[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07733765":3,"trial-entities:NCT07733765":212,"trial-summary:NCT07733765":216},{"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":44,"secondary_outcomes":48,"sex":151,"minimum_age":152,"maximum_age":17,"healthy_volunteers":153,"eligibility_criteria":154,"std_ages":165,"locations":169,"central_contacts":198,"overall_officials":204,"references":207,"see_also_links":208},"NCT07733765","B7981110","A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata","A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE ALOPECIA AREATA","NOT_YET_RECRUITING","2028-04-27","2026-07","2026-07-29","2026-07-31","Pfizer","INDUSTRY",true,"The purpose of this clinical study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the potential treatment of moderate alopecia areata (AA).\n\nThis study is seeking participants who are\n\n* 12 years or older (if permitted by the local IRB\u002FEC and local regulatory health authority)\n* have AA with patchy hair loss. The current episode of hair loss has lasted for 6 months or longer but 10 years or less\n* do not have any other diseases or conditions affecting hair loss.\n\nParticipants will have a 2 in 3 chance of receiving ritlecitinib 50 mg and a 1 in 3 chance of receiving placebo. The placebo looks like the study medicine but does not contain any active ingredients. Participants will not know what you have been assigned to receive. They will take ritlecitinib or placebo once daily by mouth at home for 24 weeks (6 months). After 24 weeks, the assigned treatment may stay the same or be changed to ritlecitinib 50 mg or 100 mg. This change will depend on how participants' alopecia areata responds to the treatment. Participants will receive the newly assigned treatment for another 23 weeks.\n\nAbout 4 weeks after the last dose, there will be a follow-up visit. At this visit, the team will check on your health. Participants will take part in this study for about 57 weeks. During this time, they will have study visits at the study clinic. Some study checks will be done by phone.\n\nWe will compare the experiences of people receiving ritlecitinib to those of people who do not. This will help us determine if ritlecitinib is safe and effective.",null,[19],"Alopecia Areata",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},336,"ESTIMATED",[29,36,40],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Ritlecitinib 100 mg","100 mg capsule taken orally once daily",[34,35],"Placebo","Ritlecitinib 50 milligrams (mg)",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Ritlecitinib 50 mg","50 mg capsule taken orally once daily",[34,35],{"type":41,"name":34,"description":42,"armGroupLabels":43},"OTHER","Capsule matching either 50mg or 100 mg ritlecitinib capsule taken orally once daily",[34],[45],{"measure":46,"timeFrame":47},"Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo","Week 24",[49,51,53,55,57,60,62,65,67,69,71,73,75,78,80,82,84,86,88,90,93,97,100,102,104,106,108,110,112,114,116,118,120,122,124,126,128,130,132,134,136,138,140,142,144,146,148],{"measure":50,"timeFrame":47},"Difference in the proportion of SALT ≤5 responders at Week 24 between ritlecitinib 50 mg QD versus",{"measure":52,"timeFrame":47},"Difference in the proportion of SALT ≤10 responders at Week 24 between ritlecitinib 50 mg QD versus",{"measure":54,"timeFrame":47},"Difference in the proportion of SALT 75 responders at Week 24 between ritlecitinib 50 mg QD versus",{"measure":56,"timeFrame":47},"Difference in the proportion of SALT 90 responders at Week 24 between ritlecitinib 50 mg QD versus",{"measure":58,"timeFrame":59},"Difference in the mean change from baseline (CFB) in SALT score at applicable timepoints through Week 24 for ritlecitinib 50 mg QD versus placebo","Weeks 8, 12, 18 and 24",{"measure":61,"timeFrame":47},"Difference in the proportion of Patient Global Impression of Change (PGI-C) responders at Week 24 between ritlecitinib 50 mg QD versus placebo",{"measure":63,"timeFrame":64},"Difference in the proportion of SALT 0 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo","Weeks 8, 12, 18",{"measure":66,"timeFrame":64},"Difference in the proportion of SALT ≤10 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo",{"measure":68,"timeFrame":64},"Difference in the proportion of SALT ≤5 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo",{"measure":70,"timeFrame":64},"Difference in the proportion of SALT 75 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo",{"measure":72,"timeFrame":64},"Difference in the proportion of SALT 90 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo",{"measure":74,"timeFrame":64},"Difference in the mean CFB in SALT score at applicable timepoints between ritlecitinib 50 mg QD versus