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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT03969888

Run by

AbbVie

People needed

78

Starts

2019-12-11

Expected to finish

2022-06-09

Last updated by the study team

2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History of solid organ or hematopoietic transplant
• Cirrhosis with portal hypertension
• Use of CFTR modulator therapy within 60 days prior to Screening

Where it is running

• Tampa General Hospital /ID# 212342 — Tampa, Florida, United States
• University of Iowa Hospitals and Clinics /ID# 212351 — Iowa City, Iowa, United States
• Univ Michigan Med Ctr /ID# 212657 — Ann Arbor, Michigan, United States
• Cardinal Glennon Children's Hospital /ID# 212349 — St Louis, Missouri, United States
• Washington University-School of Medicine /ID# 212352 — St Louis, Missouri, United States
• Nationwide Children's Hospital /ID# 213158 — Columbus, Ohio, United States
• Medical University of South Carolina /ID# 212187 — Charleston, South Carolina, United States
• Vanderbilt University Medical Center /ID# 212353 — Nashville, Tennessee, United States
• University of Utah /ID# 212350 — Salt Lake City, Utah, United States
• Uza /Id# 213412 — Edegem, Antwerpen, Belgium
• Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 213413 — Brussels, Brussels Capital, Belgium
• UZ Brussel /ID# 212812 — Jette, Brussels Capital, Belgium
• UZ Gent /ID# 213411 — Ghent, Oost-Vlaanderen, Belgium
• Universitair Ziekenhuis Leuven /ID# 213050 — Leuven, Vlaams-Brabant, Belgium
• University of Calgary /ID# 212555 — Calgary, Alberta, Canada
• St. Paul's Hospital /ID# 212554 — Vancouver, British Columbia, Canada
• QEII - Health Sciences Centre /ID# 212656 — Halifax, Nova Scotia, Canada
• Unity Health Toronto - St. Michael's Hospital /ID# 212552 — Toronto, Ontario, Canada
• CHUM - Centre hospitalier de l'Universite de Montréal /ID# 227815 — Montreal, Quebec, Canada
• McGill University Health Center Research Institute /ID# 212553 — Montreal, Quebec, Canada
• Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 212655 — Québec, Quebec, Canada
• Fakultni Nemocnice Brno /ID# 213437 — Brno, Czechia
• Fakultni Nemocnice v Motole /ID# 212966 — Prague, Czechia
• Chu de Nice-Hopital L'Archet Ii /Id# 212862 — Nice, Alpes-Maritimes, France
• University of Arkansas /ID# 212541 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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