A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease
- Conditions
- Thyroid Eye DiseaseGraves OphthalmopathyGraves OrbitopathyThyroid Associated OphthalmopathyEndocrine System DiseasesOrbital DiseasesProptosisEye Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT06226545
- Lead Sponsor
- Lassen Therapeutics Inc.
- Brief Summary
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).
The primary and secondary objectives of this study are to evaluate the safety, treatment effect, 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
-
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
-
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.
-
No previous:
-
Medical treatment for TED, with the exception of:
- Local supportive measures;
- Mycophenolate, and oral or injectable steroids;
- Immunomodulating therapies
- For the open-label treatment arm only: Previous treatment with teprotumumab is required.
-
Surgical treatment in the study eye
-
Orbital radiation
-
-
Patients
- Without prior anti-IGF-1R treatment: less than 15 months from onset of TED symptoms
- With prior teprotumumab treatment: depending on time of diagnosis or reactivation of disease
- 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 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.
- Previous or any planned orbital irradiation/radiotherapy or surgery for TED during the study period (ie, treatment and FU)
- Use of oral and/or IV corticosteroid for conditions other than TED in the 6 weeks before Screening (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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Randomized placebo (anti-IGF-1R-naïve TED) Placebo - Open-label high dose LASN01 (post-teprotumumab, US only) LASN01 - Randomized low-dose LASN01 (anti-IGF-1R-naïve TED) LASN01 - Randomized high-dose LASN01 (anti-IGF-1R-naïve TED) LASN01 -
- Primary Outcome Measures
Name Time Method Changes in proptosis in the study eye compared to baseline as assessed by Exophthalmometer Day 1-Day 253 For randomized treatment arms: Number of participants with adverse events receiving LASN01 compared to placebo Day 1-Day 253 For open-label treatment arm: Number of participants with adverse events receiving LASN01 Day 1-Day 253
- Secondary Outcome Measures
Name Time Method Change in Clinical Activity Score (CAS) in the study eye compared to baseline as assessed by CAS evaluation Day 1-Day 505 Change in lid aperture in the study eye compared to baseline as measured by the changes of the distance between the lid margins Day 1-Day 505 Change in lid retraction in the study eye compared to baseline as assessed by measurement of margin reflex distance 1 and 2 Day 1-Day 505 Change in lagophthalmos in the study eye compared to baseline as assessed by presence or absence of lagophthalmos Day 1-Day 505 Change in Von Graefe's sign in the study eye compared to baseline as assessed by presence or absence of Von Graefe's sign Day 1-Day 505 Change in extraocular movements in the study eye compared to baseline as assessed by duction testing Day 1-Day 505 Change in diplopia in the study eye compared to baseline as assessed by Bahn-Gorman Scale Day 1-Day 505
Trial Locations
- Locations (16)
Site 103
🇺🇸Miami, Florida, United States
Site 108
🇺🇸Livonia, Michigan, United States
Site 112
🇺🇸Las Vegas, Nevada, United States
Site 110
🇺🇸Wilmington, North Carolina, United States
Site 106
🇺🇸Houston, Texas, United States
Site 104
🇺🇸Houston, Texas, United States
Site 109
🇺🇸Seattle, Washington, United States
Site 302
🇪🇸Córdoba, Spain
Site 303
🇪🇸Madrid, Spain
Site 301
🇪🇸Sevilla, Spain
Site 201
🇬🇧London, United Kingdom
Site 206
🇬🇧London, United Kingdom
Site 204
🇬🇧Newcastle Upon Tyne, United Kingdom
Site 111
🇺🇸Beverly Hills, California, United States
Site 105
🇺🇸Palo Alto, California, United States
Site 101
🇺🇸San Diego, California, United States