Safety and Efficacy of Varying Regimens of CANDIN for Tre... | NCT02393417

NCT02393417

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1	Experimental	0.3 mL of CANDIN administered intralesionally in the largest common wart	Biological: CANDIN
Cohort 2	Experimental	0.5 mL of CANDIN administered intralesionally in the largest common wart	Biological: CANDIN
Cohort 3	Experimental	0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)	Biological: CANDIN
Pooled Placebo	Placebo Comparator	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
CANDIN	Biological	Candida albicans Skin Test Antigen for Cellular Hypersensitivity	Cohort 1 Cohort 2 Cohort 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit	Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart	45 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit	Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart	45 weeks
Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit

Other Outcomes

Measure	Description	Time Frame
Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart	Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart	45 weeks
Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men or women between the ages of 18 and 65 years inclusively at time of consent
Subjects presenting with 3 to 20 injectable common warts (verruca vulgaris) for at least 12 weeks at the time of the Baseline Visit
Subject's common warts for injection must measure between 3 and 20 mm at Baseline Visit and be located on hands, feet (excluding soles), limbs, and/or trunk. Flat, plantar, facial, periungual, genital warts or warts in region of pre-existing inflammatory condition are excluded from injection
Subjects enrolled into Cohort 3 must have common warts for injection in at least 2 different anatomical regions defined as: left arm, right arm, left hand, right hand, left leg, right leg, left foot (excluding sole), right foot (excluding sole) and torso
Subject, male or female is willing to use effective contraceptive method for at least 30 days before the Baseline Visit and at least 30 days after the last study drug administration unless not of childbearing potential as defined as post-menopausal for at least 2 years (females) or surgically sterile (tubal ligation, oophorectomy, or hysterectomy for females, and vasectomy for males). The only contraceptive use exceptions would be individuals in exclusive same sex partnerships and individuals who agree to remain non-sexually active for the duration of the study. Acceptable contraceptive methods for subjects include:
- Barrier methods, such as condom, sponge or diaphragm, combined with spermicide in foam, gel or cream;
- Hormonal contraception (oral, intramuscular, implant or transdermal which includes Depo-Provera, Evra and Nuvaring);
- Intrauterine device (IUD)
Mentally and legally capable of giving informed consent prior to any study related procedures

Exclusion Criteria:

Presence of systemic or localized diseases, conditions, or medications that could interfere with assessment of safety and efficacy or that compromise immune function including psoriasis
Subject has been diagnosed with diabetes mellitus
Subject has a history of keloid formation
Injectable common wart(s) located in areas with existing dermatologic conditions (such as psoriasis) or with an underlying inflammatory conditions (such as arthritic joints), or tattoos or implants/piercing/hardware or marking that may conceal responses or reactions are excluded from injection
Existing/planned pregnancy, childbirth in the past six months prior to the Baseline Visit, or breast feeding, or plan on donating eggs or sperm during the study and in the month following the last injection
Treatment of warts with liquid nitrogen, carbon dioxide, electrodessication, laser, surgery, simple occlusion (e.g. duct tape) salicylic or related acids, OTC treatments, cantharidin, or other treatments within 4 weeks of the Baseline Visit
Treatment with immunotherapy (DPCP, DNCB or other), imiquimod, 5-fluorouracil, bleomycin, podophyllin or any other wart immunotherapy or treatment designed to stimulate immune response (except for treatments already listed in exclusion criterion 6) within 12 weeks of the Baseline Visit
Recalcitrant warts defined as those not successfully treated by 5 or more treatments (excluding OTC treatments)
Abnormal (low < 5 mm or high >25 mm) baseline result to the Delayed Type Hypersensitivity (DTH) test
Subject has a condition or treatment resulting in being immunocompromised
Systemic treatment (such as oral or injected) with cimetidine, zinc supplements at a dose higher than 20 mg of elemental zinc daily or an immunosuppressive drug (such as: azathioprine, 6-mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, systemic steroids, etc.) within 12 weeks of the Baseline Visit
Subject has used any investigational agent within 30 days prior to the Baseline Visit or within 5 half-lives of that investigational agent prior to the Baseline Visit (whichever is longer)
Previous treatment of warts with any type of intralesional injection with candida extract (including CANDIN)

Contacts/Locations Module

Name	Affiliation	Role
Thomas Carpenter, DVM, PhD	Nielsen BioSciences, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Johnson Dermatology		Fort Smith	Arkansas	72916	United States
Northwest Arkansas Clinical Trials Center PLLC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21173332	Result	Kim KH, Horn TD, Pharis J, Kincannon J, Jones R, O'Bryan K, Myers J, Nakagawa M. Phase 1 clinical trial of intralesional injection of Candida antigen for the treatment of warts. Arch Dermatol. 2010 Dec;146(12):1431-3. doi: 10.1001/archdermatol.2010.350. No abstract available.
40155509	Derived	Smith SR, Esch RE, Nielsen HS, Johnson SM. Randomized Phase IIa Trial of Purified Candida Antigen for Common Warts: Evaluating the Safety and Efficacy Across Multiple Dosing Regimens. Dermatol Ther (Heidelb). 2025 May;15(5):1135-1152. doi: 10.1007/s13555-025-01387-1. Epub 2025 Mar 29.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
FG001	Cohort 1

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 6, 2016	Apr 9, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

mITT- modified Intent to Treat population consisted of subjects that received at least one post baseline measurement of the primary wart(s).

