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Teprotumumab for Thyroid Eye Disease
Study Summary
This trial is studying the safety and effectiveness of a new drug, teprotumumab, in the treatment of Thyroid Eye Disease. The trial is international, Phase 3b/4, and will last for different lengths of time depending on the participant.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My eye bulging has increased by 3 mm or more since my TED diagnosis.You are allergic to teprotumumab or have had allergic reactions to similar medications in the past.You have untreated HIV, or positive viral load for hepatitis C or hepatitis B infections.I was diagnosed with TED within the last 7 years.I have had radiation, surgery to relieve eye pressure, or eye muscle surgery.I haven't taken rituximab, tocilizumab, or non-steroid immunosuppressants recently.My thyroid function is normal or slightly off but under control.The eye that will be studied must not have decreased in size by 2 millimeters or more between the initial screening and the start of the study.You have any other health issue that would prevent you from joining the trial.I don't need eye surgery now or during the trial.My liver enzymes are high or my kidney function is low.I haven't taken any steroids for TED or other conditions in the last 3 weeks.I have never been treated with teprotumumab or participated in any teprotumumab trials.I am not pregnant and agree to use two reliable birth control methods if I can have children.My IBD has been in remission for 3+ months, no recent bowel surgery, and my IBD treatment hasn't changed recently.I haven't had cancer in the last 5 years, except for certain skin or cervical cancers.I do not have any eye conditions that could affect the trial.I haven't received monoclonal antibody therapy in the last 3 months.I am scheduled for eyelid surgery during the trial.My vision has worsened in the last 6 months due to optic nerve damage.I am between 18 and 80 years old.If you have diabetes, your HbA1c level must be 8.0% or lower when you are screened for the study.My eye condition has not improved with medication.
- Group 1: Teprotumumab 4 Infusions
- Group 2: Teprotumumab 16 Infusions
- Group 3: Teprotumumab 8 Infusions
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many volunteers are currently enrolled in this medical experiment?
"This clinical trial requires 300 suitable participants, who meet the outlined inclusionary criteria. Eligible individuals can register from Bascom Palmer Eye Institute in Miami or Washington University in St Louis."
Could you provide details on the security measures of this treatment for participants?
"Accruing to our safety rating system, this treatment is assigned a score of 3 due to its approval status as a Phase 4 trial."
Are investigators currently inviting participants to join this research endeavor?
"According to clinicaltrials.gov, this research is seeking participants. The trial was initially published on September 16th 2021 and its details were last modified a year later on the same day."
What is the current scope of this clinical trial's implementation?
"Participants for this trial can be recruited from 7 different sites, such as the Bascom Palmer Eye Institute in Miami and Washington University in St. Louis among other medical centres."
Does this clinical experiment accept elderly participants?
"Prospective participants of this research must be aged between 18 and 80 years old."
Is it possible for me to take part in this experiment?
"This medical study seeks 300 individuals, aged 18-80 with an ocular disorder. Participants must not need immediate surgical intervention and should have their condition managed or mild hypo/hyperthyroidism (with serum TSH levels up to 50% above or below normal). Those who have a history of IBD should be in remission for at least 3 months without surgery 6 months prior to screening. They must also adhere to the protocol's requirements and evaluations throughout the trial period."
Are there any previously conducted studies regarding this treatment method?
"Currently, 3 medical trials related to this therapy are underway with no Phase 3 studies in progress. These experiments primarily occur in Toledo, OH yet 45 different research sites across the country are testing its efficacy."
Is this an experimental endeavor?
"At present, Horizon Therapeutics USA, Inc. has 3 running trails of this medication active across 27 cities and 6 countries. The original study was conducted in 2021 with 62 participants and completed Phase 4 drug approval stages; since then a total of 18336 trials have taken place."
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