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Leállítva2. fázis

Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis

A legfontosabb adatok

Ki végzi
ACELYRIN Inc.
Hol
Austin, Bakersfield, Bellaire, Beverly Hills, Charleston, Clearwater, Cleveland, Denver, Detroit, Erie, Hagerstown, Houston, Indianapolis, Los Angeles, Madison, Marietta, Nashville, New York, Oak Park, Palisades Park, Palo Alto, Pasadena, Phoenix, Pittsburgh, Plano, Portland, Redlands, Sacramento, San Francisco, Spokane, Waltham és Winston-Salem (Egyesült Államok)Mind a 32 helyszín megnézéseMég 6 másik országban, 23 helyszínen
Állapot
Leállítva
Fázis
2. fázis
Résztvevők
96 fő vett részt
Kezdés
2022. aug. 23.
Befejezés
2025. febr. 7.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • Izokibep
  • Placebo
A regiszteradat frissítve
2025. február 21.
Miért állt le
Study primary and secondary endpoints did not achieve statistical significance.

Ki vehet részt

Életkor
18 év – 75 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 19 feltétel megnézéseKevesebb

Ki vehet részt

  • General
  • Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
  • 18 years to 75 years of age; Type of Subject and Disease Characteristics
  • Subject is diagnosed with non-infectious intermediate-, posterior- or pan-uveitis
  • Active disease defined by the presence of at least 1 of the following criteria in at least 1 eye despite treatment with stable doses of corticosteroids for at least 2 weeks prior to day 1:; Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion by dilated indirect ophthalmoscopy, fundus photography, fluorescein angiography (FA), and Spectral-Domain Optical Coherence Tomography (SD-OCT) to determine whether a lesion is active or inactive (the central reading center assessment using FA, fundus photography and/or SD-OCT is required to confirm eligibility prior to day 1); ≥ 2+ vitreous haze (National Eye Institute [NEI]/Standardization of Uveitis Nomenclature [SUN] criteria) by digital indirect ophthalmoscope and fundus photography (the central reading center assessment using fundus photography is required to confirm eligibility prior to day 1)
  • Currently receiving treatment with oral corticosteroids (≥ 7.5 mg/day to ≤ 40 mg/day oral prednisone/prednisolone or corticosteroid equivalent) at a stable dose for at least 2 weeks prior to day 1

Ki nem vehet részt

  • Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the study
  • Subject with intraocular pressure of ≥ 25 mmHg while on ≥ 2 glaucoma medications or evidence of glaucomatous optic nerve injury
  • Subject with severe vitreous haze that precludes visualization of the fundus prior to first dose of study drug
  • Subject with best corrected visual acuity (BCVA) < 20 letters (Early Treatment Diabetic Retinopathy Study [ETDRS]) in at least 1 eye prior to first dose of study drug
  • Disease-related Medical Conditions
  • Subject with a history of active scleritis ≤ 12 months of first dose of study drug; Other protocol defined Inclusion/Exclusion criteria may apply
  • Subject with neovascular/wet age-related macular degeneration
  • Subject with isolated anterior uveitis
  • Subject with serpiginous choroidopathy
  • Subject with confirmed or suspected infectious uveitis
  • Subject has a contraindication for mydriatic eye drops OR subject cannot be dilated sufficiently well to permit good fundus visualization
  • Subject with proliferative or severe non-proliferative retinopathy or clinically significant macular edema due to diabetic retinopathy
  • Subject with an abnormality of the vitreo-retinal interface with the potential for macular structural damage independent of the inflammatory process

Helyszínek itt: Egyesült Államok

Még 6 másik országban, 23 helyszínen

  • Austin, TexasHospital not named in the registry
  • Bakersfield, CaliforniaHospital not named in the registry
  • Bellaire, TexasHospital not named in the registry
  • Beverly Hills, CaliforniaHospital not named in the registry
  • Charleston, South CarolinaHospital not named in the registry
  • Clearwater, FloridaHospital not named in the registry
  • Cleveland, OhioHospital not named in the registry
  • Denver, North CarolinaHospital not named in the registry
  • Detroit, MichiganHospital not named in the registry
  • Erie, PennsylvaniaHospital not named in the registry
  • Hagerstown, MarylandHospital not named in the registry
  • Houston, TexasHospital not named in the registry
  • Indianapolis, IndianaHospital not named in the registry
  • Los Angeles, CaliforniaHospital not named in the registry
  • Madison, WisconsinHospital not named in the registry
  • Marietta, GeorgiaHospital not named in the registry
  • Nashville, TennesseeHospital not named in the registry
  • New YorkHospital not named in the registry
  • Oak Park, IllinoisHospital not named in the registry
  • Palisades Park, New JerseyHospital not named in the registry
  • Palo Alto, CaliforniaHospital not named in the registry
  • Pasadena, CaliforniaHospital not named in the registry
  • Phoenix, ArizonaHospital not named in the registry
  • Pittsburgh, PennsylvaniaHospital not named in the registry
  • Plano, TexasHospital not named in the registry
  • Portland, OregonHospital not named in the registry
  • Redlands, CaliforniaHospital not named in the registry
  • Sacramento, CaliforniaHospital not named in the registry
  • San Francisco, CaliforniaHospital not named in the registry
  • Spokane, WashingtonHospital not named in the registry
  • Waltham, MassachusettsHospital not named in the registry
  • Winston-Salem, North CarolinaHospital not named in the registry

A vizsgálatról

Mit akar kideríteni a vizsgálat

Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin-17A, to which it binds with high affinity. This study investigates izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.

A vizsgálat 2 csoportja

  • Group 1: Placebo subcutaneous once weeklyPlacebo, összehasonlításként

    Participants will receive placebo every week to week 51.

    Kezelés: Placebo

  • Group 2: Izokibep subcutaneous once weeklyA vizsgált kezelés

    Participants will receive izokibep every week to week 51.

    Kezelés: Izokibep

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
Hivatalos cím
A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Non-infectious, Intermediate-, Posterior- or Pan-uveitis
A regiszteradat frissítve
2025. február 21.