A Phase 2 study of ABBV-3067 alone and in combination with ABBV-2222

Details

Therapeutic category
Restore CFTR Function
Trial status
closed Participating Centres
Phase
Phase II

Full title

A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation

In this study, participants will be given ABBV-3067 (“potentiator”) and ABBV-2222 (“corrector”) to see if treatment improves participants’ lung function. Different groups of participants will receive different doses, and some will receive a dummy drug (“placebo”). This study evaluates the safety and efficacy (how well the medications work) of the medications and the best dose of each medicine to be used in future studies. This is a Phase 2, double-blinded (treatment type is unknown to participants and investigators) study in people with CF who have two copies of the F508del mutation (the most common CFTR gene mutation). Participants go through a screening process (up to a month) and receive study treatment for up to a month, followed by a review, a month later. Tests done for the study include lung function tests, sweat chloride tests, blood and urine tests, and ECG. Side effects are monitored through the course of the study.
Trial Reference Number
123868
Trial type
Medication
Intervention
CFTR Modulators
Recruitment target
189
Last edited date
13/07/2020
CF sponsor
AbbVie
CF sponsor type
Commercial

Who can take part?

Top inclusion criteria
  • Homozygous for the F508del Mutation (2 copies of F508d)
  • 18 Years and older
  • Lung function > 40 and <90%
Top exclusion criteria
  • Cirrhosis with portal hypertension
  • Use of CFTR modulator therapy within 60 days prior to Screening

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