Nctid:
NCT06226545
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000005128", "term"=>"Eye Diseases"}, {"id"=>"D000049970", "term"=>"Graves Ophthalmopathy"}, {"id"=>"D000009916", "term"=>"Orbital Diseases"}, {"id"=>"D000013959", "term"=>"Thyroid Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}], "ancestors"=>[{"id"=>"D000015785", "term"=>"Eye Diseases, Hereditary"}, {"id"=>"D000006111", "term"=>"Graves Disease"}, {"id"=>"D000005094", "term"=>"Exophthalmos"}, {"id"=>"D000030342", "term"=>"Genetic Diseases, Inborn"}, {"id"=>"D000006042", "term"=>"Goiter"}, {"id"=>"D000006980", "term"=>"Hyperthyroidism"}, {"id"=>"D000001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M16718", "name"=>"Thyroid Diseases", "asFound"=>"Thyroid", "relevance"=>"HIGH"}, {"id"=>"M8271", "name"=>"Eye Diseases", "asFound"=>"Eye Disease", "relevance"=>"HIGH"}, {"id"=>"M26148", "name"=>"Graves Ophthalmopathy", "asFound"=>"Thyroid Eye Disease", "relevance"=>"HIGH"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "asFound"=>"Endocrine System Diseases", "relevance"=>"HIGH"}, {"id"=>"M12845", "name"=>"Orbital Diseases", "asFound"=>"Orbital Diseases", "relevance"=>"HIGH"}, {"id"=>"M8237", "name"=>"Exophthalmos", "relevance"=>"LOW"}, {"id"=>"M18339", "name"=>"Eye Diseases, Hereditary", "relevance"=>"LOW"}, {"id"=>"M9214", "name"=>"Graves Disease", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"M9147", "name"=>"Goiter", "relevance"=>"LOW"}, {"id"=>"M10031", "name"=>"Hyperthyroidism", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"], "maskingDescription"=>"Double masked treatment arms for patients without prior anti-IGF-1R treatment, and open-label treatment arm for patients with prior teprotumumab treatment"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>36}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-03-05", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-19", "studyFirstSubmitDate"=>"2023-12-14", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-23", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-03", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Changes in proptosis in the study eye compared to baseline as assessed by Exophthalmometer", "timeFrame"=>"Day 1-Day 197"}, {"measure"=>"For randomized treatment arms: Number of participants with adverse events receiving LASN01 compared to placebo", "timeFrame"=>"Day 1-Day 197"}, {"measure"=>"For open-label treatment arm: Number of participants with adverse events receiving LASN01", "timeFrame"=>"Day 1-Day 197"}], "secondaryOutcomes"=>[{"measure"=>"Change in Clinical Activity Score (CAS) in the study eye compared to baseline as assessed by CAS evaluation", "timeFrame"=>"Day 1-Day 421"}, {"measure"=>"Change in lid aperture in the study eye compared to baseline as measured by the changes of the distance between the lid margins", "timeFrame"=>"Day 1-Day 421"}, {"measure"=>"Change in lid retraction in the study eye compared to baseline as assessed by measurement of margin reflex distance 1 and 2", "timeFrame"=>"Day 1-Day 421"}, {"measure"=>"Change in lagophthalmos in the study eye compared to baseline as assessed by presence or absence of lagophthalmos", "timeFrame"=>"Day 1-Day 421"}, {"measure"=>"Change in Von Graefe's sign in the study eye compared to baseline as assessed by presence or absence of Von Graefe's sign", "timeFrame"=>"Day 1-Day 421"}, {"measure"=>"Change in extraocular movements in the study eye compared to baseline as assessed by duction testing", "timeFrame"=>"Day 1-Day 421"}, {"measure"=>"Change in diplopia in the study eye compared to baseline as assessed by Bahn-Gorman Scale", "timeFrame"=>"Day 1-Day 421"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Thyroid Eye Disease", "Eye Diseases", "Graves Ophthalmopathy", "Graves Orbitopathy", "Thyroid Associated Ophthalmopathy", "Endocrine System Diseases", "Orbital Diseases", "Proptosis"]}, "descriptionModule"=>{"briefSummary"=>"LASN01 is a novel, fully human antibody directed against the human IL-11 receptor being developed for treatment of patients with thyroid eye disease (TED).