Neoplasms

All Conditions

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Head and Neck Neoplasms

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Vaccines

Cyclophosphamide

Immunomodulating Agents

Detox adjuvant

Immunologic Factors

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

pNGVL-4a-CRT/E7 (detox) DNA Vaccine (Dose 0.5 mg/dose) + Cyclophosphamide (200 mg/m2)

pNGVL-4a-CRT/E7 (detox) DNA Vaccine (Dose 1.0 mg/dose) + Cyclophosphamide (200 mg/m2)

pNGVL-4a-CRT/E7 (detox) DNA Vaccine (Dose 2.0 mg/dose) + Cyclophosphamide (200 mg/m2)

pNGVL-4a-CRT/E7 (detox) DNA Vaccine (Dose 4.0 mg/dose) + Cyclophosphamide (200 mg/m2)

Patients will receive intramuscular needle injections of pNGVL4a-CRT/E7 (detox) DNA vaccine using the TDS-IM device on Day 1, 22, and 43 for a total of three vaccinations per patient. One day prior to each DNA vaccination, the patient will receive a single low dose of 200 mg/m2 of cyclophosphamide intravenously. The DNA vaccine will be administered in a dose-escalating manner.

DNA Vaccine

A single low dose of 200 mg/m2 of cyclophosphamide (CTX) will be administered intravenously up to 24 hours (Day 0) prior to each DNA vaccination.

Joseph Califano, MD

This study will test the safety of an HPV DNA vaccine after it is injected into your muscle using an electroporation device (TriGridTM Delivery System made by Ichor Medical Systems), and will test the ability of the vaccine to help your body's immune system to recognize HPV-infected and associated cancer cells. In addition to giving the vaccine using an electroporation device, we are giving the vaccine in combination with an immunomodulatory agent to further enhance immune responses against HPV-infected and associated cancer cells.

Safety Study of HPV DNA Vaccine to Treat Head and Neck Cancer Patients

A Phase I Clinical Trial Assessing the Safety and Feasibility of Administration of pNGVL4a-CRT/E7(Detox) DNA Vaccine Using the Intramuscular TriGridTM Delivery System in Combination With Cyclophosphamide in HPV-16 Associated Head and Neck Cancer Patients

National Institute of Dental and Craniofacial Research (NIDCR)

Ichor Medical Systems Incorporated

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Skin and Connective Tissue Diseases

Skin Diseases

Communicable Diseases

Condylomata Acuminata

Virus Diseases

Papillomavirus Infections

Papilloma

Warts

Skin Diseases, Infectious

Skin Diseases, Viral

Disease Attributes

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Pharmaceutical Solutions

Cantharidin

Enzyme Inhibitors

For part A, VP-102 will be applied for 2 hours and removed. If selected as a dose regimen for Part B VP-102 will be applied for 2 hours and removed.In both parts, VP-102 is applied every 21 days for 4 treatments.

For part A, VP-102 will be applied for 6 hours and removed. If selected as a dose regimen for Part B VP-102 will be applied for 6 hours and removed. In both parts, VP-102 is applied every 21 days for 4 treatments.

For part A, VP-102 will be applied for 24 hours and removed. If selected as a dose regimen for Part B, VP-102 will be applied for 24 hours and removed. In both parts, VP-102 is applied every 21 days for 4 treatments.

For part A, VP-102 will be applied for 2-,6- or 24- hours and removed. Placebo is applied every 21 days for 4 treatments.

Part B, VP-102 will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part B, Placebo will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.

For part A, VP-102 will be applied for 24 hours and removed. If 24 hours is selected as a dose regimen for Part B, VP-102 will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part B, VP-Placebo will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments.

In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.

VP-102 and applicator

The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin

Placebo

Scott Guenthner, MD

This is a Phase 2, double-blind, placebo-controlled study to determine the dose regimen, safety, tolerability, and efficacy of VP-102 in subjects with External Genital Warts (EGW). This study is divided into two parts (Part A and Part B). Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups prior to progressing to enrollment in Part B. Part A \& B will enroll a approximately 108 subjects completing 4 treatment applications every 21 days and continuing with follow-up assessments at Day 84, 112 and 147.

This study is to determine the Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects with External Genital Warts. It is divided into two parts (Part A and Part B). The aim of Part A is to determine the two best treatment regimens for evaluation of safety and efficacy in Part B.In Part A, Study drug (VP-102 or placebo) will be administered once every 21 days for up to four applications. Enrollment will begin in Group 1, then proceed into Group 2, and lastly into Group 3. A safety review will be conducted to determine whether enrollment can be initiated into the next Group. An additional blinded safety review will be performed after all six subjects in Group 3 have completed the 48-hour Visit, in order to support dose selection for Part B (Safety and Efficacy). Part B of the study will begin enrollment only after the Sponsor has selected the two dose regimens from Part A. The study will remain blinded until completion of both parts of the study.

