Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Thyroid Eye Disease (UplighTED)
Interventional
Phase 3
argenx (Voir sur ClinicalTrials)
mars 2024
octobre 2027
06 mai 2025
This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK),
pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with
active, moderate-to-severe TED, compared with placebo PH20 SC.
After the screening period, eligible participants will be randomized in a 2:1 ratio to
receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded
treatment period (DBTP). At the end of the DBTP, participants may enter a follow-up
observational period while off study drug. Some participants may also enter the
open-label treatment period with efgartigimod PH20 SC. The study duration varies from
approximately 60 to 110 weeks.
An alternative list of clinical sites open for recruitment could be found in the other
UplighTED study record (https://www.clinicaltrials.gov/study/NCT06307613)
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHNO DES QUINZE-VINGTS PARIS | Julia Meney, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Saint-Etienne - Hopital Nord - 42270 - Saint-Priest-en-Jarez - France | Philippe Gain, MD | Contact (sur clinicalTrials) | |||
| CHU Lille - Hopital Huriez - 59000 - Lille - France | Miriam Ladsous, MD | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon (HCL) - Hopital Louis Pradel - 69677 - Bron - France | Juliette Abeillon-Du-Payrat, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- The participant is at least 18 years of age
- The participant is capable of providing signed informed consent and following with
protocol requirements
- 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
- The participant has first onset of active TED symptoms within 12 months before
screening
- 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
- 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
- The participant is at least 18 years of age
- The participant is capable of providing signed informed consent and following with
protocol requirements
- 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
- The participant has first onset of active TED symptoms within 12 months before
screening
- 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
- 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
- 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
- Corneal decompensation (swelling of the cornea) unresponsive to medical management
- Previous orbital irradiation or surgery for TED
- Use of some medications before screening (more information is found in the protocol)
- 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
- 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
- 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
- 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
- Known hypersensitivity to study drug or one of its excipients (inactive ingredients)
- History of or current alcohol, drug, or medication abuse within 12 months before
screening as assessed by the investigator
- Pregnant or lactating state or intention to become pregnant during the study
- Live or live-attenuated vaccine received <4 weeks before screening
The complete list of exclusion criteria can be found in the protocol.