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SPL84 for Cystic Fibrosis
Phase 2
Recruiting
Research Sponsored by SpliSense Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of CF and two CF causing mutations; 3849+10 Kb C->T mutation on one allele in the CFTR gene (homozygote or compound heterozygote). Source documentation from a certified genetic laboratory is required.
Non-smokers or vapers for at least 180 days (6 months) prior to screening, per participant report.
Must not have
Documented coronavirus disease (COVID-19) infection within 4 weeks prior to dosing.
Use of any investigational drug (other than SPL84) or device within 30 days of first dose with study intervention.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 87
Summary
This trial aims to determine if the drug SPL84 is safe and effective for treating cystic fibrosis (CF) in adult patients, specifically those with a certain mutation. Participants will inhale the drug
Who is the study for?
Adults with cystic fibrosis can join this trial. They'll use an inhaler to take SPL84 or a placebo weekly for over two months and visit the clinic about 14 times in that period. The study will check if they have a specific CF mutation.
What is being tested?
The trial is testing SPL84, a new drug for cystic fibrosis, against a placebo (a substance with no active drug). It aims to determine the safety of multiple doses and how well it treats CF when taken by inhalation.
What are the potential side effects?
Specific side effects are not listed, but generally, participants may experience reactions related to inhaling medication such as coughing, throat irritation or potentially other symptoms which will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have cystic fibrosis with a specific genetic mutation.
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I have not smoked or used vaping products for at least 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had COVID-19 within the last 4 weeks.
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I haven't used any experimental drugs or devices in the last 30 days.
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I haven't started any new treatments for an infection or illness in the last 14 days.
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I have serious liver disease with cirrhosis or high blood pressure in the liver.
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I have had an organ transplant.
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I have not used systemic steroids for 3 months in a row or in the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 87
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 87
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal electrocardiogram (ECG) parameters
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal immunogenicity results
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal physical examination findings
+3 moreSecondary study objectives
Preliminary efficacy of SPL84 as assessed by change from baseline in Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score
Preliminary efficacy of SPL84 as assessed by change from baseline in percent predicted FEV1
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: SPL84Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
SpliSense Ltd.Lead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
32 Patients Enrolled for Cystic Fibrosis