Study of adult participants with moderate-to-severe active thyroid eye disease
Research type
Research Study
Full title
A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in Participants with Moderate-to-Severe Active Thyroid Eye Disease.
IRAS ID
1010349
Contact name
Thomas Dykes
Contact email
Sponsor organisation
Horizon Therapeutics U.S.A., Inc.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
24/NW/0348,
Research summary
This is a Phase 3 research study to evaluate the efficacy, safety and tolerability of the study drug teprotumumab in participants with moderate-to-severe active thyroid eye disease. Approximately 80 participants will be enrolled. Participants will be randomized to receive either teprotumumab or placebo given subcutaneously (under the skin) via an investigational On-Body Injector device. Randomization is like flipping a coin; there is an equal chance of being in either treatment group. Neither the participants nor the study doctor can choose or will know which group a participant is assigned until after the study is over; this ensures that the study results are not influenced in any way. The study may last up to 56 weeks for each participant.
If participants are eligible to take part in this study, they will receive 1 subcutaneous injection of teprotumumab or placebo in the thigh or abdominal area every 2 weeks during Treatment Period 1 for a total of 12 injections. At the end of this treatment period, the study doctor will assess participants response to the study drug. If the study doctor determines participant is not responding to the study drug during Treatment period 1, participant will be given the option to participate in Treatment Period 2 where they will receive 1 subcutaneous injection of teprotumumab every 2 weeks for a total of 12 injections.
This study is being funded by Horizon Therapeutics U.S.A., Inc.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
25/YH/0065
Date of REC Opinion
10 May 2025
REC opinion
Further Information Favourable Opinion