NCT06226545

A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Lassen Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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.

Conditions

• Thyroid Eye Disease
• Graves Ophthalmopathy
• Graves Orbitopathy
• Thyroid Associated Ophthalmopathy
• Endocrine System Diseases
• Orbital Diseases
• Proptosis
• Eye Diseases

Interventions

Type	Name	Description
DRUG	LASN01	Low dose of LASN01 will be administered intravenously.
DRUG	LASN01	High dose of LASN01 will be administered intravenously.
DRUG	Placebo	Placebo will be administered intravenously.
DRUG	LASN01	High dose of LASN01 will be administered intravenously.

Timeline

• Start date: 2024-03-05
• Primary completion: 2025-04-22
• Completion: 2025-04-22
• First posted: 2024-01-26
• Last updated: 2026-03-09
• Results posted: 2026-03-09

Locations

15 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

• FDA-regulated drug study