A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.

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) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005230-30-GB

Enrollment

Registered

2017-05-03

Start date

2017-07-14

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Product Name: SPX-101 Pharmaceutical Form: Inhalation solution INN or Proposed INN: SPX-101 Current Sponsor code: SPX-101 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Ability to provide written, personally signed, and dated informed consent - Ability to self-administer the investigational product - Diagnosis of cystic fibrosis as determined by the 2008 Cystic Fibrosis Foundation Consensus Guidelines - Percent predicted forced expiratory volume in 1 second (ppFEV1) between 40.0% and 80.0% for cohort 1 and between 50.0% and 80% for cohort 2 - Stable CF lung disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - BMI < 18 kg/m2 - Use of a Cystic fibrosis transmembrane conductance regulator (CFTR) corrector or potentiator during the study or within 60 days before screening - The presence of significant and unstable comorbidities within 28 days before screening

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of SPX-101 in subjects with CF;Secondary Objective: - To evaluate the safety and tolerability of SPX-101 in subjects with CF - To assess the extent of systemic exposure of SPX-101 in a subset of subjects;Primary end point(s): The change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1) ;Timepoint(s) of evaluation of this end point: Week 4	—

Measure

Time frame

Main Objective: To evaluate the efficacy of SPX-101 in subjects with CF;Secondary Objective: - To evaluate the safety and tolerability of SPX-101 in subjects with CF - To assess the extent of systemic exposure of SPX-101 in a subset of subjects;Primary end point(s): The change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1) ;Timepoint(s) of evaluation of this end point: Week 4

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Secondary

Measure	Time frame
Secondary end point(s): - The change from baseline in ppFEV1 - The change from baseline in Forced expiratory volume in one second (FEV1), Forced Vital Capacity (FVC) and percent predicted forced vital capacity (ppFVC) - The change from Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) ;Timepoint(s) of evaluation of this end point: ppFEV1 at weeks 1 and 2 FEV1, FVC and ppFVC at weeks 1, 2, and 4 CFQ-R at week 4	—

Measure

Time frame

Secondary end point(s): - The change from baseline in ppFEV1 - The change from baseline in Forced expiratory volume in one second (FEV1), Forced Vital Capacity (FVC) and percent predicted forced vital capacity (ppFVC) - The change from Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) ;Timepoint(s) of evaluation of this end point: ppFEV1 at weeks 1 and 2 FEV1, FVC and ppFVC at weeks 1, 2, and 4 CFQ-R at week 4

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Countries

Australia, Canada, France, Italy, Portugal, United Kingdom

Contacts

Public ContactClinical Development Operations

Spyryx Biosciences, Inc.

contact@spyryxbio.com+1919899 9399

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026