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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 December 2021 |
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Main ID: |
NCT03461211 |
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Date of registration:
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05/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Multicenter, Safety and Efficacy, Open-Label Extension Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Thyroid Eye Disease
OPTIC-X |
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Scientific title:
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Multicenter, Safety and Efficacy, Open-Label Extension Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Thyroid Eye Disease |
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Date of first enrolment:
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April 16, 2018 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03461211 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Italy
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United States
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Contacts
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Name:
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Raymond Douglas, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cedars-Sinai Medical Center |
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Name:
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George Kahaly, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johannes Gutenberg University Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent.
- Completed the 24-week double-masked Treatment Period in Study HZNP-TEP-301
(NCT03298867).
- Proptosis non-responder (< 2 mm reduction in proptosis in the study eye) at Week 24 of
Study HZNP-TEP-301 OR proptosis responder at Week 24 who relapses during the Follow-Up
Period of Study HZNP-TEP-301.
- Participant must be euthyroid with the baseline disease under control, or have mild
hypo- or hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine
[FT3] levels < 50% above or below the normal limits) at the most recent clinic visit.
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 clinical trial.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =3 times the upper
limit of normal (ULN) or serum creatinine <1.5 times the upper limit of normal (ULN;
according to age) at the most recent clinic visit.
- Diabetic participants must have well-controlled disease (defined as hemoglobin A1C
[HbA1c] < 9.0% at most recent clinic visit).
- Does not require immediate surgical ophthalmological intervention and is not planning
corrective surgery/irradiation during the course of the study.
- Women of childbearing potential must have a negative urine pregnancy test at
Baseline/Day 1. Participants who are sexually active with a non-vasectomized male
partner must agree to use 2 reliable forms of contraception during the trial and
continue for 180 days after the last dose of study drug. One of the 2 forms of
contraception is recommended to be hormonal, such as an oral contraceptive. Hormonal
contraception must be in use for at least one full cycle prior to Baseline. Highly
effective contraceptive methods (with a failure rate less than 1% per year), when used
consistently and correctly, includes implants, injectables, combined oral
contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised
partner.
- Male participants must be surgically sterile or, if sexually active with a female
partner of childbearing potential, must agree to use a barrier contraceptive method
from Baseline through 180 days after the last dose of study drug.
- Participant is willing and able to comply with the prescribed treatment protocol and
evaluations for the duration of the study.
- Has not received any treatment for TED since Week 24 of the of the HZNP-TEP-301 study.
Exclusion Criteria:
- Participants will be ineligible if, in the opinion of the Investigator, they are
unlikely to comply with the study protocol or have a concomitant disease or condition
that could interfere with the conduct of the study or potentially put the participant
at unacceptable risk.
- The exclusion criteria (except those related to screening) of protocol
HZNP-TEP-301(NCT03298867) also apply to this open-label extension study.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Thyroid Eye Disease
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Intervention(s)
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Biological: Teprotumumab
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Primary Outcome(s)
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Percentage of Participants With a = 2 mm Reduction From Baseline in the Study Eye Without Deterioration of Proptosis in the Fellow Eye at Week 24
[Time Frame: Baseline, Week 24]
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Secondary Outcome(s)
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Percentage of Participants With a European Group on Graves' Ophthalmopathy (EUGOGO) Amended Clinical Activity Score (CAS) Total Score of 0 or 1 in the Study Eye at Week 24
[Time Frame: Week 24]
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Percentage of Participants Who Were Diplopia Responders at Week 24
[Time Frame: Week 24]
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Change in Proptosis From Baseline to Week 24
[Time Frame: Study Baseline, Week 24]
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Mean Change From Baseline to Week 24 in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score
[Time Frame: Study Baseline, Week 24]
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Secondary ID(s)
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2017-002713-58
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HZNP-TEP-302
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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