A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) (LIDS)
Primary Purpose
Thyroid Eye Disease, Graves Orbitopathy, Endocrine System Diseases
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Linsitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Eye Disease focused on measuring Thyroid Associated Ophthalmopathies
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale) for the most severely affected eye (primary study eye) at Screening and Baseline
- Confirmed active TED (not sight-threatening but has an appreciable impact on daily life, with onset (as determined by patient records) within 12 months prior to the Baseline visit and usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
- Subjects must be euthyroid (defined as normal TSH) or, have subclinical hyperthyroidism (defined as normal FT4 and FT3 with TSH below the normal range).
- Does not require immediate surgery, radiotherapy or other ophthalmological intervention at the time of Screening and is not planning for any such treatment during the course of the study.
Exclusion Criteria:
- Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
- Corneal decompensation unresponsive to medical management.
- Previous orbital irradiation or surgery.
- Any steroid use (intravenous [IV] or oral) with a cumulative dose equivalent to > 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of Screening.
- Prior IGF-1R inhibitor therapy for any condition.
Sites / Locations
- Dr. Raymond Douglas Private SiteRecruiting
- UC San Diego HealthRecruiting
- Cedars-SinaiRecruiting
- UCLARecruiting
- Byers Eye Institute - Stanford UniversityRecruiting
- Bascom Palmer Eye InstituteRecruiting
- Sarasota Retina InstituteRecruiting
- Mass Eye and EarRecruiting
- Kellogg Eye CenterRecruiting
- Kahana Oculoplastic & Orbital SurgeryRecruiting
- Mayo ClinicRecruiting
- Washington University in St. Louis/Barnes Jewish HospitalRecruiting
- Columbia University
- Wake Forest Baptist Health Eye CenterRecruiting
- Oregon Health and Science UniversityRecruiting
- Neuro-Eye Clinical Trials, Inc.Recruiting
- Eyelid Center of UtahRecruiting
- West Virginia University Eye InstituteRecruiting
- University of WisconsinRecruiting
- Vancouver Coastal Health Eye Care CenterRecruiting
- Toronto Retina InstituteRecruiting
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Endocrinology Pawilione ZondaRecruiting
- AOU PisanaRecruiting
- University of PisaRecruiting
- Hospital Universitari de BellvitgeRecruiting
- Hospital La PrincesaRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- Frimley Health Foundation TrustRecruiting
- Cardiff UniversityRecruiting
- Moorfields Eye Hospital NIHR Clinical Research FacilityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Low Dose
High Dose
Arm Description
Placebo Arm
Active Arm Low Dose Linsitinib
Active Arm High Dose Linsitinib
Outcomes
Primary Outcome Measures
Percentage of Subjects who are Proptosis Responders at Week 24
Secondary Outcome Measures
Change from Baseline in Proptosis to Week 24 (Study Eye)
Percentage of Subjects who are Diplopia Responders at Week 24
Percentage of Subjects who are Overall Responders at Week 24
Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye)
Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05276063
Brief Title
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Acronym
LIDS
Official Title
A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sling Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule IGF-1R inhibitor) administered orally twice daily (BID) vs. placebo, at 24 weeks in the treatment of subjects with active, moderate to severe thyroid eye disease (TED).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease, Graves Orbitopathy, Endocrine System Diseases, Eye Diseases, Thyroid Associated Ophthalmopathy, Graves Ophthalmopathy, Thyroid Diseases, Orbital Diseases, Proptosis, IGF1R, Exophthalmos, Hashimoto
Keywords
Thyroid Associated Ophthalmopathies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Arm
Arm Title
Low Dose
Arm Type
Active Comparator
Arm Description
Active Arm Low Dose Linsitinib
Arm Title
High Dose
Arm Type
Active Comparator
Arm Description
Active Arm High Dose Linsitinib
Intervention Type
Drug
Intervention Name(s)
Linsitinib
Intervention Description
Study medication taken twice daily by mouth
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo taken twice daily by mouth
Primary Outcome Measure Information:
Title
Percentage of Subjects who are Proptosis Responders at Week 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Proptosis to Week 24 (Study Eye)
Time Frame
24 weeks
Title
Percentage of Subjects who are Diplopia Responders at Week 24
Time Frame
24 weeks
Title
Percentage of Subjects who are Overall Responders at Week 24
Time Frame
24 weeks
Title
Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye)
Time Frame
24 weeks
Title
Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale) for the most severely affected eye (primary study eye) at Screening and Baseline
Confirmed active TED (not sight-threatening but has an appreciable impact on daily life, with onset (as determined by patient records) within 12 months prior to the Baseline visit and usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
Subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine levels [FT3] < 50% above or below the normal limits) at Screening.
Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Screening and is not planning for any such treatment during the course of the study.
Exclusion Criteria:
Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
Corneal decompensation unresponsive to medical management.
Previous orbital irradiation or orbital surgery.
Any glucocorticoid use (intravenous [IV] or oral) with a cumulative dose equivalent to >= 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of Screening.
Prior IGF-1R inhibitor therapy for any condition.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathy Radovich
Phone
734-887-9192
Email
info@slingtx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Schmidt
Phone
734-887-9192
Email
info@slingtx.com
Facility Information:
Facility Name
Dr. Raymond Douglas Private Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravleen Kaur
Email
ravleen@raymonddouglasmd.com
Facility Name
UC San Diego Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iliana Molina
Email
imolina@health.ucsd.edu
Facility Name
Cedars-Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denice Dubuclet
Email
Denice.Dubuclet@cshs.org
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pearl Heumann
Email
PearlHeumann@mednet.ucla.edu
Facility Name
Byers Eye Institute - Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farheen Shaikh
Email
fqshaikh@stanford.edu
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karla Olivas
Email
kxo265@med.miami.edu
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peggy Jelemensky
Email
srqresearch@aol.com
Facility Name
Mass Eye and Ear
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Xiao-Hong
Email
Xiao-Hong_Wen@meei.harvard.edu
Facility Name
Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Green
Email
greenjw@med.umich.edu
Facility Name
Kahana Oculoplastic & Orbital Surgery
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neema Sunny
Email
neema@mioculoplastics.com
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans-Abram Voges
Email
Voges.Hans-Abram@mayo.edu
Facility Name
Washington University in St. Louis/Barnes Jewish Hospital
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jolene Brasher
Email
bjolene@wustl.edu
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marzhan Atakulova
Email
ma3448@cumc.columbia.edu
Facility Name
Wake Forest Baptist Health Eye Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Robbins
Email
cjrobbin@wakehealth.edu
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell Schain
Email
schainm@ohsu.edu
Facility Name
Neuro-Eye Clinical Trials, Inc.
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Perez
Email
lperez@neuroeye.com
Facility Name
Eyelid Center of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa Crooks
Email
acrooks@entcenterslc.com
Facility Name
West Virginia University Eye Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athena Echols
Email
athena.sparks@wvumedicine.org
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
57305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kris Dietzman
Email
kadietzman@wisc.edu
Facility Name
Vancouver Coastal Health Eye Care Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Namita Ramdin
Email
namita.ramdin@vch.ca
Facility Name
Toronto Retina Institute
City
North York
ZIP/Postal Code
M3C 0G9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myuri Jeyabalachandran
Email
mayuri.triresearch@gmail.com
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Endocrinology Pawilione Zonda
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilaria Muller
Email
ilaria.muller@policlinico.mi.it
Facility Name
AOU Pisana
City
Pisa
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanna Rotondo Dottore
Email
ge.rd@hotmail.it
Facility Name
University of Pisa
City
Pisa
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Poupak Fallahi
Email
poupak.fallahi@unipi.it
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mercè Badia
Email
mbadiav.doo@gmail.com
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Knott
Email
ck.nutricion@gmail.com
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noelia Oblanca
Email
oblanca.noelia@gmail.com
Facility Name
Frimley Health Foundation Trust
City
Camberley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Baker
Email
elizabeth.baker@nhs.net
Facility Name
Cardiff University
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Butler
Email
David.Butler2@wales.nhs.uk
Facility Name
Moorfields Eye Hospital NIHR Clinical Research Facility
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Davis
Email
amanda.davis5@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
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