Clinical Trials Logo

Clinical Trial Summary

The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease.


Clinical Trial Description

This is a Phase 1b, open-label, multicenter trial to assess the PK, safety, and tolerability of a single SC dose of lyophilized teprotumumab and high concentration formulation teprotumumab in participants with thyroid eye disease. Approximately 6 participants (in Cohort 1) and approximately 10 participants (in Cohort 2) who meet the trial eligibility criteria will be enrolled in a 1:1 ratio. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06389578
Study type Interventional
Source Horizon Pharma USA, Inc.
Contact
Status Completed
Phase Phase 1
Start date July 14, 2022
Completion date September 12, 2023

See also
  Status Clinical Trial Phase
Completed NCT04583735 - A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease Phase 4
Active, not recruiting NCT05002998 - TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study Phase 4
Withdrawn NCT02422368 - The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease Phase 2/Phase 3
Completed NCT03298867 - Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study Phase 3
Recruiting NCT05987423 - A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease Phase 3
Recruiting NCT06112340 - A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) Phase 2/Phase 3
Recruiting NCT05517447 - Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease Phase 3
Terminated NCT04737330 - A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED) Phase 3
Recruiting NCT05517421 - Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease Phase 3
Recruiting NCT04311606 - Anti-VEGF Therapy for Acute Thyroid Eye Disease Phase 2
Recruiting NCT06106828 - A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease (SatraGO-2) Phase 3
Recruiting NCT06021054 - A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED) Phase 3
Not yet recruiting NCT06413043 - Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy N/A
Not yet recruiting NCT06401044 - A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease Phase 1
Recruiting NCT06367517 - Tocilizumab in Corticosteroid-Resistant Graves' Orbitopathy (Thyroid Eye Disease)
Recruiting NCT06275373 - The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction
Enrolling by invitation NCT05241626 - AS-OCT of the Cornea in Thyroid Diseases
Active, not recruiting NCT05776121 - Study of ZB001 in Chinese Patients With Thyroid Eye Disease Phase 1
Recruiting NCT04359979 - Tamsulosin for Thyroid Lid Retraction N/A
Recruiting NCT06226545 - A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease Phase 2