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Befejeződött2. fázis

PRV-015 in Gluten-free Diet Non-responsive Celiac Disease

A legfontosabb adatok

Ki végzi
Provention Bio, a Sanofi Company
Hol
Bellevue, Boston, Brooklyn, Cedar Park, Chesterfield, Chevy Chase, Chicago, Denver, Dublin, Garland, Leesburg, Los Angeles, Morristown, Nashville, New Windsor, New York, North Charleston, Northbrook, Philadelphia, Raleigh, Rochester, Tacoma, Tampa, Uniontown, Ventura, Warwick, West Jordan és Winter Park (Egyesült Államok)Mind a 28 helyszín megnézéseMég 3 másik országban, 8 helyszínen
Állapot
Befejeződött
Fázis
2. fázis
Résztvevők
388 fő vett részt
Kezdés
2020. aug. 24.
Befejezés
2024. júl. 30.
A vizsgálat típusa
Beavatkozással járó, 4 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • PRV-015
  • Placebo
A regiszteradat frissítve
2025. október 20.

Ki vehet részt

Életkor
18 év – 70 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 14 feltétel megnézéseKevesebb

Ki vehet részt

  • A diagnosis of celiac disease by intestinal biopsy
  • Following a GFD for at least 12 consecutive months
  • Must have detectable (above the lower limit of detection) serum celiac-related antibodies
  • Must have human leukocyte antigen DQ (HLA-DQ) typing consistent with celiac disease (DQ2 and/or DQ8)
  • Subjects must have had at least one of the following symptoms at least once per week during the month before screening: diarrhea, loose stools, abdominal pain, abdominal cramping, bloating, or gas
  • Body weight between 35 and 120 kg

Ki nem vehet részt

  • Known or suspected exposure to coronavirus disease 2019 (COVID-19) infection in the 4 weeks before screening
  • Administration of a live vaccine within 14 days prior to randomization and the first administration of study drug
  • Current diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 (RCD-I) or RCD-II, enteropathy-associated T-cell lymphoma (EATL), ulcerative jejunitis, or gastrointestinal (GI) perforation
  • Diagnosis of any chronic, active GI disease other than celiac disease
  • Presence of any active infection
  • History or presence of any clinically significant disease that, in the opinion of the Investigator, may confound the subject's participation and follow-up in the clinical trial or put the subject at unnecessary risk
  • Selective immunoglobulin A (IgA) deficiency, defined as having undetectable levels of IgA
  • Females who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding

Helyszínek itt: Egyesült Államok

Még 3 másik országban, 8 helyszínen

  • Bellevue, WashingtonHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital not named in the registryNo longer taking part
  • Brooklyn, New YorkHospital not named in the registryNo longer taking part
  • Cedar Park, TexasHospital not named in the registryNo longer taking part
  • Chesterfield, MichiganHospital not named in the registryNo longer taking part
  • Chevy Chase, MarylandHospital not named in the registryNo longer taking part
  • Chicago, IllinoisHospital not named in the registryNo longer taking part
  • Denver, ColoradoHospital not named in the registryNo longer taking part
  • Dublin, OhioHospital not named in the registryNo longer taking part
  • Garland, TexasHospital not named in the registryNo longer taking part
  • Leesburg, FloridaHospital not named in the registryNo longer taking part
  • Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
  • Morristown, New JerseyHospital not named in the registryNo longer taking part
  • Nashville, TennesseeHospital not named in the registryNo longer taking part
  • New Windsor, New YorkHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryNo longer taking part
  • North Charleston, South CarolinaHospital not named in the registryNo longer taking part
  • Northbrook, IllinoisHospital not named in the registryNo longer taking part
  • Philadelphia, PennsylvaniaHospital not named in the registryNo longer taking part
  • Raleigh, North CarolinaHospital not named in the registryNo longer taking part
  • Rochester, New YorkHospital not named in the registryNo longer taking part
  • Tacoma, WashingtonHospital not named in the registryNo longer taking part
  • Tampa, FloridaHospital not named in the registryNo longer taking part
  • Uniontown, PennsylvaniaHospital not named in the registryNo longer taking part
  • Ventura, CaliforniaHospital not named in the registryNo longer taking part
  • Warwick, Rhode IslandHospital not named in the registryNo longer taking part
  • West Jordan, UtahHospital not named in the registryNo longer taking part
  • Winter Park, FloridaHospital not named in the registryNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).

A vizsgálat 4 csoportja

  • PRV-015 Low DoseA vizsgált kezelés

    PRV-015 Low Dose, sterile solution for subcutaneous administration

    Kezelés: PRV-015

  • PRV-015 Medium DoseA vizsgált kezelés

    PRV-015 Medium Dose, sterile solution for subcutaneous administration

    Kezelés: PRV-015

  • PRV-015 High DoseA vizsgált kezelés

    PRV-015 High Dose, sterile solution for subcutaneous administration

    Kezelés: PRV-015

  • PlaceboPlacebo, összehasonlításként

    Placebo, sterile solution for subcutaneous administration

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients With Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet
A regiszteradat frissítve
2025. október 20.