Résztvevőt keres itt: Kanada2. fázis

A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease

A legfontosabb adatok

Ki végzi: Sanofi
Hol: Calgary, Sherbrooke és Surrey (Kanada)Mind a 3 helyszín megnézéseMég 8 másik országban, 21 helyszínen
Azonosító: NCT06984627
EudraCT 2025-521023-75
U1111-1316-0208
Állapot: Toboroz
Fázis: 2. fázis
Résztvevők: 30 fő, tervezett
Kezdés: 2025. szept. 2.
Várható befejezés: 2027. márc. 11.
A vizsgálat típusa: Beavatkozással járó, 2 csoport
A vizsgált kezelések: Rilzabrutinib dose 1
Rilzabrutinib dose 2
A regiszteradat frissítve: 2026. október 28.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with Graves' disease and an overactive thyroid, with or without active Graves' eye disease (Graves' orbitopathy).

Életkor: 18 Years to 75 Years
Nem: All sexes can join.
A betegség stádiuma: Confirmed Graves' disease with active hyperthyroidism (overactive thyroid). Some people will also have active Graves' orbitopathy: a clinical activity score (CAS) ≥3 in the worse eye, plus one or more of: lid retraction ≥2 mm, moderate or severe soft tissue involvement, proptosis (bulging eye) ≥2 mm, or double vision that comes and goes or is constant.

A részvétel fő kizáró okai

Overactive thyroid caused by something other than Graves' disease, such as toxic multinodular goiter or a thyroid nodule.
Past thyroid storm, or high risk of it.
Large goiter blocking the airway or needing surgery during the study.
Eye disease that threatens sight, needs urgent eye surgery, or reduced vision from optic nerve damage in the last 6 months.
Graves' orbitopathy symptoms that started >9 months before the study start.

A regiszter feltételei, szó szerint

Mind a 10 feltétel megnézéseKevesebb

Ki vehet részt

Participants who have a confirmed diagnosis of Graves' disease with active hyperthyroidism, with or without active Graves' orbitopathy at the time of screening
A subset of participants will have a diagnosis of active Graves' orbitopathy, as confirmed by ophthalmic exam at screening and a clinical activity score (CAS) ≥3 for the most severely affected eye, and associated with one or more of the following: lid retraction ≥2 mm, moderate or severe soft tissue involvement, proptosis ≥2 mm, and/or intermittent or constant diplopia
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Ki nem vehet részt

Enlarged thyroid goiter causing upper airway obstruction and/or requiring surgical intervention during the study period
For participant with Graves' orbitopathy, requires immediate surgical ophthalmological intervention or is planning corrective surgery/irradiation during the course of the study
Onset of Graves' orbitopathy symptoms >9 months prior to baseline; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
History of hyperthyroidism not caused by Graves' disease (eg, hyperthyroidism due to toxic multinodular goiter, autonomous thyroid nodule, acute inflammatory thyroiditis)
History of thyroid storm or at high risk of developing thyroid storm as determined by evaluating clinician
Sight threatening Graves' orbitopathy or decreased visual acuity due to optic neuropathy within the last 6 months
Corneal decompensation unresponsive to medical management

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

18 és 75 év között vagy?

Helyszínek itt: Kanada

Még 8 másik országban, 21 helyszínen

Calgary, AlbertaHospital not named in the registryRésztvevőt keres
Sherbrooke, QuebecHospital not named in the registryRésztvevőt keres
Surrey, British ColumbiaHospital not named in the registryRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

This is a parallel group, Phase 2, 2-arm study to measure the treatment effect and safety of rilzabrutinib dose 1 or rilzabrutinib dose 2 in participants with Graves' disease, with and without Graves' orbitopathy, aged 18 years or older.

A teljes eredeti leírásKevesebb

Study details include:

* Screening period (up to 4 weeks). * Treatment period (up to 16 weeks). * Follow-up period (4 weeks). The number of visits will be up to 13.