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

Phase 2

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: SPX-101; Drug: Placebo Inhalation Solution

• Registration Number: NCT03229252
• Lead Sponsor: Spyryx Biosciences, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-25
• Study Start: 2017-08-01
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-20
• Results First Submitted: 2019-08-26
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-06
• Last Update Submitted: 2019-12-06
• Results First Posted: 2019-12-30
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPX-101 Low Dose	SPX-101	Inhalation solution twice daily for 28 days.
SPX-101 High Dose	SPX-101	Inhalation solution twice daily for 28 days.
Placebo	Placebo Inhalation Solution	Placebo Inhalation solution twice daily for 28 days.

Primary Outcome Measures

Name	Time	Method
Change in Percent Predicted FEV1	Baseline and Day 28

Secondary Outcome Measures

Name	Time	Method
Change From Baseline Through Day 28 in Clinical Laboratory Tests	Day 1 through Day 28	Chemistry, Hematology, Urinalysis
Number of Participants With Adverse Events	Day 1 through Day 28

Trial Locations

Locations (25)

Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa; 🇨🇦 Ottawa, Ontario, Canada

CHU de Rouen; 🇫🇷 Rouen, Haute-Normandie, France

CHU de Angers; 🇫🇷 Angers, Pays De La Loire, France

Hopital Pasteur; 🇫🇷 Nice, Provence Alpes Cote D'azur, France

Istituto Giannina Gaslini Ospedale Pediatrico; 🇮🇹 Genoa, Italy

Assistance Publique-Hôpitaux de Paris Hôpital Cochin; 🇫🇷 Paris, France

Heart of England NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Western General Hospital - NHS Lothian; 🇬🇧 Edinburgh, United Kingdom

Royal Devon and Exeter NHS Foundation Trust; 🇬🇧 Exeter, United Kingdom

The Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom

NHS Greater Glasgow and Clyde; 🇬🇧 Glasgow, United Kingdom

Barts Health NHS Trust Saint Bartholomews Hospital; 🇬🇧 London, United Kingdom

Newcastle Upon Tyne Hospitals; 🇬🇧 Newcastle-upon-Tyne, United Kingdom

CHU de Montpellier; 🇫🇷 Montpellier, Languedoc-Roussillon, France

Hospices Civils de Lyon (HCL); 🇫🇷 Pierre Bénite, Rhone-Alpes, France

University Hospitals Bristol NHS Foundation Trust; 🇬🇧 Bristol, United Kingdom

Liverpool Heart and Chest Hospital NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom

Royal Brompton and Harefield NHS Foundation Trust; 🇬🇧 London, United Kingdom

University Hospital of South Manchester NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Hospital de Santa Maria; 🇵🇹 Lisbon, Portugal

University of Calgary Heritage Medical Research Center; 🇨🇦 Calgary, Alberta, Canada

Centre Hospitalier Universitaire Brest; 🇫🇷 Roscoff, Bretagne, France

Saint Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Belfast Health and Social Care Trust; 🇬🇧 Belfast, United Kingdom