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

NCT ID: NCT06226545

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2025-04-22

Brief 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 safety, treatment effect, 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Randomized low-dose LASN01 (anti-IGF-1R-naïve TED)

Group Type: EXPERIMENTAL

LASN01

Intervention Type: DRUG

Low dose of LASN01 will be administered intravenously.

Randomized high-dose LASN01 (anti-IGF-1R-naïve TED)

Group Type: EXPERIMENTAL

LASN01

Intervention Type: DRUG

High dose of LASN01 will be administered intravenously.

Randomized placebo (anti-IGF-1R-naïve TED)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered intravenously.

Open-label high dose LASN01 (post-teprotumumab, US only)

Group Type: EXPERIMENTAL

LASN01

Intervention Type: DRUG

High dose of LASN01 will be administered intravenously.

Interventions

LASN01

Low dose of LASN01 will be administered intravenously.

Intervention Type: DRUG

LASN01

High dose of LASN01 will be administered intravenously.

Intervention Type: DRUG

Placebo

Placebo will be administered intravenously.

Intervention Type: DRUG

LASN01

High dose of LASN01 will be administered intravenously.

Intervention Type: DRUG

Other Intervention Names

Low-dose LASN01; High-dose LASN01; Placebo to match; High-dose LASN01

Eligibility Criteria

Inclusion Criteria

1. Male or female patients ≥18 years of age at the time of Screening

2. Clinical diagnosis of Graves' disease associated with active TED

3. Moderate-to-severe active TED

4. 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.

5. No previous:

1. Medical treatment for TED, with the exception of:

• Local supportive measures;
• Mycophenolate, and oral or injectable steroids;
• Immunomodulating therapies
• For the open-label treatment arm only: Previous treatment with teprotumumab is required.

2. Orbital surgery

3. Orbital radiation

6. Patients

• Without prior anti-IGF-1R treatment: less than 15 months from onset of TED symptoms
• With prior teprotumumab treatment: depending on time of diagnosis or reactivation of disease

Exclusion Criteria

1. Patients with 2 mm proptosis decrease between Screening and Day 1, or a 1-point decrease on the CAS 7-point scale between Screening and Day 1

2. Patients with a known decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 3 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months before Screening; or any known optic neuropathy or compression or any neurologic or neuro-ophthalmologic condition that may result in visual field loss.

3. Previous or any planned orbital irradiation/radiotherapy or orbital surgery for TED during the study period (ie, treatment and FU)

4. Use of oral and/or IV corticosteroid for conditions other than TED in the 6 weeks before Day 1 (topical steroids for conditions other than TED are allowed)

5. Active autoimmune disorder(s) requiring or likely to require treatment (other than Grave's disease and TED) that would interfere with study assessments, as determined by the PI or designee

6. Any previous use of anti-IGF-1R monoclonal antibody (eg, teprotumumab) at any time, with exception to the open-label post-teprotumumab treatment arm where prior use of teprotumumab is required

7. Use of selenium within 3 weeks before Day 1 or expected use during the clinical trial (multivitamins that include selenium are allowed in usual doses)

8. Use or expected use of biotin (including multivitamins that include biotin) within 2 days before any laboratory collection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lassen Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Site 302

Córdoba, , Spain

Site 301

Seville, , Spain

Site 201

London, , United Kingdom

Site 206

London, , United Kingdom

Site 204

Newcastle upon Tyne, , United Kingdom

Countries

United States; Spain; United Kingdom

Other Identifiers

LASN01-CL-2201

Identifier Type: -

Identifier Source: org_study_id