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
Public ClinicalTrials.gov record NCT04853368. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04853368
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 20, 2021 (Actual)
- Primary completion
- Jun 5, 2023 (Actual)
- Completion
- Jun 5, 2023 (Actual)
- Last update posted
- Jul 16, 2024
2021 – 2023
United States locations
- U.S. sites
- 22
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Velocity Clinical Research /ID# 248675 | Mobile | Alabama | 36608-1771 | — |
| University of Southern California /ID# 249147 | Los Angeles | California | 90030 | — |
| Ventura County Medical Center /ID# 248586 | Ventura | California | 93003-1651 | — |
| Central FL Pulmonary Orlando /ID# 245432 | Orlando | Florida | 32803 | — |
| University of Kansas Health Sy /ID# 249056 | Kansas City | Kansas | 66160-8500 | — |
| Boston Children's Hospital /ID# 248646 | Boston | Massachusetts | 02115 | — |
| Harper University Hospital /ID# 248917 | Detroit | Michigan | 48201 | — |
| Washington University-School of Medicine /ID# 245393 | St Louis | Missouri | 63110 | — |
| Dartmouth-Hitchcock Medical Center /ID# 245706 | Lebanon | New Hampshire | 03756 | — |
| Dartmouth Hitchcock Manchester /ID# 248795 | Manchester | New Hampshire | 03104-4125 | — |
| Albany Medical College-Pulmonary /ID# 248838 | Albany | New York | 12208-3504 | — |
| Northwell Health/Long Island Jewish Hospital /ID# 248916 | New Hyde Park | New York | 11042 | — |
| New York Medical College /ID# 248640 | Valhalla | New York | 10595 | — |
| UH Cleveland Medical Center /ID# 245433 | Cleveland | Ohio | 44106 | — |
| ProMedica Toledo Harris McIntosh /ID# 248627 | Toledo | Ohio | 43606-3845 | — |
| University of Oklahoma HSC /ID# 249190 | Oklahoma City | Oklahoma | 73104-5410 | — |
| Penn State Health /ID# 248585 | Hershey | Pennsylvania | 17033 | — |
| Medical University of South Carolina /ID# 245403 | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center /ID# 245400 | Nashville | Tennessee | 37232 | — |
| The Univ Texas HSC at Tyler /ID# 248498 | Tyler | Texas | 75708 | — |
| Children's Hospital of Richmond at VCU /ID# 248561 | Richmond | Virginia | 23298 | — |
| Medical College of Wisconsin - Plank Rd /ID# 249079 | Milwaukee | Wisconsin | 53226-3548 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04853368, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 16, 2024 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04853368 live on ClinicalTrials.gov.