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Monoclonal Antibodies

Randomized high-dose LASN01 (anti-IGF-1R-naïve TED) for Graves' Ophthalmopathy

Phase 2

Recruiting

Research Sponsored by Lassen Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Clinical diagnosis of Graves' disease associated with active TED

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1-day 169

Awards & highlights

Study Summary

This trial is testing a new antibody called LASN01 for treating thyroid eye disease. The main goals of the study are to see if LASN01 is safe and effective, and to understand how the

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, antibodies like LASN01 can cause immune reactions, infusion-related discomforts, allergic responses, and may affect how other organs function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have Graves' disease with active thyroid eye disease.

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

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My TED symptoms started less than a year ago.

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I have not had eye surgery on the eye being studied.

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I have never had radiation therapy to my eye area.

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I am a man who is either surgically sterile or willing to use effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1-day 169

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1-day 169

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1-day 169 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in proptosis in the study eye compared to baseline as assessed by Exophthalmometer

For open-label treatment arm: Number of participants with adverse events receiving LASN01

For randomized treatment arms: Number of participants with adverse events receiving LASN01 compared to placebo

Secondary outcome measures

Change in Clinical Activity Score (CAS) in the study eye compared to baseline as assessed by CAS evaluation

Change in Von Graefe's sign in the study eye compared to baseline as assessed by presence or absence of Von Graefe's sign

Change in diplopia in the study eye compared to baseline as assessed by Bahn-Gorman Scale

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Randomized low-dose LASN01 (anti-IGF-1R-naïve TED)Experimental Treatment1 Intervention

Group II: Randomized high-dose LASN01 (anti-IGF-1R-naïve TED)Experimental Treatment1 Intervention

Group III: Open-label high dose LASN01 (post-teprotumumab, US only)Experimental Treatment1 Intervention

Group IV: Randomized placebo (anti-IGF-1R-naïve TED)Placebo Group1 Intervention

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lassen Therapeutics Inc.Lead Sponsor

1 Previous Clinical Trials

80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for new participants in this ongoing clinical trial?

"Indeed, as indicated on clinicaltrials.gov, this study is currently in the process of actively recruiting eligible participants. The initial posting date for the clinical trial was January 1st, 2024, and it has been recently updated on January 23rd, 2024."

Answered by AI

What level of risk does Low-dose LASN01 pose to individuals?

"Based on our evaluation, the safety of Low-dose LASN01 is estimated to be 2 out of 3. This rating reflects the fact that this trial is in Phase 2, where there is preliminary data supporting its safety but no evidence yet regarding its efficacy."

Answered by AI

What is the total number of participants involved in this research endeavor?

"Indeed, according to the details provided on clinicaltrials.gov, this particular study is currently in search of eligible participants. The trial was initially posted on January 1st, 2024 and underwent its most recent update on January 23rd, 2024. It aims to enroll a total of 24 patients across three different sites or locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06226545.

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