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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo Inhalation Solution
SPX-101
Sponsored by
Spyryx Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of cystic fibrosis
  • ppFEV1 (percent predicted FEV1) 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

Sites / Locations

  • University of Calgary Heritage Medical Research Center
  • Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa
  • Saint Michael's Hospital
  • Centre Hospitalier Universitaire Brest
  • CHU de Rouen
  • CHU de Montpellier
  • CHU de Angers
  • Hopital Pasteur
  • Hospices Civils de Lyon (HCL)
  • Assistance Publique-Hôpitaux de Paris Hôpital Cochin
  • Istituto Giannina Gaslini Ospedale Pediatrico
  • Hospital de Santa Maria
  • Belfast Health and Social Care Trust
  • Heart of England NHS Foundation Trust
  • University Hospitals Bristol NHS Foundation Trust
  • Western General Hospital - NHS Lothian
  • Royal Devon and Exeter NHS Foundation Trust
  • NHS Greater Glasgow and Clyde
  • The Leeds Teaching Hospitals NHS Trust
  • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • Barts Health NHS Trust Saint Bartholomews Hospital
  • Royal Brompton and Harefield NHS Foundation Trust
  • University Hospital of South Manchester NHS Foundation Trust
  • Newcastle Upon Tyne Hospitals
  • Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

SPX-101 Low Dose

SPX-101 High Dose

Arm Description

Placebo Inhalation solution twice daily for 28 days.

Inhalation solution twice daily for 28 days.

Inhalation solution twice daily for 28 days.

Outcomes

Primary Outcome Measures

Change in Percent Predicted FEV1

Secondary Outcome Measures

Number of Participants With Adverse Events
Change From Baseline Through Day 28 in Clinical Laboratory Tests
Chemistry, Hematology, Urinalysis

Full Information

First Posted
July 14, 2017
Last Updated
December 6, 2019
Sponsor
Spyryx Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03229252
Brief Title
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Acronym
(HOPE-1)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spyryx Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Inhalation solution twice daily for 28 days.
Arm Title
SPX-101 Low Dose
Arm Type
Experimental
Arm Description
Inhalation solution twice daily for 28 days.
Arm Title
SPX-101 High Dose
Arm Type
Experimental
Arm Description
Inhalation solution twice daily for 28 days.
Intervention Type
Drug
Intervention Name(s)
Placebo Inhalation Solution
Intervention Description
Normal Saline Inhalation Solution
Intervention Type
Drug
Intervention Name(s)
SPX-101
Intervention Description
SPX-101 Inhalation Solution
Primary Outcome Measure Information:
Title
Change in Percent Predicted FEV1
Time Frame
Baseline and Day 28
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
Day 1 through Day 28
Title
Change From Baseline Through Day 28 in Clinical Laboratory Tests
Description
Chemistry, Hematology, Urinalysis
Time Frame
Day 1 through Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of cystic fibrosis ppFEV1 (percent predicted FEV1) 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
Facility Information:
Facility Name
University of Calgary Heritage Medical Research Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Facility Name
Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Saint Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
Facility Name
Centre Hospitalier Universitaire Brest
City
Roscoff
State/Province
Bretagne
Country
France
Facility Name
CHU de Rouen
City
Rouen
State/Province
Haute-Normandie
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
State/Province
Languedoc-Roussillon
Country
France
Facility Name
CHU de Angers
City
Angers
State/Province
Pays De La Loire
Country
France
Facility Name
Hopital Pasteur
City
Nice
State/Province
Provence Alpes Cote D'azur
Country
France
Facility Name
Hospices Civils de Lyon (HCL)
City
Pierre Bénite
State/Province
Rhone-Alpes
Country
France
Facility Name
Assistance Publique-Hôpitaux de Paris Hôpital Cochin
City
Paris
Country
France
Facility Name
Istituto Giannina Gaslini Ospedale Pediatrico
City
Genoa
Country
Italy
Facility Name
Hospital de Santa Maria
City
Lisbon
Country
Portugal
Facility Name
Belfast Health and Social Care Trust
City
Belfast
Country
United Kingdom
Facility Name
Heart of England NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
Country
United Kingdom
Facility Name
Western General Hospital - NHS Lothian
City
Edinburgh
Country
United Kingdom
Facility Name
Royal Devon and Exeter NHS Foundation Trust
City
Exeter
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
Country
United Kingdom
Facility Name
The Leeds Teaching Hospitals NHS Trust
City
Leeds
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital NHS Foundation Trust
City
Liverpool
Country
United Kingdom
Facility Name
Barts Health NHS Trust Saint Bartholomews Hospital
City
London
Country
United Kingdom
Facility Name
Royal Brompton and Harefield NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
University Hospital of South Manchester NHS Foundation Trust
City
Manchester
Country
United Kingdom
Facility Name
Newcastle Upon Tyne Hospitals
City
Newcastle-upon-Tyne
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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