Efficacy and Tolerability of Topical LFX453 for External Genital Warts

Phase 2

Completed

• Conditions: External Genital Warts
• Interventions: Drug: Investigational Treatment; Drug: Aldara

• Registration Number: NCT02482428
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The LFX453X2202 study tested the investigational drug LFX453 against placebo for safety, tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an additional open label arm using imiquimod 5%.

During the study the patients received either LFX453, placebo or active comparator and the tolerability and safety was assessed continuously through local tolerability assessments and adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken for safety, pharmacokinetics (PK), and biomarkers.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-12
• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-26
• Primary Completion: 2016-05-31
• Study Completion: 2016-05-31
• Results First Submitted: 2017-05-31
• Results First Submitted QC: 2017-06-22
• Results First Posted: 2017-06-23
• Status Verified: 2019-03
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 88

Inclusion Criteria

• Signed informed consent
• Circumcised male 18-60 years
• Clinical diagnosis of external genital warts
• Agree to remain abstinent or to use condoms during intercourse for the duration of the study
• Agree to digital photographs of treated area

Exclusion Criteria

• Any treatment of genital warts within one month of treatment start
• HPV vaccination
• presence of warts larger than 200 mm2
• Genital herpes within one month of treatment start
• History of Bowenoid papulosis
• significant illness within 2 weeks of treatment start
• use of other investigational drugs
• known hypersensitivity to study drugs or constituents
• history of ECG abnormalities
• History of significant heart conditions
• Impaired renal function
• Abnormal liver function
• History of immunodeficiency disease
• Drug or alcohol abuse
• Immunosuppressive therapies
• Malignancies in the past 5 years
• hypertrophic scarring

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle to NMC	Investigational Treatment	Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
Vehicle to LCC	Investigational Treatment	Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
LFX453 0.1% NMC	Investigational Treatment	LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
Aldara	Aldara	Aldara 5% cream 3 applications per week for a maximum of 16 weeks
LLFX453 0.15% LCC	Investigational Treatment	LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks

Primary Outcome Measures

Name	Time	Method
Complete Clearance of Disease at Week 14	Week 14	Number of participants achieving complete clearance of genital warts at Week 14
Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 30 Weeks	30 weeks	Number of participants with at least one AE/SAE in the category up to 30 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants That Had Partial Clearance Rate of at Least 75 Percent Reduction in External Genital Wart (EGW)s Count at End of Treatment (EOT) Week 12 or 16	End of Treatment (EOT) Week 12 or Week 16	Number of Participants that had partial clearance rate of at least 75 percent reduction in External Genital Wart (EGW)s count at end of treatment (EOT) Week 12 or 16

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Arlington Heights, Illinois, United States