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Résztvevőt keres itt: Egyesült Államok3. fázis

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

A legfontosabb adatok

Hol
Allen, Amarillo, Ann Arbor, Atlanta, Aurora, Austin, Baltimore, Beckley, Boca Raton, Boston, Boynton Beach, Charleston, Charlotte, Cleveland, Colleyville, Denver, Durham, El Paso, Fairway, Gainesville, Galveston, Great Neck, Harlingen, Houston, Irvine, Margate, Miami, Middleburg Heights, Milwaukee, New Haven, North Richland Hills, Orlando, Palm Beach Gardens, Philadelphia, Phoenix, Pittsburgh, Plant City, Sterling Heights, Summerville, Washington D.C. és Willowbrook (Egyesült Államok)Mind a 41 helyszín megnézése
Fázis
3. fázis

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

  • 18 és 75 év között vagy?

Forrás: NCT06455449: ki vehet részt

Helyszínek itt: Egyesült Államok

  • Allen, TexasHospital not named in the registryRésztvevőt keres
  • Amarillo, TexasHospital not named in the registryRésztvevőt keres
  • Ann Arbor, MichiganHospital not named in the registryRésztvevőt keres
  • Atlanta, GeorgiaHospital not named in the registryRésztvevőt keres
  • Aurora, ColoradoHospital not named in the registryRésztvevőt keres
  • Austin, TexasHospital not named in the registryRésztvevőt keres
  • Baltimore, MarylandHospital not named in the registryRésztvevőt keres
  • Beckley, West VirginiaHospital not named in the registryNo longer taking part
  • Boca Raton, FloridaHospital not named in the registryRésztvevőt keres
  • Boston, MassachusettsHospital not named in the registryRésztvevőt keres
  • Boynton Beach, FloridaHospital not named in the registryNo longer taking part
  • Charleston, West VirginiaHospital not named in the registryRésztvevőt keres
  • Charlotte, North CarolinaHospital not named in the registryNo longer taking part
  • Cleveland, OhioHospital not named in the registryRésztvevőt keres
  • Colleyville, TexasHospital not named in the registryRésztvevőt keres
  • Denver, ColoradoHospital not named in the registryRésztvevőt keres
  • Durham, North CarolinaHospital not named in the registryRésztvevőt keres
  • El Paso, TexasHospital not named in the registryRésztvevőt keres
  • Fairway, KansasHospital not named in the registryRésztvevőt keres
  • Gainesville, FloridaHospital not named in the registryNo longer taking part
  • Galveston, TexasHospital not named in the registryNo longer taking part
  • Great Neck, New YorkHospital not named in the registryRésztvevőt keres
  • Harlingen, TexasHospital not named in the registryRésztvevőt keres
  • Houston, TexasHospital not named in the registryNo longer taking part
  • Irvine, CaliforniaHospital not named in the registryRésztvevőt keres
  • Margate, FloridaHospital not named in the registryRésztvevőt keres
  • Miami, FloridaHospital not named in the registryNo longer taking part
  • Middleburg Heights, OhioHospital not named in the registryNo longer taking part
  • Milwaukee, WisconsinHospital not named in the registryRésztvevőt keres
  • New Haven, ConnecticutHospital not named in the registryRésztvevőt keres
  • North Richland Hills, TexasHospital not named in the registryRésztvevőt keres
  • Orlando, FloridaHospital not named in the registryRésztvevőt keres
  • Palm Beach Gardens, FloridaHospital not named in the registryRésztvevőt keres
  • Philadelphia, PennsylvaniaHospital not named in the registryToborzás még nem indult
  • Phoenix, ArizonaHospital not named in the registryToborzás még nem indult
  • Pittsburgh, PennsylvaniaHospital not named in the registryRésztvevőt keres
  • Plant City, FloridaHospital not named in the registryRésztvevőt keres
  • Sterling Heights, MichiganHospital not named in the registryRésztvevőt keres
  • Summerville, South CarolinaHospital not named in the registryRésztvevőt keres
  • Washington D.C., District of ColumbiaHospital not named in the registryNo longer taking part
  • Willowbrook, IllinoisHospital not named in the registryRésztvevőt keres

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

A vizsgálat adatai

Ki végzi
AstraZeneca
Azonosító
NCT06455449
A regiszteradat frissítve
2026. szeptember 24.
Eredeti leírás
The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.A teljes eredeti leírásKevesebb

A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.

Bevonási feltételek: 18 - 75 years old; Body weight ≥40 kg; Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis; Moderate or severe disease activity per core set measurements; Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose; No history of active tuberculosis or severe COVID-19; Male and female participants must follow contraception guidelines.

Kizáró feltételek: Participants with documented inclusion body myositis (IBM), immune mediation necrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years prior to signing the ICF), drug-induced myositis, cancer associated myositis, amyopathic DM, and non inflammatory myopathies (eg, muscular dystrophies); Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF; Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization; Recent or concurrent enrollment in another clinical study with an investigational product; PM and DM patients at a high risk of malignancy; Participants with rapidly progressive interstitial lung disease; Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per the investigator's opinion; Any history of severe case of herpes zoster infection; History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV ; Recent non-opportunistic infection requiring hospitalization or anti-infective treatment; Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding.

Capable of giving informed consent.

ClinicalTrials.gov NCT06455449