Clinical Trial Results:
A phase 2, randomized, vehicle-controlled, double-blind study to explore the efficacy, pharmacodynamics and safety of topical ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide in HPV-induced genital lesions of immunocompromised and immunocompetent patients.
|
Summary
|
|
EudraCT number |
2016-000870-39 |
Trial protocol |
NL |
Global end of trial date |
30 Oct 2018
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
24 Sep 2022
|
First version publication date |
24 Sep 2022
|
Other versions |
|
Summary report(s) |
M3. CHDR1607_CSR Summary_6Jun2019 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
CHDR1607
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
ToetsingOnline: NL57025.056.17 | ||
|
Sponsors
|
|||
Sponsor organisation name |
Cutanea Life Sciences
|
||
Sponsor organisation address |
1500 Liberty Ridge Drive, Suite 3000, Wayne, United States, PA 19087
|
||
Public contact |
J. Burggraaf, Centre for Human Drug Research, +31 715246400, clintrials@chdr.nl
|
||
Scientific contact |
J. Burggraaf, Centre for Human Drug Research, +31 715246400, clintrials@chdr.nl
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
06 Jun 2019
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
30 Oct 2018
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
30 Oct 2018
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
• To explore the pharmacodynamics of the ionic contra-viral therapy CLS003 in immunocompromised and immunocompetent patients with benign and premalignant HPV-induced genital lesions.
• To evaluate clinical efficacy of CLS003 compared to vehicle in immunocompromised and immunocompetent patients with benign and premalignant HPV-induced genital lesions
|
||
Protection of trial subjects |
CLS003 consists of a combination of the active substances digoxin and furosemide. The cardiac glycoside digoxin and the loop diuretic furosemide are currently market registered drugs for various indications e.g. heart failure / atrium fibrillation and hypertension, respectively. The formulations on the market comprise oral and parenteral route of administration leading to high systemic exposure to both drugs. Consequently, there is a vast amount of pre-clinical and clinical experience with these mechanisms of action. Therefore, drugs of this class can be administered safely to healthy volunteers and patients with a topical formulation. Potential beneficial effects on AGWs and vulvar HSIL are to be explored in this study. Therefore, providing the protocol is adhered to, careful observation and medical management will minimize any associated risk in this study.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Aug 2017
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Netherlands: 24
|
||
Worldwide total number of subjects |
24
|
||
EEA total number of subjects |
24
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
23
|
||
From 65 to 84 years |
1
|
||
85 years and over |
0
|
||
|
||||||||||
|
Recruitment
|
||||||||||
Recruitment details |
Patients will be enrolled into the study following satisfactory completion of a screening visit where eligibility for the study will be checked. Patients will be recruited via media advertisement and via referring gynaecologists and dermatologists. | |||||||||
|
Pre-assignment
|
||||||||||
Screening details |
Within 5 weeks prior to study baseline visit (Day 0), patients will undergo a medical screening. Screening will be performed in a fasting state (≥4 hours), and consists of medical history, physical examination, Fitzpatrick skin type classification, 12-lead ECG, vital signs, weight, height, heartrate, blood sampling and urinalysis. | |||||||||
|
Period 1
|
||||||||||
Period 1 title |
Overall trial (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Assessor, Data analyst | |||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
Active drugs | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
CLS003 - ICVT topical formulation containing digoxin (0.125%) and furosemide (0.125%)
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Gel
|
|||||||||
Routes of administration |
Topical
|
|||||||||
Dosage and administration details |
ICVT topical formulation containing digoxin (0.125% w/w) and furosemide (0.125%). 0.3mL of gel (approximately 200 mg) applied topically once daily for 6 weeks. (approximately 200 mg).
|
|||||||||
|
Arm title
|
Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Gel
|
|||||||||
Routes of administration |
Topical
|
|||||||||
Dosage and administration details |
Approximately 200 mg/ 0,3ml of vehicle will be applied on all visible lesions.
|
|||||||||
|
||||||||||
|
|||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||
Reporting group title |
Overall trial (overall period)
|
||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Active drugs
|
||
Reporting group description |
- | ||
Reporting group title |
Placebo
|
||
Reporting group description |
- | ||
|
||||||||||
End point title |
Wart count [1] | |||||||||
End point description |
||||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
The warts were counted at every study visit.
|
|||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: For results and analysis see attached document. |
||||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse events (AE) will be collected throughout the study, at every study visit.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Active drugs
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
