Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis

• Sponsor: Incyte Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00617994
• Collaborator: (none)
• Enrollment: 25
• Locations: 4
• Arms: 3
• Actual Duration (Months): 21
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: Ruxolitinib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label, Safety, Tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD) and Preliminary Efficacy Study of Ruxolitinib When Applied to Patients With Plaque Psoriasis Involving 2 - 20% Body Surface Area (BSA).
• Actual Study Start Date: Aug 31, 2007
• Actual Primary Completion Date: Apr 30, 2009
• Actual Study Completion Date: May 31, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA.	Drug: Ruxolitinib; Ruxolitinib 1.5% cream BID for 28 days; Other Names: INCB018424
Experimental: Group B Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1.	Drug: Ruxolitinib; Ruxolitinib 1.5% cream BID for 28 days; Other Names: INCB018424
Experimental: Group C Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.	Drug: Ruxolitinib; Ruxolitinib 1.5% cream BID for 28 days; Other Names: INCB018424

Outcome Measures

Primary Outcome Measures

1. Number of Treatment of Emergent Adverse Events [Approximately 3 months]

   Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

2. Pharmacokinetics Parameter : Skin Flux of INCB018424 [Days 1, 4, 8, 15, 22, and 28-30]

   The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.

3. Pharmacokinetics Parameter: Bioavailability of INCB018424 [Approximately one month: Days 1, 4, 8, 15, 22, and 28]

   The INCB018424 bioavailability was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.

4. Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424 [Approximately one month: Days 1, 4, 8, 15, 22, and 28]

   All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.

Secondary Outcome Measures

1. Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline [Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)]

   Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12.

2. Mean Change in Psoriatic Lesion Area [Days 1 and 28]

   The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area.

3. Mean Change in Physicians Global Assessment Score [Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later]

   The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments. Note that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have psoriatic lesions measuring protocol specific BSA

Exclusion Criteria:

• Lesions solely involving the palms of the hands, the soles of the feet, the intertriginious areas, the scalp or the face

• Pustular psoriasis or erythroderma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fridley	Minnesota	United States	55432
2		Rochester	New York	United States	14623
3		Austin	Texas	United States	78759
4		College Station	Texas	United States	77840

Sponsors and Collaborators

• Incyte Corporation

Investigators

• Study Director: William Williams, MD, Incyte Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT00617994
• Other Study ID Numbers: INCB 18424-202
• First Posted: Feb 18, 2008
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Incyte Corporation: psoriasis
• Additional relevant MeSH terms: Psoriasis

Study Results

Participant Flow

Recruitment Details	The study was conducted at 6 study centers in the United States from 08 November 2007 to 13 April 2009. This study is completed.
Pre-assignment Detail	A total of 25 participants with active but stable plaque psoriasis were enrolled in the dose-escalation study.

Arm/Group Title	Cohort A	Cohort B	Cohort C	Cohort D	Cohort E
Arm/Group Description	2% to 7% of BSA treated BID with INCB018424 1.5% cream	8% to 13% of BSA treated BID with INCB018424 1.5% cream	14% to 20% of BSA treated QD with INCB018424 1.5% cream	14% to 20% of BSA treated BID with INCB018424 1.0% cream	14% to 20% of BSA treated BID with INCB018424 1.5% cream
Period Title: Overall Study
STARTED	5	5	5	5	5
COMPLETED	5	5	5	5	5
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Cohort A	Cohort B	Cohort C	Cohort D	Cohort E	Total
Arm/Group Description	2% to 7% of BSA treated BID with INCB018424 1.5% cream	8% to 13% of BSA treated BID with INCB018424 1.5% cream	14% to 20% of BSA treated QD with INCB018424 1.5% cream	14% to 20% of BSA treated BID with INCB018424 1.0% cream	14% to 20% of BSA treated BID with INCB018424 1.5% cream	Total of all reporting groups
Overall Participants	5	5	5	5	5	25
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	37.8 (6.22)	32.4 (7.57)	43.2 (13.94)	46.2 (12.21)	42.8 (18.16)	40.5 (12.36)
Sex/Gender, Customized (Number) [Number]
Male	5 100%	3 60%	4 80%	4 80%	4 80%	20 80%
Female	0 0%	2 40%	1 20%	1 20%	1 20%	5 20%
Race/Ethnicity, Customized (Number) [Number]
American Indian/Alaskan Native White	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian/Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
White or Caucasian	4 80%	5 100%	5 100%	5 100%	3 60%	22 88%
Other	1 20%	0 0%	0 0%	0 0%	2 40%	3 12%
Race/Ethnicity, Customized (Number) [Number]
Hispanic or Latino	1 20%	1 20%	1 20%	0 0%	1 20%	4 16%
Not Hispanic or Latino	4 80%	4 80%	4 80%	5 100%	4 80%	21 84%

Outcome Measures

1. Primary Outcome

Title	Number of Treatment of Emergent Adverse Events
Description	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Time Frame	Approximately 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A	Cohort B	Cohort C	Cohort D	Cohort E
Arm/Group Description	2% to 7% of BSA treated BID with INCB018424 1.5% cream	8% to 13% of BSA treated BID with INCB018424 1.5% cream	14% to 20% of BSA treated QD with INCB018424 1.5% cream	14% to 20% of BSA treated BID with INCB018424 1.0% cream	14% to 20% of BSA treated BID with INCB018424 1.5% cream
Measure Participants	5	5	5	5	5
Count of Participants [Participants]	2 40%	4 80%	2 40%	1 20%	2 40%