\n\nThe primary and secondary objectives of this study are to evaluate the safety, efficacy, and pharmacokinetics of LASN01 administered IV in patients with TED with no prior anti-IGF-1R treatment or in patients with TED who have previously received teprotumumab treatment.", "detailedDescription"=>"This clinical trial (LASN01-CL-2201) comprises a multiple-dose design in 3 parallel treatment arms for patients with TED with no prior anti-IGF-1R treatment, and a 4th treatment arm for patients with TED who have previously received teprotumumab treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Male or female patients ≥18 years of age at the time of Screening\n2. Clinical diagnosis of Graves' disease associated with active TED\n3. Moderate-to-severe active TED\n4. Female patients must be nonpregnant, nonlactating, surgically sterile for ≥6 months, or agree to use a highly effective method of contraception. Males must be surgically sterile or agree to use a highly effective method of contraception.\n5. No previous:\n\n 1. Medical treatment for TED, with the exception of:\n\n * Local supportive measures;\n * Mycophenolate, and oral or injectable steroids;\n * Immunomodulating therapies\n * For the open-label treatment arm only: Previous treatment with teprotumumab is required.\n 2. Orbital surgery\n 3. Orbital radiation\n6. Patients\n\n * Without prior anti-IGF-1R treatment: less than 15 months from onset of TED symptoms\n * With prior teprotumumab treatment: depending on time of diagnosis or reactivation of disease\n\nExclusion Criteria:\n\n1. Patients with 2 mm proptosis decrease between Screening and Day 1, or a 1-point decrease on the CAS 7-point scale between Screening and Day 1\n2. Patients with a known decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 3 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months before Screening; or any known optic neuropathy or compression or any neurologic or neuro-ophthalmologic condition that may result in visual field loss.\n3. Previous or any planned orbital irradiation/radiotherapy or orbital surgery for TED during the study period (ie, treatment and FU)\n4. Use of oral and/or IV corticosteroid for conditions other than TED in the 6 weeks before Day 1 (topical steroids for conditions other than TED are allowed)\n5. Active autoimmune disorder(s) requiring or likely to require treatment (other than Grave's disease and TED) that would interfere with study assessments, as determined by the PI or designee\n6. Any previous use of anti-IGF-1R monoclonal antibody (eg, teprotumumab) at any time, with exception to the open-label post-teprotumumab treatment arm where prior use of teprotumumab is required\n7. Use of selenium within 3 weeks before Day 1 or expected use during the clinical trial (multivitamins that include selenium are allowed in usual doses)\n8. Use or expected use of biotin (including multivitamins that include biotin) within 2 days before any laboratory collection"}, "identificationModule"=>{"nctId"=>"NCT06226545", "briefTitle"=>"A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Lassen Therapeutics Inc."}, "officialTitle"=>"A Phase 2, Proof-of-Concept, Randomized, Double-Masked, Placebo-Controlled Study to Determine the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease", "orgStudyIdInfo"=>{"id"=>"LASN01-CL-2201"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Randomized low-dose LASN01 (anti-IGF-1R-naïve TED)", "interventionNames"=>["Drug: LASN01"]}, {"type"=>"EXPERIMENTAL", "label"=>"Randomized high-dose LASN01 (anti-IGF-1R-naïve TED)", "interventionNames"=>["Drug: LASN01"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Randomized placebo (anti-IGF-1R-naïve TED)", "interventionNames"=>["Drug: Placebo"]}, {"type"=>"EXPERIMENTAL", "label"=>"Open-label high dose LASN01 (post-teprotumumab, US only)", "interventionNames"=>["Drug: LASN01"]}], "interventions"=>[{"name"=>"LASN01", "type"=>"DRUG", "otherNames"=>["Low-dose LASN01"], "description"=>"Low dose of LASN01 will be administered