Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in Participants With Moderate-to-Severe Active Thyroid Eye Disease
Interventional
Phase 3
Amgen (Voir sur ClinicalTrials)
juillet 2024
septembre 2026
23 mai 2025
The study consists of a randomized double-masked, placebo-controlled, parallel-group,
multicenter trial with an optional open-label treatment period for proptosis
non-responders who complete the Double-masked Treatment Period.
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 | 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 | |||||
| AP-HM-Hôpital de La Conception - 13010 - Marseille - Bouches-du-Rhône - France | Contact (sur clinicalTrials) | ||||
| Hôpital Claude Huriez - 59000 - Lille - Nord - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Participant must provide written informed consent.
2. Participant can be male or female and must be between the ages of 18 and 80 years,
inclusive, at Screening.
3. Participant must have a clinical diagnosis of Graves' disease associated with active
TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye at
Screening and Baseline.
4. Participant must have moderate-to-severe active TED (not sight-threatening but has
an appreciable impact on daily life), usually associated with 1 or more of the
following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement and/or
inconstant or constant diplopia. (Note: Participants with no diplopia at Baseline
will be limited to approximately 25% of the total number enrolled.)
5. Participant has 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.
6. Participant had onset of active TED symptoms (as determined by participant records)
within 15 months prior to Baseline.
7. Participants must be euthyroid with the baseline disease under control or have mild
hypoor hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine
[FT3] 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.
8. Participant does not require immediate surgical ophthalmological intervention and is
not planning corrective surgery/irradiation during the trial.
9. Women of childbearing potential must have a negative serum pregnancy test at
Screening and negative urine pregnancy tests at all protocol-specified time points
(ie, prior to each dose and throughout participation in the trial).
10. Participant is willing and able to comply with the protocol requirements for the
duration of the trial.
1. Participant must provide written informed consent.
2. Participant can be male or female and must be between the ages of 18 and 80 years,
inclusive, at Screening.
3. Participant must have a clinical diagnosis of Graves' disease associated with active
TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye at
Screening and Baseline.
4. Participant must have moderate-to-severe active TED (not sight-threatening but has
an appreciable impact on daily life), usually associated with 1 or more of the
following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement and/or
inconstant or constant diplopia. (Note: Participants with no diplopia at Baseline
will be limited to approximately 25% of the total number enrolled.)
5. Participant has 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.
6. Participant had onset of active TED symptoms (as determined by participant records)
within 15 months prior to Baseline.
7. Participants must be euthyroid with the baseline disease under control or have mild
hypoor hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine
[FT3] 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.
8. Participant does not require immediate surgical ophthalmological intervention and is
not planning corrective surgery/irradiation during the trial.
9. Women of childbearing potential must have a negative serum pregnancy test at
Screening and negative urine pregnancy tests at all protocol-specified time points
(ie, prior to each dose and throughout participation in the trial).
10. Participant is willing and able to comply with the protocol requirements for the
duration of the trial.
1. Participant has decreased best-corrected visual acuity due to optic neuropathy,
defined by a decrease in vision of 2 lines on the Snellen chart (or equivalent), new
visual field defect or color defect secondary to optic nerve involvement within the
last 6 months.
2. Participant has corneal decompensation unresponsive to medical management.
3. Participant has a decrease in CAS of ≥ 2 points between Screening and Baseline.
4. Participant has a decrease in proptosis of ≥ 2 mm between Screening and Baseline.
5. Participant had prior orbital irradiation, orbital decompression or strabismus
surgery (excluding childhood strabismus surgeries unrelated to TED/Graves' disease).
6. Participant is planning to have eyelid surgery during the trial.
7. Participant received periocular botulinum toxin injection within 12 months prior to
Screening.
8. Participant has any systemic use of a steroid (IV or oral) or steroid eye drops for
the treatment of TED or other conditions within 3 weeks prior to Screening.
Exceptions include local administration (excluding periocular), eg, topical,
intra-articular, and inhaled steroids, as well as steroids used to treat infusion
reactions.