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

Lassen Therapeutics

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Placebo; Drug: LASN01

Study type: Interventional

Funder types: Industry

Identifiers

NCT06226545

LASN01-CL-2201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

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

Experimental group

Treatment:

Drug: LASN01

Drug: LASN01

Drug: LASN01

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

Experimental group

Treatment:

Drug: LASN01

Drug: LASN01

Drug: LASN01

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

Placebo Comparator group

Treatment:

Drug: Placebo

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

Experimental group

Treatment:

Drug: LASN01

Drug: LASN01

Drug: LASN01