placebo",{"measure":76,"timeFrame":77},"Difference in the proportion of Eyebrow Assessment (EBA) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo","Weeks 8, 12, 18, 24",{"measure":79,"timeFrame":77},"Difference in the proportion of Eyelash Assessment (ELA) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo",{"measure":81,"timeFrame":64},"Difference in the proportion of PGI-C responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo",{"measure":83,"timeFrame":77},"Difference in the proportion of Patient's Satisfaction with Hair Growth (P-SAT) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo",{"measure":85,"timeFrame":77},"Difference in the proportion of Improvement in hair loss on each of the Alopecia Areata Patient Priority Outcomes (AAPPO) items 1-4 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo",{"measure":87,"timeFrame":77},"Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo",{"measure":89,"timeFrame":77},"Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo",{"measure":91,"timeFrame":92},"Proportion of participants with treatment emergent AEs, SAEs, and adverse events leading to discontinuation including those collected during the safety follow-up period","Screening to Follow up period (up to week 57)",{"measure":94,"description":95,"timeFrame":96},"Proportion of responders for SALT 0 at appliable timepoints after Week 24","For each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)","Weeks 28, 36, and 48",{"measure":98,"description":99,"timeFrame":96},"Proportion of responders for SALT ≤10 at appliable timepoints after Week 24","for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)",{"measure":101,"description":99,"timeFrame":96},"Proportion of responders for SALT ≤5 at appliable timepoints after Week 24",{"measure":103,"description":99,"timeFrame":96},"Proportion of responders for SALT 75 at appliable timepoints after Week 24",{"measure":105,"description":99,"timeFrame":96},"Proportion of responders for SALT 90 at appliable timepoints after Week 24",{"measure":107,"timeFrame":96},"Difference in the proportion of SALT 0 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":109,"timeFrame":96},"Difference in the proportion of SALT≤10 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":111,"timeFrame":96},"Difference in the proportion of SALT≤5 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":113,"timeFrame":96},"Difference in the proportion of SALT75 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":115,"timeFrame":96},"Difference in the proportion of SALT90 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":117,"description":99,"timeFrame":96},"Mean CFB in SALT score at applicable timepoints after Week 24",{"measure":119,"timeFrame":96},"Difference in the mean CFB in SALT score at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":121,"description":99,"timeFrame":96},"Proportion of responders for EBA at appliable timepoints after Week 24",{"measure":123,"description":99,"timeFrame":96},"Proportion of responders for ELA at appliable timepoints after Week 24",{"measure":125,"timeFrame":96},"Difference in the proportion of EBA responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":127,"timeFrame":96},"Difference in the proportion of ELA responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":129,"description":99,"timeFrame":96},"Proportion of PGI-C responders at applicable timepoints after Week 24",{"measure":131,"description":99,"timeFrame":96},"Proportion of P-Sat responders at applicable timepoints after Week 24",{"measure":133,"description":99,"timeFrame":96},"Proportion of responders for Improvement in hair loss on each of the AAPPO items 1-4 at applicable timepoints after Week 24",{"measure":135,"description":99,"timeFrame":96},"Proportion of responders for Improvement in Emotional Symptoms on each of the AAPPO items 5-8 at applicable timepoints after Week 24",{"measure":137,"description":99,"timeFrame":96},"Proportion of responders for Improvement in Activity Limitations on each of the AAPPO items 9-1 1 responders at applicable timepoints after Week 24",{"measure":139,"timeFrame":96},"Difference in the proportion of PGI-C responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":141,"timeFrame":96},"Difference in the proportion of P-SAT responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":143,"timeFrame":96},"Difference in the proportion of Improvement in hair loss on each of the AAPPO items 1-4 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":145,"timeFrame":96},"Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":147,"timeFrame":96},"Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group",{"measure":149,"timeFrame":150},"Proportion of participants with clinically significant abnormalities in clinical