Phase 2
N=200
EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02443688 ↗Enrolled (actual)
200
Serious AEs
37.2%
Results posted
Jul 2019
Primary outcome: Primary: Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1) — -1.30; -3.76; -2.53; -2.69 FEV1 percent predicted — p=0.45
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CTX-4430 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celtaxsys, Inc.
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1) |
-1.30; -3.76; -2.53; -2.69 | 0.45 |
| SECONDARY Number of Pulmonary Exacerbations Through 48 Weeks |
1.57; 1.46; 1.51; 1.56 | — |
| SECONDARY Hazard Ratio Pulmonary Exacerbation While in the Study |
0.88; 0.86; 0.87 | — |
| SECONDARY Subjects Without a Pulmonary Exacerbation While in the Study |
25; 26; 51; 20 | — |
| SECONDARY Relative Change (Percent Change) From Baseline in ppFEV1 |
-2.38; -4.81; -3.60; -3.40 | — |
| SECONDARY Change From Baseline at 48 Weeks for Forced Vital Capacity Percent Predicted (FVC) and FEF25-75% (Forced Expiratory Flow During the Middle Half of the Forced Vital Capacity) Percent Predicted |
-1.57; -2.06; -1.82; -1.41; -1.61; -4.79 | — |
| SECONDARY Change From Baseline for Specified Biomarkers |
0.06; 0.17; 0.12; -0.05; -0.02; 0.17 | — |
| SECONDARY Change From Baseline for C-reactive Protein (Hs-CRP) |
2.16; -0.33; 0.92; -1.87 | — |
Summary
This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.
Eligibility Criteria
Inclusion Criteria
- Forced expiratory volume at one second (FEV1) ≥50 percent predicted at Screening
- At least 1 pulmonary exacerbation in the 12 months before Screening
Exclusion Criteria
- Pregnant or nursing women
- Medical condition that is unstable, could be adversely impacted by participation in the study, or could impact assessment of the study results
- History of organ transplantation
- History of alcoholism or drug abuse within 2 years before Screening
- Regular use of a high-dose NSAID within 60 days before Screening
Data sourced from ClinicalTrials.gov (NCT02443688). 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.