Trial · NCT02443688

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

NCT02443688, Phase 2, Completed, Celtaxsys, Inc.; results first posted 2019-07-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients. Trials, record NCT02443688. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02443688

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients
NCT number: NCT02443688
Status: Completed
Phases: Phase 2
Enrollment: 200 participants, actual
Lead sponsor: Celtaxsys, Inc.
Conditions: Cystic Fibrosis
Interventions: CTX-4430, Placebo
First posted: 2015-05-14
Last updated: 2019-09-04
Results first posted: 2019-07-25

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1)	Baseline, Week 48	Difference from Placebo in absolute change from Baseline at Week 48 was assessed for FEV1 percent predicted.
Secondary	Number of Pulmonary Exacerbations Through 48 Weeks	Week 48	Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression.
Secondary	Hazard Ratio Pulmonary Exacerbation While in the Study	Week 48	Hazard Ratio of pulmonary exacerbation versus placebo for all subjects. Pulmonary exacerbations are defined as treatment with oral, inhaled, or intravenous antibiotic(s) for ≥4 of symptoms/signs per the modified Fuchs criteria.
Secondary	Subjects Without a Pulmonary Exacerbation While in the Study	Week 48	Subjects who did not experience a protocol-defined pulmonary exacerbation during the study
Secondary	Relative Change (Percent Change) From Baseline in ppFEV1	Baseline, Week 48	Percent change from Baseline for ppFEV1 at 48 weeks was assessed.
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	Baseline, Week 48
Secondary	Change From Baseline for Specified Biomarkers	Baseline, Week 48	Results were only calculated in subjects who had a verifiable result at the Baseline and Week 48 visits.
Secondary	Change From Baseline for C-reactive Protein (Hs-CRP)	Baseline, Week 48	Results were only calculated in subjects who had a verifiable result at the Baseline and Week 48 visits.
Other	Number of Pulmonary Exacerbation Per Year for Participants With ppFEV1 >75 at Baseline	Week 48	Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression.
Other	Hazard Ratio Pulmonary Exacerbation for Participants With ppFEV1 >75 at Baseline	Week 48	Hazard ratio of pulmonary exacerbation versus placebo for all subjects

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1)	Baseline, Week 48	Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. The primary analysis was based upon the pooled results of the 100mg and 50mg doses.	FEV1 percent predicted	MEAN
SECONDARY	Number of Pulmonary Exacerbations Through 48 Weeks	Week 48	Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.	pulmonary exacerbations per year	MEAN
SECONDARY	Hazard Ratio Pulmonary Exacerbation While in the Study	Week 48	Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.	hazard ratio	NUMBER
SECONDARY	Subjects Without a Pulmonary Exacerbation While in the Study	Week 48	Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Relative Change (Percent Change) From Baseline in ppFEV1	Baseline, Week 48	Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. (Observed Data). The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.	percent change from baseline	MEAN
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	Baseline, Week 48	Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. (Observed Data). The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.	absolute change of percent predicted	MEAN
SECONDARY	Change From Baseline for Specified Biomarkers	Baseline, Week 48	Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment and who had results at Baseline and Week 48. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.	log10(mcg/mL)	MEAN
SECONDARY	Change From Baseline for C-reactive Protein (Hs-CRP)	Baseline, Week 48	Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment and who had results at Baseline and Week 48. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.	mg/dL	MEAN
OTHER_PRE_SPECIFIED	Number of Pulmonary Exacerbation Per Year for Participants With ppFEV1 >75 at Baseline	Week 48	Population of subjects with Baseline ppFEV1 \>75. The statistical analysis plans states the two active doses will be compared to placebo individually as well as combined. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.	pulmonary exacerbations per year	MEAN
OTHER_PRE_SPECIFIED	Hazard Ratio Pulmonary Exacerbation for Participants With ppFEV1 >75 at Baseline	Week 48	Population of subjects with Baseline ppFEV1 \>75. The statistical analysis plan states the two active doses will be compared to placebo individually as well as pooled.	hazard ratio	NUMBER