laboratory test values including those collected during the safety follow-up period","Screening to Follow up period (up to 57 weeks)","ALL","12 Years",false,{"inclusion":155,"exclusion":160,"raw_text":164},[156,157,158,159],"18 years or older (or the minimum age of consent in accordance with local regulations) at screening. Adolescents (12 to \\\u003C18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB\u002FEC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled","Have a clinical diagnosis of AA with no other etiology of hair loss.","Have \\>20% to \\\u003C50% hair loss of the scalp, as measured by SALT.","Current AA episode of hair loss ≥6 months and ≤10 years (Current episode is defined as the continuous period of AA-related scalp hair loss since the last time the subject had no visible scalp patches).",[161,162,163],"Other types of alopecia (including, but not limited to, traction and scarring alopecia, telogen effluvium). Participants with androgenetic alopecia will be excluded.","Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc.).","Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).","Key Inclusion Criteria\n\n* 18 years or older (or the minimum age of consent in accordance with local regulations) at screening. Adolescents (12 to \\\u003C18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB\u002FEC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled\n* Have a clinical diagnosis of AA with no other etiology of hair loss.\n* Have \\>20% to \\\u003C50% hair loss of the scalp, as measured by SALT.\n* Current AA episode of hair loss ≥6 months and ≤10 years (Current episode is defined as the continuous period of AA-related scalp hair loss since the last time the subject had no visible scalp patches).\n\nKey Exclusion Criteria\n\n1\\. Diseases or conditions affecting hair loss, including:\n\n* Other types of alopecia (including, but not limited to, traction and scarring alopecia, telogen effluvium). Participants with androgenetic alopecia will be excluded.\n* Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc.).\n* Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).",[166,167,168],"CHILD","ADULT","OLDER_ADULT",[170,179,187,195],{"facility":171,"city":172,"state":173,"zip":174,"country":175,"geoPoint":176},"Dawes Fretzin Clinical Research Group, LLC","Indianapolis","Indiana","46250","United States",{"lat":177,"lon":178},39.76838,-86.15804,{"facility":180,"city":181,"state":182,"zip":183,"country":175,"geoPoint":184},"University of Iowa Hospitals & Clinics","Iowa City","Iowa","52242",{"lat":185,"lon":186},41.66113,-91.53017,{"facility":188,"city":189,"state":190,"zip":191,"country":175,"geoPoint":192},"Center for Clinical Studies - Houston - Binz Street","Houston","Texas","77004",{"lat":193,"lon":194},29.76328,-95.36327,{"facility":196,"city":189,"state":190,"zip":191,"country":175,"geoPoint":197},"Center for Clinical Studies, LTD. LLP",{"lat":193,"lon":194},[199],{"name":200,"role":201,"phone":202,"email":203},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[205],{"name":200,"affiliation":13,"role":206},"STUDY_DIRECTOR",[],[209],{"label":210,"url":211},"To obtain contact information for a study center near you, click here.","https:\u002F\u002Fpmiform.com\u002Fclinical-trial-info-request?StudyID=B7981110",{"nct_id":4,"conditions":213,"biomarkers":215},[214],"Alopecia",[],{"nct_id":4,"found":15,"summary":217,"prompt_version":227},{"design":218,"status":219,"heading":220,"summary":221,"follow_up":222,"word_count":223,"commitments":224,"compensation":225,"drugs_mentioned":226},"This is an interventional study where participants will be randomly assigned to receive ritlecitinib (50 mg or 100 mg) or a placebo. There's a 2 in 3 chance of receiving ritlecitinib 50 mg and a 1 in 3 chance of receiving placebo, and you won't know which you are getting. The study plans to enroll 336 participants.","completed","A Study of Ritlecitinib for Moderate Alopecia Areata","This study is looking into the safety and effects of ritlecitinib for people with moderate alopecia areata (patchy hair loss). You may be able to join if you are 12 years or older (with local approval) and have had patchy hair loss for 6 months to 10 years, without other hair loss conditions. Participants will receive either ritlecitinib (50 mg or 100 mg capsules) or a placebo (an inactive capsule that looks the same). The main goal is to see if ritlecitinib 50 mg helps improve hair regrowth by Week 24 compared to placebo. The study aims to enroll 336 people, but its current status is unclear.","The primary outcome is measured at Week 24, which is when the main comparison between ritlecitinib and placebo will be assessed.",107,"Not specified in the trial record.","Not stated in the trial record.",[37,34],"v2"]