Thyroid Eye DiseasePhase 2NCT06226545
A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease
A Phase 2 study testing LASN01 in people with Thyroid Eye Disease and Graves Ophthalmopathy, run by Lassen Therapeutics Inc. at 15 sites in 3 countries.
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 treatment effect, safety, and pharmacokinetics of LASN01 administered IV in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Eye Disease, Graves Ophthalmopathy, Graves Orbitopathy
- What is being tested?
- LASN01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 5 Mar 2024to 22 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States10 sites
Site 111
Beverly Hills, California, 90210
Site 106
Houston, Texas, 77030
Site 104
Houston, Texas, 77401
Site 112
Las Vegas, Nevada, 89144
Site 108
Livonia, Michigan, 48152
Site 103
Miami, Florida, 33136
Site 105
Palo Alto, California, 94303
Site 101
San Diego, California, 92093
Site 109
Seattle, Washington, 98104
Site 110
Wilmington, North Carolina, 28403
United Kingdom3 sites
Site 201
London, EC1V 2PD
Site 206
London, NW1 5QH
Site 204
Newcastle upon Tyne, NE1 4LP
About this study
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
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.
Read the 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
- Being tested
- LASN01, Placebo
- Medical subject headings
- Graves Ophthalmopathy, Endocrine System Diseases, Orbital Diseases, Exophthalmos, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASN01Drug
Also called Low-dose LASN01
Low dose of LASN01 will be administered intravenously.
LASN01Drug
Also called High-dose LASN01
High dose of LASN01 will be administered intravenously.
PlaceboDrug
Also called Placebo to match
Placebo will be administered intravenously.
LASN01Drug
Also called High-dose LASN01
High dose of LASN01 will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Randomized low-dose LASN01 (anti-IGF-1R-naïve TED) | Experimental | Not described Receives: Drug: LASN01 |
| Randomized high-dose LASN01 (anti-IGF-1R-naïve TED) | Experimental | Not described Receives: Drug: LASN01 |
| Randomized placebo (anti-IGF-1R-naïve TED) | Placebo comparator | Not described Receives: Drug: Placebo |
| Open-label high dose LASN01 (post-teprotumumab, US only) | Experimental | Not described Receives: Drug: LASN01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Day 1-Day 393
For Open-label Treatment Arm: Number of Participants With Adverse Events Receiving LASN01
Measured: 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
Measured: Day 1-Day 253
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start5 Mar 2024
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lassen Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226545
- Sponsor's protocol ID
- LASN01-CL-2201
- Status last verified
- Feb 2026
- First submitted
- 14 Dec 2023
- Last updated
- 9 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06226545
- Acronym / sponsor ID
- LASN01-CL-2201
- Conditions
- Thyroid Eye Disease, Graves Ophthalmopathy, Graves Orbitopathy, Thyroid Associated Ophthalmopathy, Endocrine System Diseases, Orbital Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Lassen Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 26 Jan 2024 (actual)
- Results
- Posted 9 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LASN01Also: Low-dose LASN01Low dose of LASN01 will be administered intravenously. | Drug | Randomized low-dose LASN01 (anti-IGF-1R-naïve TED) |
| LASN01Also: High-dose LASN01High dose of LASN01 will be administered intravenously. | Drug | Randomized high-dose LASN01 (anti-IGF-1R-naïve TED) |
| PlaceboAlso: Placebo to matchPlacebo will be administered intravenously. | Drug | Randomized placebo (anti-IGF-1R-naïve TED) |
| LASN01Also: High-dose LASN01High dose of LASN01 will be administered intravenously. | Drug | Open-label high dose LASN01 (post-teprotumumab, US only) |
Primary outcome
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
Time frame: Day 1-Day 253
For Randomized Treatment Arms: Number of Participants With Adverse Events Receiving LASN01 Compared to Placebo
Time frame: Day 1-Day 393
Pooled analysis of 300 and 600 mg Q4W as compared with placebo.
For Open-label Treatment Arm: Number of Participants With Adverse Events Receiving LASN01
Time frame: Day 1-Day 393
1 secondary outcome
Percentage of Participants Showing a Response in Clinical Activity Score (CAS) in the Study Eye Compared to Baseline as Assessed by CAS Evaluation
Time frame: Day 1-Day 253
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LASN01 in people with Thyroid Eye Disease and Graves Ophthalmopathy, run by Lassen Therapeutics Inc. at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 1-Day 253). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.