Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutatio
Phase 1
- Conditions
- Cystic FibrosisMedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2019-000750-63-PL
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 189
Inclusion Criteria
*Adults 18 years or older
*Confirmed diagnosis of CF and homozygous for F508del CFTR mutation
*Lung function = 40% and = 90% of predicted normal for age, gender, and height
*Stable pulmonary status
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 189
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
*Cirrhosis with portal hypertension
*History of solid organ or hematopoietic transplantation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In Part 1 of the study, a fixed dose of ABBV-3067 (potentiator) will be co-administered with ABBV-2222 (corrector) in a dose range-finding manner to enable a dose selection for ABBV-2222 for Part 2 and future combination studies. In addition, ABBV-3067 will be given alone (i.e. with placebo for ABBV-2222) to evaluate the safety and efficacy of ABBV-3067. <br>In Part 2 of the study, the dose of ABBV-2222 selected from Part 1 will be co-administered with ABBV-3067 in a dose-ranging manner to enable selection of the ABBV-3067 dose for future combination studies. ;Secondary Objective: Not Applicable;Primary end point(s): Change from Baseline through Day 29 in overall lung function.;Timepoint(s) of evaluation of this end point: Change from Baseline through Day 29
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Change from Baseline through Day 29 in sweat chloride <br>2) Change from Baseline through Day 29 in other spirometric measures <br>3) Change from Baseline through Day 29 in lung function;Timepoint(s) of evaluation of this end point: Change from baseline through Day 29