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Graves Ophthalmopathy clinical trials

View clinical trials related to Graves Ophthalmopathy.

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NCT ID: NCT06307626 Not yet recruiting - Thyroid Eye Disease Clinical Trials

A Study of Efgartigimod PH20 SC in Adults With Thyroid Eye Disease

Start date: March 2024
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC. After an up to 28-day screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively. Study drug will be administered subcutaneously during the 24-week double-blinded treatment period (DBTP). At the end of the DBTP (week 24), proptosis responders will enter a follow-up observational period (52 weeks) to assess the safety, tolerability, and durability of efgartigimod PH20 SC treatment while off therapy. Proptosis nonresponders and participants who have proptosis relapse during the 52-week follow-up observational period will receive open-label treatment with efgartigimod PH20 SC for up to 24 weeks.

NCT ID: NCT06307613 Not yet recruiting - Thyroid Eye Disease Clinical Trials

A Study of Efgartigimod PH20 SC in Adults With Thyroid Eye Disease

Start date: March 2024
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC. After an up to 28-day screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively. Study drug will be administered subcutaneously during the 24-week double-blinded treatment period (DBTP). At the end of the DBTP (week 24), proptosis responders will enter a follow-up observational period (52 weeks) to assess the safety, tolerability, and durability of efgartigimod PH20 SC treatment while off therapy. Proptosis nonresponders and participants who have proptosis relapse during the 52-week follow-up observational period will receive open-label treatment with efgartigimod PH20 SC for up to 24 weeks.

NCT ID: NCT06275373 Recruiting - Graves Disease Clinical Trials

The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction

Teprotumumab
Start date: May 12, 2021
Phase:
Study type: Observational

This protocol studies the clinical outcome of patients with active thyroid disease with visually significant signs and symptoms of proptosis, pain, diplopiam lid/orbital edema, or lid/orbital erythema recommended for treatment with teprotumumab infusion (Tepezza®). Patients recommended for treatment will be evaluated by an oculoplastic surgeon (Dr. Eva Chou) and endocrinologist (Dr. Thanh Hoang).

NCT ID: NCT06269393 Active, not recruiting - Clinical trials for Thyroid Associated Ophthalmopathy

A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy

Start date: January 1, 2024
Phase: Phase 3
Study type: Interventional

This is an exploratory study of the efficacy and safety of IBI311, a modified anti-IGF-1R antibody, in patients with steroid-resistant, thyroid associated ophthalmopathy (TAO). This study includes two stages. Stage I is a single-center, single-arm, open-label clinical study designed to evaluate the safety and tolerability of IBI311 in subjects with TAO. Approximately 10 subjects meeting the study eligibility criteria will be enrolled. Stage II is a single-center, randomized, double-masked, placebo-controlled clinical trial designed to evaluate the efficacy and safety of IBI311 in subjects with steroid-resistant TAO. Approximately 54 subjects meeting the study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by disease activity.

NCT ID: NCT06248619 Recruiting - Thyroid Eye Disease Clinical Trials

A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease

Start date: February 21, 2024
Phase: Phase 3
Study type: Interventional

The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.

NCT ID: NCT06235372 Not yet recruiting - Thyroid Eye Disease Clinical Trials

Evaluation of the Corneal Endothelial Cell Layer by Specular Microscopy in Patients With Thyroid Eye Disease

Start date: March 21, 2024
Phase:
Study type: Observational

To investigate corneal endothelial cell layer damage by specular microscopy in patients with thyroid eye disease

NCT ID: NCT06226545 Recruiting - Eye Diseases Clinical Trials

A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease

Start date: February 2024
Phase: Phase 2
Study type: Interventional

LASN01 is a novel, fully human antibody directed against the human IL-11 receptor being developed for treatment of patients with thyroid eye disease (TED). The primary and secondary objectives of this study are to evaluate the safety, efficacy, and pharmacokinetics of 2 dose levels of LASN01 administered IV in patients with TED.

NCT ID: NCT06179875 Recruiting - Thyroid Eye Disease Clinical Trials

An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies

Start date: February 1, 2023
Phase: Phase 3
Study type: Interventional

An open-label study for participants who are non-responders at end of the treatment period assessment (i.e., 15 weeks) in the VRND-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies

NCT ID: NCT06126783 Recruiting - Clinical trials for Thyroid Eye Disease, TED

A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Thyroid Eye Disease

Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

A multicenter, open-label extension study evaluating the efficacy and safety of IBI311 in subjects with thyroid eye disease

NCT ID: NCT06112340 Recruiting - Eye Diseases Clinical Trials

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

Start date: October 11, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.