Efficacy and Tolerability of Topical LFX453 for External Genital Warts

NCT02482428 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CLFX453X2202
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

External Genital Warts

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Complete Clearance of Disease at Week 14

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

  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

  30 weeks

Secondary Outcomes (1)

• 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

Study Arms (5)

LFX453 0.1% NMC

EXPERIMENTAL

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

Drug: Investigational Treatment

LLFX453 0.15% LCC

EXPERIMENTAL

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

Drug: Investigational Treatment

Vehicle to NMC

PLACEBO COMPARATOR

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

Drug: Investigational Treatment

Vehicle to LCC

PLACEBO COMPARATOR

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

Drug: Investigational Treatment

Aldara

ACTIVE COMPARATOR

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

Drug: Aldara

Interventions

Investigational Treatment DRUG

Applied twice daily for up to 12 weeks

LFX453 0.1% NMC; LLFX453 0.15% LCC; Vehicle to LCC; Vehicle to NMC

Aldara DRUG

Applied 3 times a week for 16 weeks

Also known as: imiquimod

Aldara

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Arlington Heights, Illinois, 60005, United States

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Papillomavirus Infections; Condylomata Acuminata; Sexually Transmitted Diseases; Virus Diseases

Interventions

Therapies, Investigational; Imiquimod

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Communicable Diseases; Infections; DNA Virus Infections; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Warts; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 26, 2015
• Study Start: May 12, 2015
• Primary Completion: May 31, 2016
• Study Completion: May 31, 2016
• Last Updated: January 5, 2021
• Results First Posted: June 23, 2017

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)