LASN01-CL-2201
Research type
Research Study
Full title
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.
IRAS ID
1008264
Contact name
Bao Truong
Contact email
Sponsor organisation
Lassen Therapeutics 1, Inc.
Clinicaltrials.gov Identifier
Research summary
This clinical study is looking at (researching) a new investigational drug called LASN01. This new drug is being developed for treatment of patients with Thyroid Eye Disease (TED). The main objectives of the study are to evaluate how well the drug works (including improvement in symptoms), to learn more about potential side effects and how they can be managed and to learn what happens to LASN01 inside the body. Two dose levels of LASN01 are being looked at to determine a dose that can be taken with limited side effects while still showing signs of activity against TED (i.e., evidence of improvement of participant's symptoms). In the study the new drug is being compared to a dummy (placebo) treatment. In total we plan to recruit about 24 patients with TED into the study. Multiple hospitals in the United Kingdom and the United States may take part in the study. Each patient will participate in the study for 24 weeks. Patients will receive treatment every 4 weeks for a total of 4 doses and will be followed for an additional 12 weeks.
REC name
London - Dulwich Research Ethics Committee
REC reference
23/LO/0801
Date of REC Opinion
13 Nov 2023
REC opinion
Further Information Favourable Opinion