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

NCT06226545 | Completed Phase 2 Results FDA Drug

• 1 other identifier: LASN01-CL-2201
• Study Type: interventional
• Target: 41
• Locations: 3 countries
• Sites: 15

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Showing a Response in Proptosis Measured Using Hertel Exophthalmometer (≥2 mm Decrease From Baseline) in the Study Eye and Separately in Either Eye Without Increased Proptosis (≥2 mm Increase) in the Other Eye

  Day 1-Day 253

• For Randomized Treatment Arms: Number of Participants With Adverse Events Receiving LASN01 Compared to Placebo

  Pooled analysis of 300 and 600 mg Q4W as compared with placebo.

  Day 1-Day 393

• For Open-label Treatment Arm: Number of Participants With Adverse Events Receiving LASN01

  Day 1-Day 393

Secondary Outcomes (1)

• Percentage of Participants Showing a Response in Clinical Activity Score (CAS) in the Study Eye Compared to Baseline as Assessed by CAS Evaluation

  Day 1-Day 253

Study Arms (4)

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

EXPERIMENTAL

Drug: LASN01

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

EXPERIMENTAL

Drug: LASN01

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

PLACEBO COMPARATOR

Drug: Placebo

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

EXPERIMENTAL

Drug: LASN01

Interventions

LASN01 DRUG

Low dose of LASN01 will be administered intravenously.

Also known as: Low-dose LASN01

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

Placebo DRUG

Placebo will be administered intravenously.

Also known as: Placebo to match

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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.
• Previous or any planned orbital irradiation/radiotherapy or orbital surgery for TED during the study period (ie, treatment and FU)
• 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)
• 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
• 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
• 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)
• Use or expected use of biotin (including multivitamins that include biotin) within 2 days before any laboratory collection

Sponsors & Collaborators

• Lassen Therapeutics Inc.: lead

Study Sites (15)

Site 111

Beverly Hills, California, 90210, United States

Location

Site 105

Palo Alto, California, 94303, United States

Location

Site 101

San Diego, California, 92093, United States

Location

Site 103

Miami, Florida, 33136, United States

Location

Site 108

Livonia, Michigan, 48152, United States

Location

Site 112

Las Vegas, Nevada, 89144, United States

Location

Site 110

Wilmington, North Carolina, 28403, United States

Location

Site 106

Houston, Texas, 77030, United States

Location

Site 104

Houston, Texas, 77401, United States

Location

Site 109

Seattle, Washington, 98104, United States

Location

Site 302

Córdoba, 14012, Spain

Location

Site 301

Seville, 41009, Spain

Location

Site 201

London, EC1V 2PD, United Kingdom

Location

Site 206

London, NW1 5QH, United Kingdom

Location

Site 204

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Graves Ophthalmopathy; Endocrine System Diseases; Orbital Diseases; Exophthalmos; Eye Diseases

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Graves Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Lassen Therapeutics

CL-2201@lassentherapeutics.com

+1-858-251-7528

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double masked treatment arms for patients without prior anti-IGF-1R treatment, and open-label treatment arm for patients with prior teprotumumab treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 26, 2024
• Study Start: March 5, 2024
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-02

Locations

GB (3); US (10); ES (2)