Efficacy and Tolerability of Topical LFX453 for External Genital Warts

Novartis Pharmaceuticals88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

External Genital Warts

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Complete Clearance of Disease at Week 14

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

Time frame: 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

Time frame: 30 weeks

Secondary Outcomes

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

Time frame: End of Treatment (EOT) Week 12 or Week 16