Arm/Group Information

ID	Title	Description
BG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
BG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
BG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
BG003	Cohort 3	0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00034.7(18 to 65) BG00135.6(19 to 63) BG00233.5(18 to 62) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00016 BG00117 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0015 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00043 BG00144 BG002

Response (size of induration) to CANDIN injection during screening

CANDIN is currently marketed in the US and was used as indicated in this study as a recall antigen for detecting delayed-type hypersensitivity (DTH) following intradermal injection of 0.1 mL.

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG0009.95± 4.116 BG001

Body Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00093.91± 28.165 BG00190.30± 22.753 BG002

Body Mass Index

Mean

Standard Deviation

kg/m2

Title

Denominators

Categories

Title	Measurements
	BG00030.75± 8.812 BG00129.11± 6.291 BG002

Location of Common Warts

Number

each

Title

Denominators

Categories

Left Hand

Title	Measurements
	BG00029 BG00121 BG002

Area of Primary Injected Wart

Mean

Full Range

mm^2

Title

Denominators

Categories

Title	Measurements
	BG00032.19(9.4 to 233.3) BG00141.47(7.1 to 238.8) BG002

Age of Primary Injected Wart(s)

Mean

Full Range

weeks

Title

Denominators

Categories

Title	Measurements
	BG000228.9(12 to 1560) BG001202.0(14 to 1040) BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit

Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart

Modified Intent to Treat (mITT) - subjects that received at least one post baseline measurement of the primary wart(s)

Posted

Count of Participants

Participants

45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG003	Cohort 3	0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Units	Counts
Participants	OG00043 OG00144 OG00239 OG003

Title

Denominators

Categories

Title	Measurements
	OG00016 OG00129 OG00231 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		0.0329		Risk Ratio (RR)	1.5706			2-Sided	95	1.0184	2.4223					Superiority
OG000 OG002		Cochran-Mantel-Haenszel		0.0007

Secondary

Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit

Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart

mITT - Subjects that received at least one post baseline measurement of the primary wart(s)

Posted

Count of Participants

Participants

45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG003	Cohort 3

Secondary

Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit

Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart

mITT - Subjects that received at least one post baseline measurement of the primary wart(s)

Posted

Count of Participants

Participants

4 month follow up visit at 45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG003	Cohort 3

Secondary

Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s)

Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart

mITT. Subjects that received at least one post baseline measurement of the primary wart(s). Cohort 3 values represent resolution of largest primary wart

Posted

Median

95% Confidence Interval

injection visits

45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG003	Cohort 3

Secondary

Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s)

mITT - Subjects that received at least one post baseline measurement of the primary wart(s)

Posted

Median

95% Confidence Interval

injection visits

45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG003	Cohort 3	0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Secondary

Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts

mITT - Subjects that received at least on post baseline measurement of the primary wart(s)

Posted

Median

95% Confidence Interval

injection visits

45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG003	Cohort 3	0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Secondary

Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s)

Scarring at any visit, many reports were transient being noted at only one or two visits and noted as resolving during the course of the study

mITT - Subjects that received at least one post baseline measurement of the primary wart(s)

Posted

Count of Participants

Participants

45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG003	Cohort 3

Secondary

Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s)

Only mITT subjects with complete resolution of warts included in this endpoint

Posted

Count of Participants

Participants

45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG003	Cohort 3	0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Secondary

Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%

Safety Population- All randomized subjects who received at least one intralesional dose of study medication. Subjects experiencing multiple types of reactions were counted once for each type, but only once across all reactions.

Posted

Number

participants

45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG003	Cohort 3	0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Other Pre-specified

Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart

Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart

mITT- Subjects that received at least one post baseline measurement of the primary wart(s)

Posted

Number

number of warts resolved

45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG003	Cohort 3

Other Pre-specified

Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit.

mITT - subjects that received at least one post baseline measurement of the primary wart(s)

Posted

Number

wart recurrences

45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG003	Cohort 3	0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Other Pre-specified

Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History

Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart

mITT- Subjects that received at least one post baseline measurement of the primary wart(s). A subject may belong to more than one prior treatment types. As defined in the Statistical Analysis Plan, Cohorts 1 and 3 were combined for this exploratory endpoint (0.3 mL injected into each wart)

Posted

Count of Participants

Participants

45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1 and Cohort 3	0.3 mL of CANDIN administered intralesionally in the largest common wart (Cohort 1) and multiple common warts (Cohort 3) CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Other Pre-specified

The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts

mITT - Subjects that received at least one post baseline measurement of the primary wart(s). A subject may belong to more than one prior treatment types. As defined in the Statistical Analysis Plan, Cohorts 1 and 3 were combined for this exploratory endpoint (0.3 mL injected into each wart)

