic dermatitis (Part 2)\n* Regular use (more than 2 visits per week) of a tanning booth\u002Fparlor or extended sun exposure (per investigator judgement) within 4 weeks prior to baseline visit\n* Have any chronic, uncontrolled medical condition, which would put the participant at increased risk during study participation, such as uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, cardiovascular, pulmonary, hepatic, renal, neurologic or psychiatric disease, or other disease of concern, as per investigator judgment\n* Women of childbearing potential (WOCBP) are excluded unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for 202 days (= 5 times the terminal half-life) of study treatment after stopping study treatment.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",true,"ALL","18 Years","100 Years",{"count":114,"type":115},63,"ESTIMATED","INTERVENTIONAL",[118],"PHASE1","The purpose of this first-in-human (FIH) study is to assess the safety and tolerability, pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) of DCY636. The results are intended to support the further clinical development of DCY636 in future studies.",[121],"Dermatitis, Atopic",[123,124,125,126,127,128,129,130],"Phase 1","FIH","safety and tolerability","healthy volunteers","PK","atopic dermatitis","AD","eczema","2026-06-15",{"date":133,"type":134},"2026-06-16","ACTUAL",{"date":136,"type":134},"2026-06-02",{"date":138,"type":115},"2028-01-28",{"name":81,"class":6},1]