Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
Purpose
The goal of this clinical trial is to evaluate the efficacy, safety, and tolerability of linsitinib in participants with moderate to severe Thyroid Eye Disease (TED).
Conditions
- Thyroid Eye Disease, TED
- Graves Orbitopathy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants must be ≥ 18 years of age at Screening 2. Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye (primary study eye) at Screening and Baseline. 3. Moderate to severe active TED (not sight-threatening but has an appreciable impact on daily life), with diagnosis of TED within 15 months prior to the Screening visit and usually associated with 1 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia. 4. Participants 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 of the central laboratory) at Screening. 5. 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
- Any progressing optic neuropathy due to TED that has worsened in the last 6 months in the opinion of the investigator. 2. Corneal decompensation unresponsive to medical management. 3. Previous orbital irradiation or orbital surgery in either eye. 4. Any glucocorticoid use (IV or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone or equivalent for the treatment of TED within 8 weeks of Screening. 5. Prior IGF-1R inhibitor therapy for any condition.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Double-mask Treatment Arm |
Participants receive linsitinib 150 mg twice daily for 24 weeks. |
|
|
Placebo Comparator Double-mask Placebo Arm |
Participants receive placebo 0 mg twice daily for 24 weeks. |
|
|
Experimental Open-label Extension Treatment Arm |
Proptosis non-responders/relapsed proptosis responders receive linsitinib 150 mg twice daily for 24 weeks. |
|
Recruiting Locations
Advancing Research International
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
More Details
- Status
- Recruiting
- Sponsor
- Sling Therapeutics, Inc.