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

Study Identifier
M19-530
CT.gov Identifier
NCT03969888
EudraCT Identifier
2019-000750-63
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
Available Language(s): English, Dutch, French, Hungarian, Serbian, Slovak
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Study Details

Medical Condition
  • Cystic Fibrosis
    • Study Drug
  • ABBV-3067
  • Placebo ABBV-3067
  • ABBV-2222
  • Placebo ABBV-2222
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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 and \<= 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

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    University of Arkansas /ID# 212541
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    Tampa General Hospital /ID# 212342
    Tampa, Florida, United States, 33606
    Status
    Not applicable
    Location
    University of Iowa Hospitals and Clinics /ID# 212351
    Iowa City, Iowa, United States, 52242
    Status
    Not applicable
    Location
    Univ Michigan Med Ctr /ID# 212657
    Ann Arbor, Michigan, United States, 48109
    Status
    Not applicable
    Location
    Cardinal Glennon Children's Hospital /ID# 212349
    St Louis, Missouri, United States, 63104
    Status
    Not applicable
    Location
    Washington University-School of Medicine /ID# 212352
    St Louis, Missouri, United States, 63110
    Status
    Not applicable
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