[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Idorsia Pharmaceuticals Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100644043","phase-2-a-study-to-learn-how-safe-act-777991-is-and-how-well-it-works-in-adults-with-non-segmental-vitiligo-100644043",false,"NCT07667569","A Study to Learn How Safe ACT-777991 is and How Well it Works in Adults With Non-segmental Vitiligo","A Phase 2a, Proof of Concept, Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial to Assess the Efficacy and Safety of ACT-777991 in Adults With Non-segmental Vitiligo","Inclusion Criteria:\n\n* Clinical diagnosis of either active or stable non segmental vitiligo for at least 3 months prior to Screening and meet all the following criteria:\n\n  * F-VASI score ≥ 0.3 based on BICR at Screening.\n  * T-VASI score ≥ 5 based on investigator assessment at Screening and Randomization.\n  * Total body surface area (BSA) involvement, including the face, ≤ 50% based on investigator assessment at Screening and Randomization.\n* Participants must agree not to use therapeutic agents and procedures to treat vitiligo from Screening until Participant Last Visit.\n\nExclusion Criteria:\n\n* Clinical diagnosis of other forms of vitiligo (e.g., segmental) or other hypo- or depigmentation disorders (e.g., piebaldism, leukoderma, Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation).\n* Any autoimmune disease, except adequately treated thyroid disease.\n* History of systemic immunotherapy treatment, including JAK inhibitors, for any inflammatory disease in the 12 months prior to Randomization.\n* History of topical JAK inhibitors for any inflammatory disease in the 6 weeks prior to Screening.\n* Use of laser or light-based treatment (phototherapy), including tanning beds, in the 8 weeks prior to Screening.\n* eGFR \\\u003C 90 mL\u002Fmin\u002F1.73 m2, defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, at Screening.","ALL","18 Years","65 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this clinical trial is to learn how well ACT-777991 works, how safe it is and how well it is tolerated by adults with non-segmental vitiligo.\n\nThe main question this clinical trial aims to answer is:\n\n• Can ACT-777991 help return color to the skin of the face of adults with non-segmental vitiligo?\n\nResearchers will compare ACT-777991 to placebo (a look-alike inactive treatment that contains no medicine) to see if ACT-777991 works to treat non-segmental vitiligo.\n\nTrial participants will:\n\n* Take the trial intervention (either ACT-777991 or placebo) daily for 24 weeks.\n* Visit the clinic 7 times for check-up and tests.",[27],"Non-Segmental Vitiligo","NOT_YET_RECRUITING","2026-06-24",{"date":31,"type":32},"2026-06-25","ACTUAL",{"date":34,"type":21},"2026-06",{"date":36,"type":21},"2027-07",{"name":38,"class":39},"Idorsia Pharmaceuticals Ltd.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100554364","registry-to-collect-information-on-pregnancy-neonatal-and-infant-outcomes-in-pregnant-women-exposed-to-quviviq-100554364","NCT06498128","Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®","QUVIVIQ® Pregnancy Registry","A) Eligibility criteria for prospective pregnancies:\n\nInclusion Criteria:\n\n1. Diagnosis of insomnia disorder prior to pregnancy.\n2. Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.\n3. One of the following:\n\n   1. Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception.\n   2. Exposure to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.\n   3. No exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.\n\nExclusion Criteria:\n\n* Exposure to any orexin receptor antagonist other than QUVIVIQ - including BELSOMRA® (suvorexant), DAYVIGO® (lemborexant), any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during the current pregnancy or within 5 half-lives of the respective medication prior to conception.\n\nB) Eligibility criteria for retrospective pregnancies:\n\nInclusion criteria:\n\n1. Diagnosis of insomnia disorder prior to pregnancy.\n2. Pregnancy has ended.\n3. Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.\n\nExclusion criteria:\n\n* Exposure to any orexin receptor antagonist other than QUVIVIQ - including suvorexant, lemborexant, any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during pregnancy or within 5 half-lives of the respective medication prior to conception.","FEMALE","15 Years","50 Years",{"count":51,"type":21},785,"21 Months","OBSERVATIONAL","This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.",[56],"Insomnia",[58],"Pregnancy","RECRUITING","2025-12-01",{"date":62,"type":32},"2025-12-02",{"date":64,"type":32},"2024-11-21",{"date":66,"type":21},"2033-03",{"name":38,"class":39},7,""]