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

Last updated: August 22, 2019
Sponsor: Celtaxsys, Inc.
Overall Status: Completed

Phase

2

Condition

Cystic Fibrosis

Scar Tissue

Lung Disease

Treatment

N/A

Clinical Study ID

NCT02443688
CTX-4430-CF-201
  • Ages 18-30
  • All Genders

Study 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

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

Exclusion Criteria:

  • Pregnant or nursing women

  • Medical condition that is unstable, could be adversely impacted by participation inthe 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

Study Design

Total Participants: 200
Study Start date:
October 30, 2015
Estimated Completion Date:
May 16, 2018

Study 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).

Connect with a study center

  • Hôpital Erasme

    Brussels,
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven,
    Belgium

    Site Not Available

  • University of Calgary

    Calgary, Alberta T2N 4N1
    Canada

    Site Not Available

  • Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario m5B 1W8
    Canada

    Site Not Available

  • Centre hospitalier de Dunkerque

    Dunkerque,
    France

    Site Not Available

  • Hôpital Albert Michallon

    Grenoble,
    France

    Site Not Available

  • Hopital Arnaud de Villeneuve

    Montpellier, Cedex 5
    France

    Site Not Available

  • Hôpital Cochin

    Paris,
    France

    Site Not Available

  • CH Lyon Sud

    Pierre Benite,
    France

    Site Not Available

  • Centre de Perharidy

    Roscoff,
    France

    Site Not Available

  • Charite' University

    Berlin, 10117
    Germany

    Site Not Available

  • Krankenhaus Donaustauf

    Donaustauf,
    Germany

    Site Not Available

  • Carl-Gustav-Klinikum Dresden, Mukoviszidose Centrum "Christiane Herzog"

    Dresden,
    Germany

    Site Not Available

  • Ruhrlandklinik Essen

    Essen,
    Germany

    Site Not Available

  • Institut für klinische Forschung Pneumologie

    Frankfurt,
    Germany

    Site Not Available

  • Klinikum der Johann Wolfgang Goethe-Universität

    Frankfurt,
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover,
    Germany

    Site Not Available

  • Universitätsklinikum Jena CF Centre

    Jena, 07740
    Germany

    Site Not Available

  • Lungenärztliche Praxis München-Pasing

    München-Pasing,
    Germany

    Site Not Available

  • Klinikum Stuttgart CF Ambulanz

    Stuttgart,
    Germany

    Site Not Available

  • Ospedali Riuniti di Ancona

    Ancona,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria

    Catania,
    Italy

    Site Not Available

  • Azienda Ospedaliera A Meyer

    Florence,
    Italy

    Site Not Available

  • IRCCS Ospedale Pediatrico Bambino

    Rome,
    Italy

    Site Not Available

  • Ospedale Civile Maggiore

    Verona,
    Italy

    Site Not Available

  • Frimley Park hospital

    Frimley, Surrey GU16 7UJ
    United Kingdom

    Site Not Available

  • Belfast City Hospital

    Belfast,
    United Kingdom

    Site Not Available

  • Bristol Royal Infirmary

    Bristol, BS2 8HW
    United Kingdom

    Site Not Available

  • Llandough Hospital

    Cardiff, CF64 2XX
    United Kingdom

    Site Not Available

  • Frimley Park hospital

    Frimley Surrey, GU16 7UJ
    United Kingdom

    Site Not Available

  • South Glasgow University Hospital

    Glasgow,
    United Kingdom

    Site Not Available

  • St James's University Hospital

    Leeds, LS97TF
    United Kingdom

    Site Not Available

  • Liverpool Heart and Chest Hospital

    Liverpool,
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital

    London,
    United Kingdom

    Site Not Available

  • University Hospital of South Manchester

    Manchester,
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle Upon Tyne,
    United Kingdom

    Site Not Available

  • University Hospital Southampton

    Southampton,
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital

    Stoke on Trent,
    United Kingdom

    Site Not Available

  • University of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Providence Health and Services

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Banner University of Arizona Medical Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Childrens Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Pediatric Pulmonary and Cystic Fibrosis Clinic, Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • University of California Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Central Florida Pulmonary Group

    Orlando, Florida 32803
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • St. Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Maine Medical Center

    Portland, Maine 04106
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 49286
    United States

    Site Not Available

  • Harper University Hospital

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Spectrum Health Butterworth Campus

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • University of New Mexico

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Albany Medical College

    Albany, New York 12208
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Wake Forest Hospital

    Winston Salem, North Carolina 27157
    United States

    Site Not Available

  • Wake Forest Hospital

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • UC Cincinnati Children's Hospital

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Oregon Health & Sciences University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Drexel University

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Sanford Clinical Research

    Sioux Falls, South Dakota 57104
    United States

    Site Not Available

  • Universiy of Tennessee Medical Center UHS

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Dell Children's Medical Center

    Austin, Texas 78723
    United States

    Site Not Available

  • Cook Children's Hospital

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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