Ensayos clínicos

Inclusion Criteria:

• Written informed consent.
• Male or female at least 18 years old at Screening.
• Initial diagnosis of TED ≥ 2 years but < 10 years prior to Screening. Clinical diagnosis of stable, chronic (inactive) TED, as determined by patient medical records indicating a Clinical Activity Score (CAS) ≤ 1 in both eyes for at least 1 year prior to Screening or all of the following:
  • no progression in proptosis for at least 1 year prior to Screening;
  • if patient has history of diplopia due to TED, no progression in diplopia for at least 1 year prior to Screening;
  • no new inflammatory TED symptoms for at least 1 year prior to Screening.
• CAS ≤ 1 at the Screening and Baseline Visits.
• Proptosis ≥ 3-mm increase from the patient’s baseline (prior to diagnosis of TED), as estimated by treating physician and/or proptosis ≥ 3 mm above normal for race and gender.
• Patients must be euthyroid with the patient’s baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels < 50% above or below the normal limits) 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.
• Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the trial.
• Diabetic patients must have HbA1c ≤ 8.0% at Screening.
• Patients with a history of inflammatory bowel disease, ulcerative colitis or Crohn’s disease must be in clinical remission for at least 3 months, with no history of bowel surgery within 6 months prior to screening and no planned surgery during the trial. Concomitant stable therapies for inflammatory bowel disease without modifications in the 3 months prior to Screening are allowed.
• Women of childbearing potential (including those with an onset of menopause < 2 years prior to Screening, non-therapy-induced amenorrhea for < 12 months prior to Screening, or not surgically sterile [absence of ovaries and/or uterus]) must have a negative serum pregnancy test at Screening and negative urine pregnancy tests at all protocol-specified time points (i.e., prior to each dose and throughout patient’s participation); patients who are sexually active with a non-vasectomized male partner must agree to use 2 reliable forms of contraception during the trial, 1 of which is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be started at least 1 full cycle prior to Baseline and continue for 180 days after the last dose of trial drug. Highly effective contraceptive methods (failure rate < 1% per year), when used consistently and correctly, include implants, injectables, combination oral contraceptives, some intrauterine devices, sexual abstinence and vasectomized partner.
• Male patients, if sexually active with a female partner of childbearing potential, must be surgically sterile or must agree to use a barrier contraceptive method from Screening through 180 days after the last dose of trial drug.
• Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.

Exclusion Criteria:

• Decreased best-corrected visual acuity due to optic neuropathy, defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect or color defect secondary to optic nerve involvement within the last 6 months.
• Corneal decompensation unresponsive to medical management in the study eye.
• Decrease in proptosis of ≥ 2 mm in the study eye between Screening and Baseline.
• Prior orbital irradiation, orbital decompression or strabismus surgery.
• Prior strabismus surgery.
• Alanine aminotransferase or aspartate aminotransferase > 3 × the upper limit of normal or estimated glomerular filtration rate ≤ 30 mL/min/1.73 m^2 at Screening.
• Use of any steroid (intravenous, 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.
• Any treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the first infusion of trial drug or tocilizumab (Actemra® or Roactemra®) within 6 months prior to the first infusion of trial drug. Use of any other non-steroid immunosuppressive agent within 3 months prior to the first infusion of trial drug.
• Any previous treatment with TEPEZZA, including previous enrollment in this trial or participation in a prior teprotumumab trial.
• Treatment with any monoclonal antibody within 3 months prior to Screening.
• Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude trial participation or complicate interpretation of trial results.
• Use of an investigational agent for any condition within 60 days or 5 half-lives, whichever is longer, prior to Screening or anticipated use during the course of the trial.
• Malignant condition in the past 12 months (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
• Pregnant or lactating women.
• Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the patient.
• Known hypersensitivity to any of the components of TEPEZZA or prior hypersensitivity reactions to monoclonal antibodies.

Eligibility last updated 4/20/22. Questions regarding updates should be directed to the study team contact.