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Efficacy and Tolerability of Topical LFX453 for External Genital Warts

Primary Purpose

External Genital Warts

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Investigational Treatment

Aldara

About this trial

This is an interventional treatment trial for External Genital Warts focused on measuring human papilloma virus (HPV), Genital Warts, Sexually transmitted disease (STD), viral disease

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

LFX453 0.1% NMC

LLFX453 0.15% LCC

Vehicle to NMC

Vehicle to LCC

Aldara

Arm Description

LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks

LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks

Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks

Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks

Aldara 5% cream 3 applications per week for a maximum of 16 weeks

Outcomes

Primary Outcome Measures

Complete Clearance of Disease at 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

Number of participants with at least one AE/SAE in the category up to 30 weeks

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02482428

First Posted

May 26, 2015

Last Updated

December 9, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02482428

Brief Title

Efficacy and Tolerability of Topical LFX453 for External Genital Warts

Official Title

A Randomized, Vehicle Controlled, Active Comparator, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of Topical LFX453 Formulations in Patients With External Genital Warts (EGWs)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

May 12, 2015 (Actual)

Primary Completion Date

May 31, 2016 (Actual)

Study Completion Date

May 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

External Genital Warts

Keywords

human papilloma virus (HPV), Genital Warts, Sexually transmitted disease (STD), viral disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LFX453 0.1% NMC

Arm Type

Experimental

Arm Description

LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks

Arm Title

LLFX453 0.15% LCC

Arm Type

Experimental

Arm Description

LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks

Arm Title

Vehicle to NMC

Arm Type

Placebo Comparator

Arm Description

Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks

Arm Title

Vehicle to LCC

Arm Type

Placebo Comparator

Arm Description

Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks

Arm Title

Aldara

Arm Type

Active Comparator

Arm Description

Aldara 5% cream 3 applications per week for a maximum of 16 weeks

Intervention Type

Drug

Intervention Name(s)

Investigational Treatment

Intervention Description

Applied twice daily for up to 12 weeks

Intervention Type

Drug

Intervention Name(s)

Aldara

Other Intervention Name(s)

imiquimod

Intervention Description

Applied 3 times a week for 16 weeks

Primary Outcome Measure Information:

Title

Complete Clearance of Disease at Week 14

Description

Number of participants achieving complete clearance of genital warts at Week 14

Time Frame

Week 14

Title

Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 30 Weeks

Description

Number of participants with at least one AE/SAE in the category up to 30 weeks

Time Frame

30 weeks

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

End of Treatment (EOT) Week 12 or Week 16

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=186

Description

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Learn more about this trial

Efficacy and Tolerability of Topical LFX453 for External Genital Warts

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