Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis (CF)

In brief

Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The main objective of this study is to assess how safe and effective is the combination therapy of galicaftor/navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 in adult participants with CF who are homozygous or heterozygous for the F508del mutation in each arm. Galicaftor/Navocaftor/ABBV-119 combination therapy and Galicaftor/Navocaftor/ABBV-576 is being developed as an investigational drug for the treatment of CF. Study doctors place participants in 1 of the 4 groups, called treatment arms. Each group receives a different treatment. Around 90 adult participants with a diagnosis of CF will be enrolled in the study around approximately 35 sites worldwide. Participants in arm 1 will receive oral capsules of galicaftor/navocaftor dual combination for 28 days followed by galicaftor/navocaftor/ABBV-119 triple combination for 28 days. Participants in arms 2 and 3 will receive the galicaftor/navocaftor/ABBV-119 triple combination or placebo for 28 days. Participants in arm 4 will receive galicaftor/navocaftor/ABBV-576 triple combination therapy for 28 days. For all study arms, ABBV-576, galicaftor, navocaftor, will be given once daily and ABBV-119 twice a day. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key facts

Study ID

NCT04853368

Run by

AbbVie

People needed

48

Starts

2021-09-20

Expected to finish

2023-06-05

Last updated by the study team

2024-07-16

Who can join

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

You may qualify if…

• Confirmed clinical diagnosis of cystic fibrosis (CF).
• Arm 1 participants with genotype homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation and not receiving elexacaftor/tezacaftor/ivacaftor (ETI) treatment .
• Arm 2 and 3 participants with genotype heterozygous for the F508del CFTR mutation and a minimal function mutation and not receiving ETI treatment.
• Arm 4 participants with genotype either homozygous or heterozygous for the F508del mutation. Participants must be receiving stable ETI treatment.
• Percent predicted forced expiratory volume in 1 second (ppFEV1) >= 40% and <=90% of predicted normal for age, gender and height at screening.
• For arms 1 and 2: sweat chloride (SwCl) >= 60 mmol/L at screening. For participants who participated in Study M19-530, it is acceptable to use a SwCl value that the central lab provided in Study M19-530 to establish eligibility.
• Weight >= 35 kg at screening and Day -28 for arm 1 or day 1 for arms 2 to 4.

You may not qualify if…

• Clinically significant laboratory values at screening that would pose undue risk for the participant or interfere with safety assessments (per the investigator).

Where it is running

• Velocity Clinical Research /ID# 248675 — Mobile, Alabama, United States
• University of Southern California /ID# 249147 — Los Angeles, California, United States
• Ventura County Medical Center /ID# 248586 — Ventura, California, United States
• Central FL Pulmonary Orlando /ID# 245432 — Orlando, Florida, United States
• University of Kansas Health Sy /ID# 249056 — Kansas City, Kansas, United States
• Boston Children's Hospital /ID# 248646 — Boston, Massachusetts, United States
• Harper University Hospital /ID# 248917 — Detroit, Michigan, United States
• Washington University-School of Medicine /ID# 245393 — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center /ID# 245706 — Lebanon, New Hampshire, United States
• Dartmouth Hitchcock Manchester /ID# 248795 — Manchester, New Hampshire, United States
• Albany Medical College-Pulmonary /ID# 248838 — Albany, New York, United States
• Northwell Health/Long Island Jewish Hospital /ID# 248916 — New Hyde Park, New York, United States
• New York Medical College /ID# 248640 — Valhalla, New York, United States
• UH Cleveland Medical Center /ID# 245433 — Cleveland, Ohio, United States
• ProMedica Toledo Harris McIntosh /ID# 248627 — Toledo, Ohio, United States
• University of Oklahoma HSC /ID# 249190 — Oklahoma City, Oklahoma, United States
• Penn State Health /ID# 248585 — Hershey, Pennsylvania, United States
• Medical University of South Carolina /ID# 245403 — Charleston, South Carolina, United States
• Vanderbilt University Medical Center /ID# 245400 — Nashville, Tennessee, United States
• The Univ Texas HSC at Tyler /ID# 248498 — Tyler, Texas, United States
• Children's Hospital of Richmond at VCU /ID# 248561 — Richmond, Virginia, United States
• Medical College of Wisconsin - Plank Rd /ID# 249079 — Milwaukee, Wisconsin, United States
• Royal Prince Alfred Hospital /ID# 228781 — Camperdown, New South Wales, Australia
• Westmead Hospital /ID# 227281 — Westmead, New South Wales, Australia
• Mater Misericordiae Limited /ID# 227279 — South Brisbane, Queensland, Australia

Full record on ClinicalTrials.gov

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