LIDS is a clinical trial investigating an oral study drug called linsitinib to find out how well it works compared to placebo in adults with active moderate-to-severe TED. A study drug (or investigational drug) is one that is being tested in clinical research studies and not approved for use by the general public. Placebo is a drug that looks like the study drug but has no active ingredients in it.
To be eligible for this study, you must:
This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you.
Participants will be in this study for approximately 124 weeks (a little over 2 years).
After your eligibility is determined during the screening period, you will be assigned to a study drug or placebo group at the beginning of the study treatment period. During this period, you will take either the study drug linsitinib or placebo tablets by mouth twice daily. Your group assignment is done randomly (by chance; like drawing straws) by a computer. Your study group assignment is double-masked, which means you and your study doctor will not know which study group you are in or what study drug or placebo you are taking.
After you complete the 24-week study treatment period, you will either stop taking linsitinib or placebo and enter a 48-week follow-up period or if you qualify, you may choose to enroll in an extension study where all participants will receive linsitinib. The study staff will talk to you about whether you will begin the follow-up period or if you are eligible to enter the extension study. After study treatment is complete, you will be contacted two more times; once at 6 months after treatment, and once at 12 months.
Laboratory tests, physical and eye exams, and other assessments and questionnaires will be conducted as part of this study.
This study is being funded by Sling Therapeutics, Inc., who appreciates your involvement in the research study. You will receive no direct payment for taking part. However, you will be compensated for your time and reimbursed for transportation or parking payments related to visiting the study center.
The study drug will be given at no cost to you, and you will not be charged for any study doctor visits, laboratory work, tests, or procedures needed for the study.
There are possible risks involved with any clinical study. The study doctor will review the risks with participants, and participants will be closely monitored throughout the study.
A clinical study provides the basis for the development of new drugs. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic drugs and developing alternate treatment options for their disease. Current treatments for diseases like TED are only available because of research study volunteers like you.