Status and phase
Conditions
Treatments
About
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, 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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion 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
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:
Surgical treatment in the study eye
Orbital radiation
Patients
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
36 participants in 4 patient groups, including a placebo group
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Central trial contact
Lassen Therapeutics
Data sourced from clinicaltrials.gov
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