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A Study to Evaluate the Efficacy and Safety of LASN01 in Patients with Thyroid Eye Disease
EU CTIS ID: 2023-508161-32-00
What this study is testing
The primary objectives of this study are to evaluate the safety and efficacy of 2 dose levels of LASN01 administered IV in patients with thyroid eye disease (TED).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 day 1 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 ● any history of orbital radiation● any history of orbital surgery in the study eye
- 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.
You likely can't join if
- Patients with 2 mm proptosis decrease between Screening and day 1, or a 1-point decrease on the CAS 7-point scale between during the Screening and Day 1
- 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 orbital 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 day 1 (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
See the full eligibility criteria
- 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 day 1 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 ● any history of orbital radiation● any history of orbital surgery in the study eye
- 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 day 1, or a 1-point decrease on the CAS 7-point scale between during the Screening and Day 1
- 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 orbital 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 day 1 (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 day 1 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.