A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Cystic Fibrosis / Posted 4 weeks 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.
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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
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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