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 - LASN01-CL-2201

assen Therapeutics 1 Inc.0 个研究点目标入组 24 人开始时间: 2023年10月30日最近更新: 2024年8月21日

适应症

试验速览

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•Male or female patients =18 years of age at the time of Screening, Clinical diagnosis of Graves’ disease associated with active TED, Moderate-to-severe active TED, Less than 15 months from onset of TED symptoms, No previous: ? Medical treatment for TED, with the exception of: local supportive measures; mycophenolate, and oral or injectable steroids; immunomodulating therapies ? surgical treatment in the study eye ? orbital radiation, 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.

•Patients with 2 mm proptosis decrease between Screening and Baseline, or a 1-point decrease on the CAS 7-point scale in any 2 weeks during the Screening period, 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 ETDRS chart (or equivalent), 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, Previous or any planned orbital irradiation/radiotherapy or planned surgery for TED during the study period (ie, treatment and FU), Use of oral and/or IV corticosteroid for conditions other than TED <6 weeks before randomization (topical steroids for conditions other than TED are allowed), 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, Previous use of an anti-IGF-1R targeted treatment at any time, Use of selenium within 3 weeks before randomization or expected use during the clinical trial (multivitamins that include selenium are allowed in usual doses), Use or expected use of biotin (including multivitamins that include biotin) within 2 days before any laboratory collection

发起方

assen Therapeutics 1 Inc.