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group85

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1)	100 mg CTX-4430	-1.30	95% Confidence Interval -3.22 to 0.62	FEV1 percent predicted
Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1)	50 mg CTX-4430	-3.76	95% Confidence Interval -5.65 to -1.86	FEV1 percent predicted
Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1)	Pooled CTX-4430	-2.53	95% Confidence Interval -3.88 to -1.18	FEV1 percent predicted
Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1)	Matching Placebo	-2.69	95% Confidence Interval -4.63 to -0.75	FEV1 percent predicted
Number of Pulmonary Exacerbations Through 48 Weeks	100 mg CTX-4430	1.57	95% Confidence Interval 1.22 to 2.02	pulmonary exacerbations per year
Number of Pulmonary Exacerbations Through 48 Weeks	50 mg CTX-4430	1.46	95% Confidence Interval 1.13 to 1.89	pulmonary exacerbations per year
Number of Pulmonary Exacerbations Through 48 Weeks	Pooled CTX-4430	1.51	95% Confidence Interval 1.26 to 1.81	pulmonary exacerbations per year
Number of Pulmonary Exacerbations Through 48 Weeks	Matching Placebo	1.56	95% Confidence Interval 1.21 to 2.01	pulmonary exacerbations per year
Hazard Ratio Pulmonary Exacerbation While in the Study	100 mg CTX-4430	0.88	95% Confidence Interval 0.576 to 1.339	hazard ratio
Hazard Ratio Pulmonary Exacerbation While in the Study	50 mg CTX-4430	0.86	95% Confidence Interval 0.563 to 1.308	hazard ratio

1 to 10 of 85Source ClinicalTrials.gov

See all 85 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	100 mg CTX-4430	66
Overall Study	STARTED	50 mg CTX-4430	67
Overall Study	STARTED	Matching Placebo	67
Overall Study	COMPLETED	100 mg CTX-4430	54
Overall Study	COMPLETED	50 mg CTX-4430	58
Overall Study	COMPLETED	Matching Placebo	55
Overall Study	NOT COMPLETED	100 mg CTX-4430	12
Overall Study	NOT COMPLETED	50 mg CTX-4430	9
Overall Study	NOT COMPLETED	Matching Placebo	12

Source ClinicalTrials.gov

Adverse events180

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Infective pulmonary exacerbation of cystic fibrosis	Infections and infestations	100 mg CTX-4430	43	66
other	Infective pulmonary exacerbation of cystic fibrosis	Infections and infestations	50 mg CTX-4430	45	67
other	Infective pulmonary exacerbation of cystic fibrosis	Infections and infestations	Matching Placebo	49	66
other	Cough	Respiratory, thoracic and mediastinal disorders	100 mg CTX-4430	29	66
other	Cough	Respiratory, thoracic and mediastinal disorders	50 mg CTX-4430	27	67
other	Cough	Respiratory, thoracic and mediastinal disorders	Matching Placebo	21	66
other	Haemoptysis	Respiratory, thoracic and mediastinal disorders	100 mg CTX-4430	12	66
other	Haemoptysis	Respiratory, thoracic and mediastinal disorders	50 mg CTX-4430	17	67
other	Haemoptysis	Respiratory, thoracic and mediastinal disorders	Matching Placebo	11	66
other	Nasopharyngitis	Infections and infestations	100 mg CTX-4430	14	66

1 to 10 of 180Source ClinicalTrials.gov

See all 180 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	100 mg CTX-4430	0	66
Total, all-cause mortality	50 mg CTX-4430	0	67
Total, all-cause mortality	Matching Placebo	0	66
Total, other adverse events	100 mg CTX-4430	66	66
Total, other adverse events	50 mg CTX-4430	67	67
Total, other adverse events	Matching Placebo	65	66
Total, serious adverse events	100 mg CTX-4430	27	66
Total, serious adverse events	50 mg CTX-4430	26	67
Total, serious adverse events	Matching Placebo	21	66

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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