In Part A, up to 18 subjects will be randomized to VP-102 or placebo treatment with three different regimens. When Part B is open an additional \~90 subjects will be enrolled and randomized to VP-102 or placebo with two treatment regimens. Two of the treatment arms will be VP-102 Regimen 1 and VP-102 Regimen 2. The other two treatment arms will be placebo (Placebo Regimen 1 and Placebo Regimen 2), with corresponding durations of skin exposure matching those selected for VP-102 Regimen 1 and Regimen 2. As an example, if the regimens selected from Part A are the 2-hour and 6-hour applications of VP-102, then VP-102 Regimen 1 would be VP-102 treatment for 2-hours and VP-102 Regimen 2 would be VP-102 treatment for 6-hours. Likewise, Placebo Regimen 1 would be placebo treatment for 2 hours and Placebo Regimen 2 would be placebo treatment for 6-hours. Randomization of the four treatment arms (VP-102 Regimen 1:VP-102 Regimen 2:Placebo Regimen 1:Placebo Regimen 2) will be 3:3:2:2. In both Regimen 1 and Regimen 2, study drug will be administered to EGW once every 21 days for up to four applications. Subjects will be asked to remove the study drug at the designated time selected from the dose regimen findings in Part A of the study. Treatment will continue with a minimum of every 21 days, until complete clearance or a maximum of four treatment sessions. Safety assessments including recording of local skin reactions are conducted at each treatment visit and at follow up visits Day 84, 112, and 147.

The aim of Part A is to determine the two best treatment regimens for evaluation of safety and efficacy in Part B. Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups (n=6/group) that will enroll progressively.

Part B of the study will begin enrollment only after the Sponsor has selected the two dose regimens in Part A, which will be called VP-102 Regimen 1 and Regimen 2.Approximately 90 subjects will be enrolled and randomized to one of four treatment arms (two treatment regimens, each with VP-102 and Placebo). Randomization will be stratified by sex so that neither gender exceeds \~60% of any treatment arm. Two of the treatment arms will be VP-102 Regimen 1 and VP-102 Regimen 2. The other two treatment arms will be placebo (Placebo Regimen 1 and Placebo Regimen 2), with corresponding durations of skin exposure matching those selected for VP-102 Regimen 1 and Regimen 2.

A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts

A Phase 2, Double-Blind, Placebo-Controlled Study to Determine the Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects With External Genital Warts

Proportion of subjects exhibiting reduction of ≥ 1 treatable wart from baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Proportion of subjects who are clear at all three study visits, Study Day 84 (End of Treatment) Visit and remain clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study).

Change from baseline in total wart area (sum of individual warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Percent Change from baseline in the total wart area (sum of individual warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.

Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Proportion of subjects exhibiting 90% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Proportion of subjects exhibiting 75% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Number of warts present were recorded at each treatment visit as well as follow-up visits. For each post baseline treatment visit, the change in number of warts from baseline was calculated.

Percent Change from Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Instat Consulting, Inc.

Paidion Research, Inc.

BioClinica, Inc.

Verrica Pharmaceuticals Inc.

TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.

Data will be summarized for both Part B pooled with Part A for the applicable treatments.

Part B Pooled With Part A: VP-102 6-hour

Part B Pooled With Part A: Placebo 6-hour

Part B Pooled With Part A VP-102 24-hour

Part B Pooled With Part A: Placebo 24-hour

Part A: VP-102 2-hour

Data summarized for VP-102 2-hour group..

Part A: Placebo 2-hour

VP-102 will be applied for 2-hours and removed. VP-102 is applied every 21 days for 4 treatments.

VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part A: VP-102 6-hour

VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part A: VP-102 24-hour

Placebo will be applied for 2-,6- or 12-hours and removed. Placebo is applied every 21 days for 4 treatments.

Part A: Placebo

Part B: VP-102 6-hour

Placebo will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part B: 6-hour-Placebo

Part B: VP-102 24-hour

Placebo will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part B: 24-hour-Placebo

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Baseline number of treatable external genital warts

Due to logistical and/or scheduling difficulties related to the SARS-CoV-2 (coronavirus-19; COVID-19) pandemic during the course of the study, six subjects discontinued due to COVID-19 related reasons.

Susan Cutler, VP, Medical Affairs

Part B summary is pooled with its respective treatments from Part A.

Part B and A: Intent-to-Treat Population. Part B summary is pooled with its respective treatments from Part A.

Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.

Treatment Visit 2 - Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.

Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2: Yes, Complete Clearance

Treatment Visit 3: Yes, Complete Clearance

Treatment Visit 4: Yes, Complete Clearance

Study Day 84 EOT: Yes, Complete Clearance

F/U Visit Day 112: Yes, Complete Clearance

F/U Visit Day 147: Yes, Complete Clearance

Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.

Study Day84 EOT Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.

Study Day 84 EOT Visit Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2: Incidence of >=90% Clearance: YES

Treatment Visit 3: Incidence of >=90% Clearance: YES

Treatment Visit 4: Incidence of >=90% Clearance: YES

Study Day 84 EOT: Incidence of >=90% Clearance: YES

F/U Visit Day 112: Incidence of >=90% Clearance: YES

F/U Visit Day 147: Incidence of >=90% Clearance: YES

Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.

Study Day 84 (EOT) visit: Part B summary is pooled with its respective treatments from Part A.

Study Day 84 (EOT) Visit: Part B summary is pooled with its respective treatments from Part A.

Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.

Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2: Incidence of >=75% Clearance: YES

Treatment Visit 3: Incidence of >=75% Clearance: YES

Treatment Visit 4: Incidence of >=75% Clearance: YES

Study Day 84 EOT: Incidence of >=75% Clearance: YES

F/U Visit Day 112: Incidence of >=75% Clearance: YES

F/U Visit Day 147: Incidence of >=75% Clearance: YES

Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.

Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.

Treatment visit 2: Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 3: Degrees of freedom associated with the error term were computed using Kenward-Rogers method.

Treatment visit 4: Part B summary is pooled with its respective treatments from Part A.

Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.

Follow up day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2

Treatment Visit 3

Treatment Visit 4

Study Day 84 EOT Visit

Follow up Day 112

Follow-up Visit Day 147 EOS

Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.

Follow up Day 112: Part B summary is pooled with its respective treatments from Part A.

Follow up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.

Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.

Study Day 84 End of Treatment Visit

Follow up Visit Day 147 End of Study

Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Study Day 84 EOT: Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.

F/U Visit Day 112

F/U Visit Day 147 EOS

Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study)

Study Day 84 (EOT: Part B summary is pooled with its respective treatments from Part A.

Study Day 112 (EOT: Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.

Study Day 84 (EOT)

Follow-up Day 112

Follow-up Visit Day 147 (EOS)

Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Follow-up Day 147 (EOS)

Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.

Part A: VP-102 6-hour Group

Part A: VP-102 24-hour Group

This includes 3 subjects that received placebo (1 each for the 2-hour; 6-hour and 24-hour)

VP-102 and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.

Placebo and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of HPV DNA Vaccine to Treat Head and Neck Cancer Patients	NCT01493154	Head and Neck C...	DNA Vaccine Cyclophosphamid...	18 Years - 75 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts	NCT03981822	Condylomata Acu... Papillomavirus ... Skin Diseases, ... Skin Diseases, ... Skin Diseases Sexually Transm... Sexually Transm... Warts	VP-102 and appl... Placebo	18 Years -	Verrica Pharmaceuticals Inc.
HIV Indicator Diseases in Hospital and Primary Care	NCT05225493	HIV Infections Primary Health ... Acquired Immuno... Sexually Transm... Herpes Zoster Dermatitis, Seb... Pneumonia Infectious Mono... Psoriasis Candida Infecti... Lymphadenopathy Uterine Cervica... Weight Loss Diarrhea Chroni... Leukopenia Thrombocytopeni... AIDS Defining I... HIV Indicator C...	Peer to peer fe... HIV rapid test	18 Years -	Erasmus Medical Center
Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population	NCT01598779	Condylomata Acu...		15 Years - 45 Years	University of Buenos Aires
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts	NCT03981822	Condylomata Acu... Papillomavirus ... Skin Diseases, ... Skin Diseases, ... Skin Diseases Sexually Transm... Sexually Transm... Warts	VP-102 and appl... Placebo	18 Years -	Verrica Pharmaceuticals Inc.
Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population	NCT01598779	Condylomata Acu...		15 Years - 45 Years	University of Buenos Aires
Safety Study of HPV DNA Vaccine to Treat Head and Neck Cancer Patients	NCT01493154	Head and Neck C...	DNA Vaccine Cyclophosphamid...	18 Years - 75 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts	NCT03981822	Condylomata Acu... Papillomavirus ... Skin Diseases, ... Skin Diseases, ... Skin Diseases Sexually Transm... Sexually Transm... Warts	VP-102 and appl... Placebo	18 Years -	Verrica Pharmaceuticals Inc.

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