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 treatment effect, safety, 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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
41
Site 111
Beverly Hills, California, United States
Site 105
Palo Alto, California, United States
Site 101
San Diego, California, United States
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
...and 5 more locations
Percentage of Participants Showing a Response in Proptosis Measured Using Hertel Exophthalmometer (≥2 mm Decrease From Baseline) in the Study Eye and Separately in Either Eye Without Increased Proptosis (≥2 mm Increase) in the Other Eye
Time frame: Day 1-Day 253
For Randomized Treatment Arms: Number of Participants With Adverse Events Receiving LASN01 Compared to Placebo
Pooled analysis of 300 and 600 mg Q4W as compared with placebo.
Time frame: Day 1-Day 393
For Open-label Treatment Arm: Number of Participants With Adverse Events Receiving LASN01
Time frame: Day 1-Day 393
Percentage of Participants Showing a Response in Clinical Activity Score (CAS) in the Study Eye Compared to Baseline as Assessed by CAS Evaluation
Time frame: Day 1-Day 253
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.