A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease

NCT ID: NCT06389578

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-14
• Study Completion Date: 2023-09-12

Brief 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.

Detailed 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 acquired from Horizon in 2024.

Conditions

Thyroid Eye Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Participants will receive a single dose of lyophilized teprotumumab by subcutaneous (SC) administration on Day 1 followed by intravenous (IV) infusions of teprotumumab at the approved dosing regimen.

Group Type: EXPERIMENTAL

Teprotumumab

Intervention Type: DRUG

SC administration and IV infusion

Cohort 2

Participants will receive a single high concentration formulation teprotumumab by SC administration on Day 1 followed by IV infusions of teprotumumab at the approved dosing regimen.

Group Type: EXPERIMENTAL

Teprotumumab

Intervention Type: DRUG

SC administration and IV infusion

Interventions

Teprotumumab

SC administration and IV infusion

Intervention Type: DRUG

Other Intervention Names

Tepezza

Eligibility Criteria

Inclusion Criteria

1. Thyroid eye disease (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis, and/or inconstant or constant diplopia.

2. Proptosis ≥ 3 mm increase from the participant's baseline (prior to diagnosis of TED), as estimated by treating physician and/or proptosis ≥ 3 mm above normal for race and gender.

3. Participant must be euthyroid with baseline disease under control or have mild hypo- or hyperthyroidism at Screening. Every effort should be made to correct the mild hypo or hyperthyroidism promptly and to maintain the euthyroid state for the full duration of the trial.

4. Does not require immediate surgical ophthalmological intervention.

5. Participants with diabetes must have HbA1c ≤ 8.0% at Screening.

Exclusion Criteria

1. Decreased best-corrected visual acuity due to optic neuropathy within the last 6 months.

2. Corneal decompensation unresponsive to medical management in the study eye.

3. Decrease in proptosis of ≥ 2 mm in the study eye between Screening and Baseline.

4. Alanine aminotransferase or aspartate aminotransferase > 3x the upper limit of normal or estimated glomerular filtration rate ≤ 30 mL/min/1.73 m2 at Screening.

5. Use of any steroid (IV, oral, steroid eye drops) for the treatment of TED or other conditions within 3 weeks prior to Screening. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids and steroids used to treat infusion reactions.

6. Any treatment with rituximab, tocilizumab, or any other non-steroid immunosuppressive agent within 90 days prior to the first injection of investigational product on Day 1.

7. Any previous treatment with HZN-001 or TEPEZZA (teprotumumab-trbw), including previous enrollment in this trial or participation in a prior TEPEZZA trial.

8. Treatment with any mAb within 3 months prior to Screening.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Bascom Palmer Eye Institute - University of Miami

Miami, Florida, United States

Barnes Jewish Hospital Washington University

St Louis, Missouri, United States

Neuro-Eye Clinical Trials

Bellaire, Texas, United States

Countries

United States

Other Identifiers

HZNP-TEP-103

Identifier Type: -

Identifier Source: org_study_id