LASN01 for Thyroid Eye Disease

Recruiting at18 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Lassen Therapeutics Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing LASN01, a human protein-based medicine, in patients with thyroid eye disease. It aims to help those who haven't had certain treatments before and those who have already tried teprotumumab. The medicine works by blocking part of the immune system to reduce eye problems.

Research Team

Eligibility Criteria

This trial is for patients with Thyroid Eye Disease (TED), a condition often associated with Graves' disease, causing eye problems like bulging eyes. Participants should have active symptoms and be suitable for intravenous treatment.

Inclusion Criteria

I am 18 years old or older.

I have Graves' disease with active thyroid eye disease.

I have moderate-to-severe active thyroid eye disease.

Exclusion Criteria

I have experienced significant vision loss or changes due to optic nerve issues in the last 6 months.

I haven't taken oral or IV steroids for non-TED conditions in the last 6 weeks.

I have used anti-IGF-1R monoclonal antibody treatment before.

Treatment Details

Interventions

• LASN01 (Monoclonal Antibodies)

Trial Overview The study tests LASN01, an antibody targeting the IL-11 receptor, which could help treat TED. Patients will receive one of two different doses of LASN01 or a placebo through IV to compare safety and effectiveness.

Participant Groups

Group I: Randomized low-dose LASN01 (anti-IGF-1R-naïve TED) Experimental Treatment 1 Intervention

Group II: Randomized high-dose LASN01 (anti-IGF-1R-naïve TED) Experimental Treatment 1 Intervention

Group III: Open-label high dose LASN01 (post-teprotumumab, US only) Experimental Treatment 1 Intervention

Group IV: Randomized placebo (anti-IGF-1R-naïve TED) Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Lassen Therapeutics Inc.

Lead Sponsor

Trials

2

Recruited

120+