A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222

• Status: Recruiting
• Trial end date: 2022-10-22
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie

Criteria

Inclusion Criteria:

• Confirmed clinical diagnosis of Cystic Fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation

• Stable pulmonary status

• Lung function >= 40 and <= 90% of predicted normal for age, gender and height at Screening

Exclusion Criteria:

• History of solid organ or hematopoietic transplant

• Cirrhosis with portal hypertension

• Use of CFTR modulator therapy within 60 days prior to Screening