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

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ClinicalTrials.gov Identifier: NCT02443688
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Celtaxsys, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: CTX-4430 Drug: Placebo Phase 2

Detailed Description:
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. A total of 195 pulmonary CF patients that meet all the inclusion and no exclusion criteria and provide written informed consent will be randomized to receive 50 mg CTX-4430, 100 mg CTX-4430, or placebo in a 1:1:1 ratio. Follow-up visits will be conducted approximately every 4 weeks from Week 4 to Week 52 (4 weeks after completion of treatment).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 30, 2015
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : May 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 50 mg CTX-4430
Once daily oral capsule for 48 weeks
 Drug: CTX-4430
Experimental: 100 mg CTX-4430
Once daily oral capsule for 48 weeks
 Drug: CTX-4430
Placebo Comparator: Matching Placebo
Once daily oral capsule for 48 weeks
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the safety and tolerability of CTX-4430 administered orally once-daily to cystic fibrosis (CF) patients by the incidence of treatment emergent adverse events as compared to placebo. [ Time Frame: 52 weeks ]
  2. To evaluate the efficacy of CTX-4430 administered orally once-daily to CF patients as determined by the absolute change from Baseline in FEV1 (forced expiratory volume in 1 second) percent predicted [ Time Frame: 52 Weeks ]

Secondary Outcome Measures :
  1. To evaluate the efficacy of CTX-4430 administered orally once-daily to CF patients as determined by the relative change from Baseline in FEV1 percent predicted [ Time Frame: 52 weeks ]
  2. To evaluate the effect of CTX-4430 administered orally once-daily to CF patients on FVC (forced vital capacity) percent predicted and FEF25-75% (forced expiratory flow during the middle half of the forced vital capacity) percent predicted [ Time Frame: 52 weeks ]
  3. To evaluate the effect of CTX-4430 administered orally once-daily to CF patients on time to first pulmonary exacerbation while in the study [ Time Frame: 52 weeks ]
  4. To evaluate the effect of CTX-4430 administered orally once-daily to CF patients on the number of pulmonary exacerbations [ Time Frame: 52 weeks ]
  5. To evaluate the effect of CTX-4430 administered orally once-daily to CF patients on specified biomarkers [ Time Frame: 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443688


  Show 75 Study Locations
Sponsors and Collaborators
Celtaxsys, Inc.
Investigators
Principal Investigator: Steven Rowe, MD University of Alabama at Birmingham, USA
Principal Investigator: Stuart Elborn, MD Royal Brompton Hospital, London UK
More Information
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Responsible Party: Celtaxsys, Inc.
ClinicalTrials.gov Identifier: NCT02443688     History of Changes
Other Study ID Numbers: CTX-4430-CF-201
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases