[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Forte Biosciences, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,66,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100639323","phase-1-a-study-testing-the-safety-and-effects-of-fb102-in-healthy-volunteers-100639323",false,"NCT07623057","A Study Testing the Safety and Effects of FB102 in Healthy Volunteers","A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity After Single and Multiple Dose Administration of FB102 Administered in Healthy Participants","Inclusion Criteria:\n\n1. Body mass index (BMI) between 18.0 and 32.0 kg\u002Fm2, inclusive, at Screening.\n2. Weight ≥50 kg and ≤100kg.\n3. Men are required to agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception for their female partner if of childbearing potential, from Screening and for at least 90 days after the EOT visit and refrain from donating sperm during this period. Effective contraception includes established use of hormonal contraception beginning at least 30 days prior to the Screening visit; or placement of an intrauterine device or intrauterine system. These contraception requirements do not apply if the male participant is in an exclusively same sex relationship; sperm donation prohibitions apply.\n4. Women are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions apply:\n\n   1. Not of childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review is acceptable).\n   2. Postmenopausal (no menses for 12 months and confirmed by follicle-stimulating hormone \\[FSH\\] level ≥40 mlU\u002FmL).\n   3. Of childbearing potential and agree to practice true abstinence or agree to use a highly effective method of contraception consistently from 30 days prior to the Screening visit until the EOT visit and are required to agree not to donate ova during the trial and for 90 days after the EOT visit.\n\nExclusion Criteria:\n\n1. Any clinically significant medical condition malignancy allergy infection or immunosuppressive condition as determined by the Investigator except cured basal or squamous cell skin cancer.\n2. Alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), and\u002For total bilirubin \\>1.5× the upper limit of normal (ULN). Participants with bilirubin \\>2× ULN that have a documented diagnosis of Gilbert's syndrome can be enrolled at the Investigator's discretion.\n3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer considered treated and cured), treated or untreated, within 5 years before Screening, regardless of whether there is no evidence of local recurrence or metastases.\n4. Positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies, or interferon-gamma release assay (IGRA) for tuberculosis.",true,"ALL","18 Years","60 Years",{"count":21,"type":22},56,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this Phase 1 trial is to evaluate the safety and effects of FB-102 in healthy volunteers following single and multiple doses.",[28],"Healthy Volunteer","NOT_YET_RECRUITING","2026-05-28",{"date":32,"type":33},"2026-06-03","ACTUAL",{"date":35,"type":22},"2026-06",{"date":37,"type":22},"2027-02",{"name":39,"class":40},"Forte Biosciences, Inc.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100608715","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-fb102-in-patients-with-severe-to-very-severe-alopecia-areata-100608715","NCT07205159","A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.","A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.","Inclusion Criteria:\n\n* Males aged 18-60 years and females aged 18-75 years at Screening.\n* Clinical diagnosis of severe to very severe AA with ≥50% scalp hair loss (including AT or AU) confirmed by SALT score and central photo review; no other cause of hair loss.\n\n  * AT = complete scalp hair loss; AU = complete scalp, facial, and body hair loss. Note: There are additional inclusion criteria. The study center will determine if participant meets all of the criteria\n\nExclusion Criteria:\n\n* Other types of alopecia (e.g., diffuse AA, traction, scarring alopecia, telogen effluvium, trichotillomania, chemotherapy-induced hair loss, androgenetic alopecia).\n* Other scalp diseases impacting AA assessment (e.g., psoriasis, dermatitis, tinea capitis).\n* Active systemic diseases causing hair loss (e.g., lupus, thyroiditis, systemic sclerosis, lichen planus, syphilis).\n\nNote: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria","75 Years",{"count":51,"type":22},32,[25],"This is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of FB102 in patients with severe to very severe alopecia areata (AA).",[55],"Alopecia Areata","RECRUITING","2025-11-17",{"date":59,"type":33},"2025-11-20",{"date":61,"type":33},"2025-10-23",{"date":63,"type":22},"2027-03-10",{"name":39,"class":40},6,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":41},"100591633","phase-2-randomized-double-blind-placebo-controlled-phase-2-study-in-adults-with-celiac-disease-100591633","NCT06982963","Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of FB102 in Adult Participants With Celiac Disease on a Gluten Free Diet","Inclusion Criteria:\n\n1. Men and women aged 18 to 70 years at Screening.\n2. Has documented diagnosis of CeD confirmed by intestinal biopsy and positive celiac serology at least 12 months prior to Screening (intestinal biopsy and serology do not have to be performed concurrently).\n3. Body mass index (BMI) between 16.0 and 40.0 kg\u002Fm2, inclusive.\n4. Self-reported to be on a GFD for at least 12 months prior to Screening and must be willing to remain on a GFD for the duration of study participation, with the exception of the oral gluten challenge administered as a study procedure. Prior acute and resolved accidental exposures are not exclusionary.\n\nExclusion Criteria:\n\n1. Uncontrolled CeD and\u002For active signs\u002Fsymptoms of CeD, in the opinion of the Investigator.\n2. History of or current neuropsychiatric manifestations specifically related to gluten exposure including ataxia, seizures, severe peripheral neuropathy, cognitive impairment, and depression.","70 Years",{"count":75,"type":22},100,[77],"PHASE2","This study is a randomized, double-blind, placebo controlled clinical study to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of FB102 in adult participants with well controlled (on a strict GFD) CeD following an oral gluten challenge.",[80],"Celiac Disease",{"date":82,"type":33},"2025-11-18",{"date":84,"type":33},"2025-08-04",{"date":86,"type":22},"2027-02-28",{"name":39,"class":40},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":65},"100585708","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-fb102-in-patients-with-non-segmental-vitiligo-100585708","NCT06905873","A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo","A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-Segmental Vitiligo","Inclusion Criteria:\n\n1. Males and females aged ≥ 18 to 75 years at time of Screening.\n2. Must have confirmed non-segmental vitiligo criteria at the Screening Visit and the Baseline Visit, as assessed by the study investigator.\n3. If receiving concomitant medications for any reason other than vitiligo, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant must be willing to stay on a stable regimen during the duration of the study.\n\nNote: There are additional inclusion criteria. The study center will determine if participant meets all of the criteria\n\nExclusion Criteria:\n\n1. Currently have active forms of other hypopigmentation (including but not limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation \\[melanoma and mycosis fungoides\\], post-inflammatory hypopigmentation, pityriasis alba \\[minor manifestation of atopic dermatitis\\], senile leukoderma \\[age-related depigmentation\\], chemical\u002Fdrug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, melasma, and congenital hypopigmentation disorders including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetrica hereditaria, xeroderma pigmentosum, and nevus depigmentosus).\n2. Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (including but not limited to morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or Day 1 Visit that in the opinion of the investigator would interfere with evaluation of vitiligo or response to treatment.\n3. Greater than approximately 33% leukotrichia (depigmentation of the hair) in areas of vitiligo on the face as assessed by a healthcare professional at the time of screening.\n\nNote: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria",{"count":96,"type":22},64,[25],"A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-Segmental Vitiligo.",[100],"Vitiligo",{"date":59,"type":33},{"date":103,"type":33},"2025-03-25",{"date":105,"type":22},"2026-12-31",{"name":39,"class":40},""]