A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Purpose
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.
Condition
- Cystic Fibrosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1: ABBV-3067 + Placebo |
Participants will receive various dosing regimens for ABBV-3067 plus placebo ABBV-2222 taken orally depending on arm assignment. |
|
|
Experimental Part 1: ABBV-3067 + ABBV-2222 |
Participants will receive fixed dose of ABBV-3067 plus various dosing regimens for ABBV-2222 taken orally depending on arm assignment. |
|
|
Placebo Comparator Part 1 and Part 2: Placebo |
Participants in Part 1 and Part 2 will receive placebo ABBV-3067 plus placebo ABBV-2222 taken orally. |
|
|
Experimental Part 2: ABBV-3067 + ABBV-2222 |
Participants will receive various dosing regimens for ABBV-3067 plus a fixed dose of ABBV-2222 taken orally depending on arm assignment. |
|
Recruiting Locations
More Details
- NCT ID
- NCT03969888
- Status
- Completed
- Sponsor
- AbbVie