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An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis ((HOPE-1))

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ClinicalTrials.gov Identifier: NCT03229252
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Spyryx Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE July 14, 2017
First Posted Date  ICMJE July 25, 2017
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
Change in percent predicted FEV1 [ Time Frame: Baseline and Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03229252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
  • Number of participants with adverse events [ Time Frame: Day 1 through Day 28 ]
  • Change from baseline through Day 28 in clinical laboratory tests [ Time Frame: Day 1 through Day 28 ]
    Chemistry, Hematology, Urinalysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness)
Brief Summary 28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-Blind
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • Drug: Placebo Inhalation Solution
    Normal Saline Inhalation Solution
  • Drug: SPX-101
    SPX-101 Inhalation Solution
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo Inhalation solution twice daily for 28 days.
    Intervention: Drug: Placebo Inhalation Solution
  • Experimental: SPX-101 Low Dose
    Inhalation solution twice daily for 28 days.
    Intervention: Drug: SPX-101
  • Experimental: SPX-101 High Dose
    Inhalation solution twice daily for 28 days.
    Intervention: Drug: SPX-101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2018)
90
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2017)
78
Estimated Study Completion Date  ICMJE May 15, 2019
Estimated Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of CF
  • ppFEV1 between 50.0% and 80.0%
  • Stable CF Lung Disease
  • Males and non-pregnant, non-lactating females

Exclusion Criteria:

  • Significant unstable co-morbidities within 28 days of screening
  • Has received an investigational drug within 28 days of screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lynn Smiley, MD 919-899-9399 contact@spyryxbio.com
Listed Location Countries  ICMJE Canada,   France,   Italy,   Portugal,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03229252
Other Study ID Numbers  ICMJE SPX-101-CF-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Spyryx Biosciences, Inc.
Study Sponsor  ICMJE Spyryx Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Spyryx Biosciences, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP