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A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

NCT05276063 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-01-29

No results posted yet for this study

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).

Conditions

  • Thyroid Eye Disease
  • Graves Orbitopathy
  • Endocrine System Diseases
  • Eye Diseases
  • Thyroid Associated Ophthalmopathy
  • Graves Ophthalmopathy
  • Thyroid Diseases
  • Orbital Diseases
  • Proptosis
  • IGF1R
  • Exophthalmos
  • Hashimoto

Interventions

DRUG

Linsitinib

Study medication taken twice daily by mouth

DRUG

Placebo

Placebo taken twice daily by mouth

Sponsors & Collaborators

  • Sling Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-10-15
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05276063 on ClinicalTrials.gov