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A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa

A legfontosabb adatok

Ki végzi
Avalo Therapeutics, Inc.
Hol
Arlington, Boca Raton, Boston, Bowling Green, Brooklyn, Chicago, Cincinnati, Cleveland, Coral Gables, Detroit, Dublin, Fort Gratiot, Greenville, Johnston, Maitland, Murray, New York, North Miami Beach, Northridge, Oakland, Philadelphia, Pittsburgh, Pomona, Portsmouth, Providence, Sacramento, Santa Monica, Savannah, Scottsdale, Tampa, The Bronx, Tucson, Washington D.C. és West Lafayette (Egyesült Államok)Mind a 36 helyszín megnézéseMég 12 másik országban, 58 helyszínen
Állapot
Befejeződött
Fázis
2. fázis
Résztvevők
253 fő vett részt
Kezdés
2024. szept. 16.
Befejezés
2026. márc. 17.
A vizsgálat típusa
Beavatkozással járó, 3 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • AVTX-009 Regimen 1
  • AVTX-009 Regimen 2
  • Placebo
A regiszteradat frissítve
2026. április 21.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 6 feltétel megnézéseKevesebb

Ki vehet részt

  • Signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior to Screening
  • At least 5 inflammatory lesions in at least 2 distinct anatomical areas, at least 1 of which is Hurley Stage 2 or 3

Ki nem vehet részt

  • Has another active skin inflammatory condition, infection (viral, bacterial, or fungal), or another active ongoing inflammatory disease (other than HS) that requires treatment with a prohibited medication, which could interfere with the assessment of HS
  • History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic lung infection, recurrent urinary tract infection, or open, draining or infected skin wounds or ulcers (not related to HS)
  • Has severe, progressive and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or immunosuppressive disease
  • Has a draining fistula count of ≥ 20

Helyszínek itt: Egyesült Államok

Még 12 másik országban, 58 helyszínen

  • Arlington, TexasHospital not named in the registryNo longer taking part
  • Boca Raton, FloridaHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital not named in the registryNo longer taking part
  • Bowling Green, KentuckyHospital not named in the registryNo longer taking part
  • Brooklyn, New YorkHospital not named in the registryNo longer taking part
  • Chicago, IllinoisHospital not named in the registryNo longer taking part
  • Cincinnati, OhioHospital not named in the registryNo longer taking part
  • Cleveland, OhioHospital not named in the registryNo longer taking part
  • Coral Gables, FloridaHospital not named in the registryNo longer taking part
  • Detroit, MichiganHospital not named in the registryNo longer taking part
  • Dublin, OhioHospital not named in the registryNo longer taking part
  • Fort Gratiot, MichiganHospital not named in the registryNo longer taking part
  • Greenville, South CarolinaHospital not named in the registryNo longer taking part
  • Johnston, Rhode IslandHospital not named in the registryNo longer taking part
  • Maitland, FloridaHospital not named in the registryNo longer taking part
  • Murray, KentuckyHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryNo longer taking part
  • North Miami Beach, FloridaHospital not named in the registryNo longer taking part
  • Northridge, CaliforniaHospital not named in the registryNo longer taking part
  • Oakland, MichiganHospital not named in the registryNo longer taking part
  • Philadelphia, PennsylvaniaHospital not named in the registryNo longer taking part
  • Pittsburgh, PennsylvaniaHospital not named in the registryNo longer taking part
  • Pomona, CaliforniaHospital not named in the registryNo longer taking part
  • Portsmouth, New HampshireHospital not named in the registryNo longer taking part
  • Providence, Rhode IslandHospital not named in the registryNo longer taking part
  • Sacramento, CaliforniaHospital not named in the registryNo longer taking part
  • Santa Monica, CaliforniaHospital not named in the registryNo longer taking part
  • Savannah, GeorgiaHospital not named in the registryNo longer taking part
  • Scottsdale, ArizonaHospital not named in the registryNo longer taking part
  • Scottsdale, ArizonaHospital not named in the registryNo longer taking part
  • Tampa, FloridaHospital not named in the registryNo longer taking part
  • The Bronx, New YorkHospital not named in the registryNo longer taking part
  • Tucson, ArizonaHospital not named in the registryNo longer taking part
  • Washington D.C., District of ColumbiaHospital not named in the registryNo longer taking part
  • West Lafayette, IndianaHospital not named in the registryNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

The main purpose of this study is to evaluate the efficacy and safety of AVTX-009 compared with placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).

A vizsgálat 3 csoportja

  • AVTX-009 Regimen 1A vizsgált kezelés

    Patients will receive AVTX-009 regimen 1.

  • AVTX-009 Regimen 2A vizsgált kezelés

    Patients will receive AVTX-009 regimen 2.

  • PlaceboPlacebo, összehasonlításként

    Patients will receive matching placebo.

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
Hivatalos cím
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa (LOTUS)
A regiszteradat frissítve
2026. április 21.