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

Eye Diseases Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226545
• Other study ID #: LASN01-CL-2201
• Status: Recruiting
• Phase: Phase 2
• Start date: March 5, 2024
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Lassen Therapeutics Inc.
• Contact: Lassen Therapeutics
• Phone: +1 858 251 7528
• Email: cl-2201[@]lassentherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, efficacy, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Surgical treatment in the study eye

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 Baseline, or a 1-point decrease on the CAS 7-point scale in any 2 weeks during the Screening period

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 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 Screening (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 randomization 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• LASN01
Low dose of LASN01 will be administered intravenously.
• LASN01
High dose of LASN01 will be administered intravenously.
• Placebo
Placebo will be administered intravenously.
• LASN01
High dose of LASN01 will be administered intravenously.

Locations

Country	Name	City	State
Spain	Site 302	Córdoba
United Kingdom	Site 203	Liverpool
United Kingdom	Site 201	London
United Kingdom	Site 202	London
United Kingdom	Site 206	London
United Kingdom	Site 204	Newcastle Upon Tyne
United States	Site 104	Houston	Texas
United States	Site 108	Livonia	Michigan
United States	Site 101	San Diego	California
United States	Site 102	San Diego	California
United States	Site 109	Seattle	Washington
United States	Site 110	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Lassen Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in proptosis in the study eye compared to baseline as assessed by Exophthalmometer		Day 1-Day 113
Primary	For randomized treatment arms: Number of participants with adverse events receiving LASN01 compared to placebo		Day 1-Day 169
Primary	For open-label treatment arm: Number of participants with adverse events receiving LASN01		Day 1-Day 169
Secondary	Change in Clinical Activity Score (CAS) in the study eye compared to baseline as assessed by CAS evaluation		Day 1-Day 169
Secondary	Change in lid aperture in the study eye compared to baseline as measured by the changes of the distance between the lid margins		Day 1-Day 169
Secondary	Change in lid retraction in the study eye compared to baseline as assessed by measurement of margin reflex distance 1 and 2		Day 1-Day 169
Secondary	Change in lagophthalmos in the study eye compared to baseline as assessed by presence or absence of lagophthalmos		Day 1-Day 169
Secondary	Change in Von Graefe's sign in the study eye compared to baseline as assessed by presence or absence of Von Graefe's sign		Day 1-Day 169
Secondary	Change in extraocular movements in the study eye compared to baseline as assessed by duction testing		Day 1-Day 169
Secondary	Change in diplopia in the study eye compared to baseline as assessed by Bahn-Gorman Scale		Day 1-Day 169