intravenously.", "armGroupLabels"=>["Randomized low-dose LASN01 (anti-IGF-1R-naïve TED)"]}, {"name"=>"LASN01", "type"=>"DRUG", "otherNames"=>["High-dose LASN01"], "description"=>"High dose of LASN01 will be administered intravenously.", "armGroupLabels"=>["Randomized high-dose LASN01 (anti-IGF-1R-naïve TED)"]}, {"name"=>"Placebo", "type"=>"DRUG", "otherNames"=>["Placebo to match"], "description"=>"Placebo will be administered intravenously.", "armGroupLabels"=>["Randomized placebo (anti-IGF-1R-naïve TED)"]}, {"name"=>"LASN01", "type"=>"DRUG", "otherNames"=>["High-dose LASN01"], "description"=>"High dose of LASN01 will be administered intravenously.", "armGroupLabels"=>["Open-label high dose LASN01 (post-teprotumumab, US only)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90210", "city"=>"Beverly Hills", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Site 111", "geoPoint"=>{"lat"=>34.07362, "lon"=>-118.40036}}, {"zip"=>"94303", "city"=>"Palo Alto", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Site 105", "geoPoint"=>{"lat"=>37.44188, "lon"=>-122.14302}}, {"zip"=>"92093", "city"=>"San Diego", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Site 101", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"92108", "city"=>"San Diego", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Site 102", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Site 103", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"48152", "city"=>"Livonia", "state"=>"Michigan", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Site 108", "geoPoint"=>{"lat"=>42.36837, "lon"=>-83.35271}}, {"zip"=>"89144", "city"=>"Las Vegas", "state"=>"Nevada", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Site 112", "geoPoint"=>{"lat"=>36.17497, "lon"=>-115.13722}}, {"zip"=>"28403", "city"=>"Wilmington", "state"=>"North Carolina", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Site 110", "geoPoint"=>{"lat"=>34.22573, "lon"=>-77.94471}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Site 106", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"77401", "city"=>"Houston", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Site 104", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"98104", "city"=>"Seattle", "state"=>"Washington", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Site 109", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"zip"=>"72076", "city"=>"Tübingen", "status"=>"WITHDRAWN", "country"=>"Germany", "facility"=>"Site 401", "geoPoint"=>{"lat"=>48.52266, "lon"=>9.05222}}, {"zip"=>"14012", "city"=>"Córdoba", "status"=>"RECRUITING", "country"=>"Spain", "facility"=>"Site 302", "geoPoint"=>{"lat"=>37.89155, "lon"=>-4.77275}}, {"zip"=>"28034", "city"=>"Madrid", "status"=>"RECRUITING", "country"=>"Spain", "facility"=>"Site 303", "geoPoint"=>{"lat"=>40.4165, "lon"=>-3.70256}}, {"zip"=>"41009", "city"=>"Sevilla", "status"=>"RECRUITING", "country"=>"Spain", "facility"=>"Site 301", "geoPoint"=>{"lat"=>37.38283, "lon"=>-5.97317}}, {"zip"=>"L7 8XP", "city"=>"Liverpool", "status"=>"RECRUITING", "country"=>"United Kingdom", "facility"=>"Site 203", "geoPoint"=>{"lat"=>53.41058, "lon"=>-2.97794}}, {"zip"=>"EC1V 2PD", "city"=>"London", "status"=>"RECRUITING", "country"=>"United Kingdom", "facility"=>"Site 201", "geoPoint"=>{"lat"=>51.50853, "lon"=>-0.12574}}, {"zip"=>"NW1 5QH", "city"=>"London", "status"=>"RECRUITING", "country"=>"United Kingdom", "facility"=>"Site 206", "geoPoint"=>{"lat"=>51.50853, "lon"=>-0.12574}}, {"zip"=>"SW17 0QT", "city"=>"London", "status"=>"RECRUITING", "country"=>"United Kingdom", "facility"=>"Site 202", "geoPoint"=>{"lat"=>51.50853, "lon"=>-0.12574}}, {"zip"=>"NE1 4LP", "city"=>"Newcastle Upon Tyne", "status"=>"RECRUITING", "country"=>"United Kingdom", "facility"=>"Site 204", "geoPoint"=>{"lat"=>54.97328, "lon"=>-1.61396}}], "centralContacts"=>[{"name"=>"Lassen Therapeutics", "role"=>"CONTACT", "email"=>"cl-2201@lassentherapeutics.com", "phone"=>"+1 858 251 7528"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Lassen Therapeutics Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
