BridgeMD
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EU CTIS ID: 2024-515090-96-00
What this study is testing
"The overall objective is to investigate the safety, tolerability and need for re-treatment of 3 different teprotumumab treatment durations in patients with Thyroid Eye Disease (TED)."
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent.
- Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- Male or female between the ages of 18 and 80 years, inclusive, at Screening.
- Initial diagnosis of TED within 7 years prior to Screening.
- Initial diagnosis of TED within 7 years prior to Screening. 4. Proptosis ≥3 mm from baseline (prior to diagnosis of TED), as estimated by treating physician, and/or proptosis >3 mm above normal for race and gender (Note: For sites in France: Normal values for proptosis do vary by gender and race [de Juan et al, 1980; Fledelius and Stubgaard, 1986; Kashkouli et al, 2008]).
- Patients must be euthyroid with the 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 duration of the trial.
You likely can't join if
- Decreased best-corrected visual acuity due to optic neuropathy, as 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.
- 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 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
- Pregnant or lactating women.
See the full eligibility criteria
Who can join
- Written informed consent.
- Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- Male or female between the ages of 18 and 80 years, inclusive, at Screening.
- Initial diagnosis of TED within 7 years prior to Screening.
- Initial diagnosis of TED within 7 years prior to Screening. 4. Proptosis ≥3 mm from baseline (prior to diagnosis of TED), as estimated by treating physician, and/or proptosis >3 mm above normal for race and gender (Note: For sites in France: Normal values for proptosis do vary by gender and race [de Juan et al, 1980; Fledelius and Stubgaard, 1986; Kashkouli et al, 2008]).
- Patients must be euthyroid with the 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 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 IBD (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 IBD 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 the patient's participation in the Follow-up Period); 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 teprotumumab. Highly effective contraceptive methods (with a failure rate <1% per year), when used consistently and correctly, include implants, injectables, bilateral tubal ligation, combination oral contraceptives, some intrauterine devices, vasectomized partner or sexual abstinence. Abstinence should only be used as a contraceptive method if it is in line with the patient's usual and preferred lifestyle and periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not an acceptable method of contraception. Periodic abstinence, withdrawal (coitus interruptus) or spermicides only are not acceptable methods of contraception. For sites in France, highly effective contraceptive methods (with a failure rate <1% per year), when used consistently and correctly, include: • combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral intravaginal transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation: oral injectable implantable • intrauterine device (IUD) • intrauterine hormone-releasing system (IUS) • bilateral tubal ligation • vasectomized partner • sexual abstinence (Abstinence should only be used as a contraceptive method if it is in line with the patient's usual and preferred lifestyle; periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] is not an acceptable method of contraception.)
What rules you out
- Decreased best-corrected visual acuity due to optic neuropathy, as 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.
- 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 5 years (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 teprotumumab or prior hypersensitivity reactions to monoclonal antibodies.
- Human immunodeficiency virus, untreated or positive viral load for hepatitis C or hepatitis B infections
- Any other condition that, in the opinion of the Investigator, would preclude inclusion in the trial.
- After 150 patients with a CAS <3 at Baseline have been randomized, an additional exclusion criterion will apply: CAS <3 at Baseline.
- Corneal decompensation unresponsive to medical management.
- Decrease in proptosis of ≥2 mm in the study eye between Screening and Baseline
- Prior orbital irradiation, orbital decompression or strabismus surgery.
- Planned eyelid surgery during the course of the trial.
- Alanine aminotransferase or aspartate aminotransferase >3 × the upper limit of normal or estimated glomerular filtration rate ≤30 mL/min/1.73m2 at Screening.
- Any systemic use of any steroid (intravenous [IV] or oral), or steroid eye drops for the treatment of TED or other conditions within 3 weeks prior to Screening. Such steroids cannot be initiated during the trial. Exceptions include local administration [excluding steroid eye drops], eg, topical (for skin only), intraarticular, and inhaled steroids, as well as allowance for systemic steroids (IV or oral) used to treat infusion reactions.
- Any treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the first infusion of teprotumumab or tocilizumab (Actemra® or Roactemra®) within 6 months prior to the first infusion of teprotumumab. Use of any other non-steroid immunosuppressive agent within 3 months prior to the first infusion of teprotumumab.
- Any previous treatment with teprotumumab, including previous enrollment in this trial or participation in a prior teprotumumab trial.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.