A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222

 Cystic Fibrosis / Posted 5 months ago

This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.

  • Inclusion Criteria :
    • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
    • Sexes Eligible for Study: All
    • Accepts Healthy Volunteers: No
    • Confirmed clinical diagnosis of Cystic Fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation
    • Stable pulmonary status
    • Lung function 40% - 90% of predicted normal for age, gender and height at screening
  • Exclusion Criteria :
    • History of solid organ or hematopoietic transplant
    • Cirrhosis with portal hypertension
    • Use of CFTR modulator therapy within 60 days prior to Screening
  • Study start date : December 11, 2019
  • Study end date : October 22, 2022
  • Wales-Based Study Contact : Please speak to your clinician
  • Principal Investigator : ABBVIE INC
Contact details

Cardiff & Vale University Health Board, School of Medicine, UHW Main Building Heath Park Campus CardiffCardiff,CF14 4XN abbvieclinicaltrials@abbvie.com

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