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A study of efgartigimod PH20 SC given by prefilled syringe in adults with thyroid eye disease
EU CTIS ID: 2023-509197-35-00
What this study is testing
To evaluate the efficacy of efgartigimod PH20 SC compared with placebo PH20 SC at week 24 of the Double Blind treatment period (DBTP) on the proptosis responder rate.
- Therapeutic confirmatory (Phase III)
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
- 1. The participant is at least 18 years of age
- 2. The participant is capable of providing signed informed consent and following with protocol requirements.
- 3C. The investigator determines active, moderate-to-severe thyroid eye disease (TED) associated with autoimmune thyroid conditions (Graves’ disease or Hashimoto’s thyroiditis) for the most severely affected eye.
- 4A. The participant has first onset of active TED symptoms within 12 months before screening.
- 5. The participant must have normal thyroid function with the 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 normal thyroid function for the full duration of the study
- 6. The participant agrees to use birth control consistent with local regulations and the people of child-bearing potential must have a negative blood pregnancy test at screening and a negative urine pregnancy test before receiving the study drug
You likely can't join if
- 1. Optic neuropathy (damage to optic nerve), defined as new visual field defect (blind spot), relative afferent pupillary defect (pupils respond differently to light), or color defect secondary to optic nerve involvement within the 6 months before screening
- 10. History of or current alcohol, drug, or medication abuse within 12 months before screening as assessed by the investigator.
- 11. Pregnant or lactating state or intention to become pregnant during the study
- 12. Live or live-attenuated vaccine received <4 weeks before screening
- 2. Corneal decompensation (swelling of the cornea) unresponsive to medical management
- 3. Previous orbital irradiation or surgery for TED
See the full eligibility criteria
- 1. The participant is at least 18 years of age
- 2. The participant is capable of providing signed informed consent and following with protocol requirements.
- 3C. The investigator determines active, moderate-to-severe thyroid eye disease (TED) associated with autoimmune thyroid conditions (Graves’ disease or Hashimoto’s thyroiditis) for the most severely affected eye.
- 4A. The participant has first onset of active TED symptoms within 12 months before screening.
- 5. The participant must have normal thyroid function with the 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 normal thyroid function for the full duration of the study
- 6. The participant agrees to use birth control consistent with local regulations and the people of child-bearing potential must have a negative blood pregnancy test at screening and a negative urine pregnancy test before receiving the study drug
- 1. Optic neuropathy (damage to optic nerve), defined as new visual field defect (blind spot), relative afferent pupillary defect (pupils respond differently to light), or color defect secondary to optic nerve involvement within the 6 months before screening
- 10. History of or current alcohol, drug, or medication abuse within 12 months before screening as assessed by the investigator.
- 11. Pregnant or lactating state or intention to become pregnant during the study
- 12. Live or live-attenuated vaccine received <4 weeks before screening
- 2. Corneal decompensation (swelling of the cornea) unresponsive to medical management
- 3. Previous orbital irradiation or surgery for TED
- 4. Use of some medications before screening (more information is found in the protocol)
- 5. Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of TED or puts the participant at undue risk
- 6. History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer.
- 7. Clinically significant active infection that is not sufficiently resolved in the investigator’s opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV) , Hepatitis C virus (HCV) , HIV
- 8. Current participation in another interventional clinical study or previous participation in an efgartigimod clinical study and at least 1 dose of study drug received or has received at least 1 dose of commercially available efgartigimod
- 9. Known hypersensitivity to study drug or one of its excipients (inactive ingredients)
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Singapore
- Korea, Republic of
- Thailand
- China
- Australia
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Singapore; Korea, Republic of; Thailand; China and 1 more location(s). 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.