Phase 2
Completed N=78
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Source: ClinicalTrials.gov NCT03969888 ↗Enrolled (actual)
78
Serious AEs
2.6%
Results posted
Jun 2023
Primary outcomePrimary: Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — 0.3; -2.2; 2.0; 4.5 percent predicted FEV1 (%)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) |
0.3; -2.2; 2.0; 4.5; 0.3; 4.0 | — |
| SECONDARY Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) |
-4.5; -8.9; -2.3; -15.7; -12.3; -18.6 | — |
| SECONDARY Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) |
0.0; -0.0; 0.0; 0.1; 0.1; 0.0 | — |
| SECONDARY Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) |
0.0; -0.0; 0.2; 0.2; -0.0; 0.3 | — |
| SECONDARY Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) |
1.0; -2.9; 3.4; 8.0; 1.4; 5.7 | — |
| SECONDARY Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) |
0.8; -0.1; 8.8; 19.9; 0.1; 18.5 | — |
| SECONDARY Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) |
0.1; -1.0; 0.2; 2.2; 2.2; 0.9 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03969888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.