Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
24
Countries
2
Sites
5
Thyroid Eye Disease
The primary objectives of this study are to evaluate the safety and efficacy of 2 dose levels of LASN01 administered IV in patients with thyroid eye disease (TED).
Key facts
- Sponsor
- Lassen Therapeutics 1 Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 28 Mar 2024 → 22 Apr 2025
- Decision date (initial)
- 2024-03-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508161-32-00
- ClinicalTrials.gov
- NCT06226545
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Pharmacodynamic, Therapy, Safety
The primary objectives of this study are to evaluate the safety and efficacy of 2 dose levels of LASN01 administered IV in patients with thyroid eye disease (TED).
Secondary objectives 1
- To assess changes in TED-related clinical parameters following IV administration of LASN01 (low or high dose) in patients with TED
Conditions and MedDRA coding
Thyroid Eye Disease
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Period After signing the ICF, patients will undergo tests to determine if they are eligible for the study. The tests done for screening may be conducted across multiple days to accommodate the patient and scheduling needs. The screening period will last up to 30 days before Day 1 of the study.
|
Not Applicable | None | ||
| 2 | Treatment Period Evaluable patients with TED will be enrolled in 3 treatment arms. Patients will be randomized centrally by IRT upon enrollment into the study, to receive LASN01 in either a high-dose or low-dose treatment arm or to a placebo. Patients will attend several clinic visits until the EOS visit.
|
Randomised Controlled | Double | [{"id":119811,"code":3,"name":"Monitor"},{"id":119813,"code":1,"name":"Subject"},{"id":119812,"code":2,"name":"Investigator"}] | Low-dose LASN01: Drug: LASN01 Low dose of LASN01 will be administered intravenously. High-dose LASN01: Drug: LASN01 High dose of LASN01 will be administered intravenously. Placebo Comparator: Placebo: Drug: Placebo Placebo will be administered intravenously. |
| 3 | Follow Up Once patients have stopped the study medication they will be asked to come to the clinic (or via telephone) to review and discuss all medications they are taking (including any changes since their last visit), as well as to discuss their general health.
|
Not Applicable | None |
Regulatory references
- Scientific advice from competent authorities
- Medicines And Healthcare Products Regulatory Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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
- Less than 15 months from day 1 of TED symptoms
- No previous: ● Medical treatment for TED, with the exception of: local supportive measures; mycophenolate, and oral or injectable steroids; immunomodulating therapies ● surgical treatment in the study eye ● any history of orbital radiation● any history of orbital surgery in the study eye
- 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.
Exclusion criteria 8
- Patients with 2 mm proptosis decrease between Screening and day 1, or a 1-point decrease on the CAS 7-point scale between during the 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 ETDRS chart (or equivalent), 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 planned orbital surgery for TED during the study period (ie, treatment and FU)
- Use of oral and/or IV corticosteroid for conditions other than TED <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
- Previous use of an anti-IGF-1R targeted treatment at any time
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Efficacy: To assess changes in proptosis in the study eye compared to baseline as assessed by Exophthalmometer
- Safety: To assess the safety and tolerability of LASN01 compared with placebo in patients with TED as assessed by changes in adverse events, concomitant medications, clinical laboratory evaluations, vital signs, ECGs, and physical examinations
Secondary endpoints 7
- Changes in TED-related clinical parameters (proptosis, CAS, lid retraction, lid aperture, lagophthalmos, Von Graefe’s sign, and diplopia) in the study eye compared to baseline
- PK parameter assessed by serum LASN01 concentration at specified timepoints for maximum plasma concentration (Cmax)
- PK parameter assessed by serum LASN01 concentration at specified timepoints for time to peak concentration (Tmax)
- PK parameter assessed by serum LASN01 concentration at specified timepoints for area under curve (AUC)
- PK parameter assessed by serum LASN01 concentration at specified timepoints for clearance volume (CL)
- PK parameter assessed by serum LASN01 concentration at specified timepoints for terminal phase volume (Vz)
- PK parameter assessed by serum LASN01 concentration at specified timepoints for half-life (t1/2)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10859839 · Product
- Active substance
- LASN01
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 7800 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- LASSEN THERAPEUTICS 1 INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Sodium Chloride 0.9% Intravenous Infusion BP
PRD382062 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID, SODIUM CHLORIDE (FOR PH ADJUSTMENT)
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 60 ml millilitre(s)
- Max total dose
- 780 ml millilitre(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- B05XX — OTHER I.V. SOLUTION ADDITIVES
- Marketing authorisation
- PL 00116/0334
- MA holder
- BAXTER HEALTHCARE LTD.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
PRD301329 · Product
- Active substance
- Water for Injection
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 7800 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- PL01502/0003R
- MA holder
- HAMELN PHARMA LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Lassen Therapeutics 1 Inc.
