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ongoing trials trial from www.clinicaltrials.gov

Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Adult Participants With Cystic Fibrosis - Phase 2 - Not yet recruiting

  • Year: 2021
  • Date: June 29, 2021
  • Author: AbbVie
Source

https://ClinicalTrials.gov/show/NCT04853368

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment

Participants

Cystic Fibrosis (CF) - 18 Years and older   (Adult, Older Adult)

Interventions

Drug: Galicaftor|Drug: Placebo|Drug: Navocaftor|Drug: ABBV-119

Outcome measures

Absolute Change From Baseline in ppFEV1|Absolute Change From Baseline in Sweat Chloride (SwCl)|Absolute Change From Baseline in Forced Vital Capacity [FVC]|Absolute Change From Baseline in Forced Expiratory Flow at Mid-Lung Capacity [FEF25-75]|Relative Changes From Baseline in ppFEV1|Relative Changes From Baseline in FVC|Relative Changes From Baseline in FEF25-75|Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline

Keywords: Adult; Aminophenols; CFTR Modulators; Genetic Predisposition to Disease; pharmacological_intervention; Galicaftor; Navocaftor; ABBV119;