EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02443688
• Date of registration: 08/05/2015
• Prospective Registration: Yes
• Primary sponsor: Celtaxsys, Inc.
• Public title: EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients
• Scientific title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients With Cystic Fibrosis
• Date of first enrolment: October 30, 2015
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02443688
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, France, Germany, Italy, United Kingdom, United States

Contacts

• Name: Stuart Elborn, MD
• Affiliation: Royal Brompton Hospital, London UK

• Name: Steven Rowe, MD
• Affiliation: University of Alabama at Birmingham, USA

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 30 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: CTX-4430

Drug: Placebo

Primary Outcome(s)

Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1) [Time Frame: Baseline, Week 48]

Secondary Outcome(s)

Change From Baseline for C-reactive Protein (Hs-CRP) [Time Frame: Baseline, Week 48]

Subjects Without a Pulmonary Exacerbation While in the Study [Time Frame: Week 48]

Change From Baseline for Specified Biomarkers [Time Frame: Baseline, Week 48]

Hazard Ratio Pulmonary Exacerbation While in the Study [Time Frame: Week 48]

Number of Pulmonary Exacerbations Through 48 Weeks [Time Frame: Week 48]

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 [Time Frame: Baseline, Week 48]

Relative Change (Percent Change) From Baseline in ppFEV1 [Time Frame: Baseline, Week 48]

Secondary ID(s)

CTX-4430-CF-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02443688