- Sponsor organisation
- Lassen Therapeutics 1 Inc.
- Address
- 5510 Morehouse Drive
- City
- San Diego
- Postcode
- 92121-3788
- Country
- United States
Scientific contact point
- Organisation
- Lassen Therapeutics 1 Inc.
- Contact name
- Maria Fardis
Public contact point
- Organisation
- Lassen Therapeutics 1 Inc.
- Contact name
- Maria Fardis
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 4 | 2 |
| Spain | Ended | 7 | 3 |
| Rest of world
United Kingdom, United States
|
— | 13 | — |
Investigational sites
Universitaetsklinikum Essen AöR
Ophthalmology, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Tuebingen AöR
Ophthalmology, Elfriede-Aulhorn-Strasse 7, Nordstadt, Tuebingen
Hospital Universitario Virgen De La Macarena
Ophthalmology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Ramon Y Cajal
Ophthalmology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Clinica De Oftalmologia De Cordoba S.L.
Ophthalmology, Avenida De La Arruzafa 9, 14012, Cordoba
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2024-07-09 | ||||
| Spain | 2024-03-28 | 2024-05-02 | 2024-09-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Justification for extension to submit summary of study result_21Aug2025 SUM-95136
|
2025-08-22T17:18:12 | Submitted | Summary of Results |
| LASN01-CL-2201_Full CSR SUM-119861
|
2026-02-18T11:46:36 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Justification for request for extension to submit summary of study results | 2025-08-22T17:18:23 | Submitted | Laypersons Summary of Results |
| LASN01-CL-2201 Lay summary of result | 2026-02-18T11:46:56 | Submitted | Laypersons Summary of Results |
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | LASN01-CL-2201_Laypersons Summary of Results - final_v1_12Jan2026 | 1.0 |
| Laypersons summary of results (for publication) | LASN01-CL-2201_Request for Extension to Submit Summary of Study Results_21Aug2025 | N/A |
| Protocol (for publication) | D1_Protocol_2023-508161-32-00_redacted | 7.1 |
| Recruitment arrangements (for publication) | K1 and K2_Recruitment materials and procedures_redacted | n/a |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main_redacted | 7.0.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Partner_redacted | 1.1.0 |
| Summary of results (for publication) | LASN01-CL-2201 Full CSR V1_18SEP2025_Redacted | 1.0 |
| Summary of results (for publication) | LASN01-CL-2201_Request for Extension to Submit Summary of Study Results_21Aug2025 | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_DE 2023-508161-32-00_redacted | 5.3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG 2023-508161-32-00_redacted | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES 2023-508161-32-00_redacted | 7.1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-30 | Germany | Acceptable 2024-03-01
|
2024-03-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-19 | Germany | Acceptable | 2024-04-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-30 | Germany | Acceptable 2024-07-22
|
2024-07-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-04 | Acceptable 2024-11-25
|
2024-11-29 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-12 | Acceptable 2025-03-17
|
2025-03-18 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-07 | Acceptable | 2025-04-11 |