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

• ClinicalTrials.gov Identifier: NCT03229252
• Recruitment Status: Active, not recruiting
• First Posted: July 25, 2017
• Last Update Posted: May 24, 2019
• Sponsor: Spyryx Biosciences, Inc.
• Information provided by (Responsible Party): Spyryx Biosciences, Inc.

Tracking Information

• First Submitted Date: July 14, 2017
• First Posted Date: July 25, 2017
• Last Update Posted Date: May 24, 2019
• Actual Study Start Date: August 1, 2017
• Estimated Primary Completion Date: June 20, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 24, 2017): Change in percent predicted FEV1 [ Time Frame: Baseline and Day 28 ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03229252 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
• Official Title: 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: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Double-Blind

Primary Purpose: Treatment

• Condition: Cystic Fibrosis

Intervention

• Drug: Placebo Inhalation Solution
  Normal Saline Inhalation Solution
• Drug: SPX-101
  SPX-101 Inhalation Solution

Study Arms

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 23, 2019): 91
• Original Estimated Enrollment (submitted: July 24, 2017): 78
• Estimated Study Completion Date: June 20, 2019
• Estimated Primary Completion Date: June 20, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, France, Italy, Portugal, United Kingdom

Administrative Information

• NCT Number: NCT03229252
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Spyryx Biosciences, Inc.
• Study Sponsor: Spyryx Biosciences, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Spyryx Biosciences, Inc.
• Verification Date: May 2019