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NCT04853368 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT04853368: Clinical Trial Phase 2 study, sponsored by AbbVie.
NCT04853368 is a Phase 2 study that was terminated before completion, run by AbbVie. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04853368, a Phase 2 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
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.
Primary Outcome
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.
Interventions
- DRUG Placebo
- DRUG Galicaftor
- DRUG Navocaftor
- DRUG ABBV-576
- DRUG ABBV-119
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-09-20 |
| Est. Completion | 2023-06-05 |
| Phase | Phase 2 |
Why NCT04853368 stopped before completion
NCT04853368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04853368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04853368 about?
NCT04853368 is a clinical study titled "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". 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 ...
What is the current status of trial NCT04853368?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2021-09-20. Estimated completion is 2023-06-05.
What interventions are being tested in trial NCT04853368?
The interventions under investigation include: Placebo (DRUG), Galicaftor (DRUG), Navocaftor (DRUG), ABBV-576 (DRUG), ABBV-119 (DRUG).
Who is sponsoring clinical trial NCT04853368?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04853368's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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