Posted

Number

Number of warts

45 weeks

ID	Title	Description
OG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)
OG001	Cohort 1 and Cohort 3	0.3 mL of CANDIN administered intralesionally in the largest common wart (Cohort 1) and multiple common warts (Cohort 3) CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pooled Placebo	0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)	43	0	43	32	43
EG001	Cohort 1	0.3 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity	45	0	45	33	45
EG002	Cohort 2	0.5 mL of CANDIN administered intralesionally in the largest common wart CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity	40	2	40	34	40
EG003	Cohort 3	0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity	41	1	41	33	41

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancreatitis, Acute	Gastrointestinal disorders	MeDRA 17.0	Systematic Assessment	EG0000 affected43 at risk EG0010 affected45 at risk EG0020 affected40 at risk EG0031 events1 affected41 at risk
Brain Abcess	Infections and infestations	MeDRA 17.0	Systematic Assessment	EG0000 affected43 at risk EG0010 affected45 at risk EG0021 events1 affected40 at risk EG003
Mediastinal Abcess	Infections and infestations	MeDRA 17.0	Systematic Assessment	EG0000 affected43 at risk EG0010 affected45 at risk EG0021 events1 affected40 at risk EG003
Pleuritic Pain	Respiratory, thoracic and mediastinal disorders	MeDRA 17.0	Systematic Assessment	EG0000 affected43 at risk EG0010 affected45 at risk EG0021 events1 affected40 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MeDRA 17.0	Systematic Assessment	EG00016 affected43 at risk EG00115 affected45 at risk EG00215 affected40 at risk EG00323 affected41 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MeDRA 17.0	Systematic Assessment	EG0009 affected43 at risk EG00114 affected45 at risk EG00214 affected40 at risk EG003
Fatigue	General disorders	MeDRA 17.0	Systematic Assessment	EG00015 affected43 at risk EG00112 affected45 at risk EG00214 affected40 at risk EG003
Diarrhoea	Gastrointestinal disorders	MeDRA 17.0	Systematic Assessment	EG0007 affected43 at risk EG00113 affected45 at risk EG0029 affected40 at risk EG003
Nausea	Gastrointestinal disorders	MeDRA 17.0	Systematic Assessment	EG0003 affected43 at risk EG0016 affected45 at risk EG0029 affected40 at risk EG003
Influenza	Infections and infestations	MeDRA 17.0	Systematic Assessment	EG0009 affected43 at risk EG0014 affected45 at risk EG0026 affected40 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MeDRA 17.0	Systematic Assessment	EG0002 affected43 at risk EG0012 affected45 at risk EG0026 affected40 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MeDRA 17.0	Systematic Assessment	EG0002 affected43 at risk EG0012 affected45 at risk EG0022 affected40 at risk EG003
Influenza Like Illness	General disorders	MeDRA 17.0	Systematic Assessment	EG0002 affected43 at risk EG0015 affected45 at risk EG0021 affected40 at risk EG003
Vomiting	Gastrointestinal disorders	MeDRA 17.0	Systematic Assessment	EG0000 affected43 at risk EG0011 affected45 at risk EG0024 affected40 at risk EG003
Sinusitis	Infections and infestations	MeDRA 17.0	Systematic Assessment	EG0001 affected43 at risk EG0011 affected45 at risk EG0022 affected40 at risk EG003
Nasopharyngitis	Infections and infestations	MeDRA 17.0	Systematic Assessment	EG0001 affected43 at risk EG0011 affected45 at risk EG0023 affected40 at risk EG003
Pyrexia	General disorders	MeDRA 17.0	Systematic Assessment	EG0003 affected43 at risk EG0010 affected45 at risk EG0022 affected40 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MeDRA 17.0	Systematic Assessment	EG0003 affected43 at risk EG0011 affected45 at risk EG0022 affected40 at risk EG003
Urinary Tract Infection	Infections and infestations	MeDRA 17.0	Systematic Assessment	EG0002 affected43 at risk EG0011 affected45 at risk EG0022 affected40 at risk EG003
Migraine	Nervous system disorders	MeDRA 17.0	Systematic Assessment	EG0000 affected43 at risk EG0011 affected45 at risk EG0022 affected40 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MeDRA 17.0	Systematic Assessment	EG0001 affected43 at risk EG0010 affected45 at risk EG0022 affected40 at risk EG003
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MeDRA 17.0	Systematic Assessment	EG0000 affected43 at risk EG0010 affected45 at risk EG0022 affected40 at risk EG003

ID	Term
D014860	Warts

Ancestor Terms

ID	Term
D030361	Papillomavirus Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D017193	Skin Diseases, Viral
D014412	Tumor Virus Infections
D012874	Skin Diseases, Infectious
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

BG00327.66(7.1 to 92.3)

BG00434.68(7.1 to 238.8)

BG003196.8(12 to 670)

BG004201.3(12 to 1560)

0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)

CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Units	Counts
Participants	OG0002 OG00126 OG0027