2. Primary Outcome

Title	Pharmacokinetics Parameter : Skin Flux of INCB018424
Description	The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.
Time Frame	Days 1, 4, 8, 15, 22, and 28-30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A	Cohort B	Cohort C	Cohort D	Cohort E
Arm/Group Description	2% to 7% of BSA treated BID with INCB018424 1.5% cream	8% to 13% of BSA treated BID with INCB018424 1.5% cream	14% to 20% of BSA treated QD with INCB018424 1.5% cream	14% to 20% of BSA treated BID with INCB018424 1.0% cream	14% to 20% of BSA treated BID with INCB018424 1.5% cream
Measure Participants	5	5	5	5	5
Mean (Standard Deviation) [ng/cm^2/h]	180 (126)	131 (92)	60 (43)	151 (126)	152 (74)

3. Primary Outcome

Title	Pharmacokinetics Parameter: Bioavailability of INCB018424
Description	The INCB018424 bioavailability was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.
Time Frame	Approximately one month: Days 1, 4, 8, 15, 22, and 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A	Cohort B	Cohort C	Cohort D	Cohort E
Arm/Group Description	2% to 7% of BSA treated BID with INCB018424 1.5% cream	8% to 13% of BSA treated BID with INCB018424 1.5% cream	14% to 20% of BSA treated QD with INCB018424 1.5% cream	14% to 20% of BSA treated BID with INCB018424 1.0% cream	14% to 20% of BSA treated BID with INCB018424 1.5% cream
Measure Participants	5	5	5	5	5
Mean (Standard Deviation) [percentage]	3.8 (2.5)	4.1 (3.4)	3.4 (1.9)	3.9 (1.3)	5.2 (1.9)

4. Secondary Outcome

Title	Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
Description	Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12.
Time Frame	Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A: Control Lesion	Cohort A	Cohort B: Control Lesion	Cohort B	Cohort C: Control Lesion	Cohort C	Cohort D: Control Lesion	Cohort D	Cohort E: Control Lesion	Cohort E
Arm/Group Description	Control Lesions were not treated.	2% to 7% of BSA treated BID with INCB018424 1.5% cream	Control Lesions were not treated.	8% to 13% of BSA treated BID with INCB018424 1.5% cream	Control Lesions were not treated.	14% to 20% of BSA treated QD with INCB018424 1.5% cream	Control Lesions were not treated.	14% to 20% of BSA treated BID with INCB018424 1.0% cream	Control Lesions were not treated.	14% to 20% of BSA treated BID with INCB018424 1.5% cream
Measure Participants	5	5	5	5	5	5	5	5	5	5
Day 8	.4	-1.4	-0.8	-4.0	-0.2	-1.2	-0.2	-1.2	0.2	-2.8
Day 15	0.2	-3.2	-2.00	-4.2	-0.6	-2.6	0.8	-0.8	-0.8	-3.6
Day 22	1.0	-2.8	-1.8	-5.0	-2.8	-3.6	1.0	-2.8	-0.4	-3.6
Day 28	0.8	-3.4	-2.0	-5.4	-3.6	-4.4	0.6	-3.6	-1.2	-3.8
Follow-up	1.2	-1.2	1.0	-3.6	-4.2	-3.2	0.6	-1.0	-2.0	-2.8

5. Secondary Outcome

Title	Mean Change in Psoriatic Lesion Area
Description	The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area.
Time Frame	Days 1 and 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A: Control Lesion	Cohort A	Cohort B: Control Lesion	Cohort B	Cohort C: Control Lesion	Cohort C	Cohort D: Control Lesion	Cohort D	Control E: Control Lesion	Cohort E
Arm/Group Description	Control lesions were not treated.	2% to 7% of BSA treated BID with INCB018424 1.5% cream	Control lesions were not treated.	8% to 13% of BSA treated BID with INCB018424 1.5% cream	Control lesions were not treated.	14% to 20% of BSA treated QD with INCB018424 1.5% cream	Control lesions were untreated.	14% to 20% of BSA treated BID with INCB018424 1.0% cream	Control Lesions were untreated.	14% to 20% of BSA treated BID with INCB018424 1.5% cream
Measure Participants	5	5	5	5	5	5	5	5	5	5
Mean (Standard Deviation) [cm^2]	-2.20 (23.993)	-237.76 (240.500)	-15.94 (38.247)	-620.56 (714.829)	0.40 (11.336)	-1267.78 (1009.159)	-9.02 (10.346)	-871.12 (1062.346)	-12.32 (23.283)	-823.78 (313.733)

6. Secondary Outcome

Title	Mean Change in Physicians Global Assessment Score
Description	The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments. Note that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores.
Time Frame	Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A	Cohort B	Cohort C	Cohort D	Cohort E
Arm/Group Description	2% to 7% of BSA treated BID with INCB018424 1.5% cream	8% to 13% of BSA treated BID with INCB018424 1.5% cream	14% to 20% of BSA treated QD with INCB018424 1.5% cream	14% to 20% of BSA treated BID with INCB018424 1.0% cream	14% to 20% of BSA treated BID with INCB018424 1.5% cream
Measure Participants	5	5	5	5	5
Screening	4.4 (0.55)	4.4 (0.89)	4.2 (0.45)	4.4 (0.55)	4.0 (0.00)
Day 1	4.0 (0.00)	4.4 (0.89)	4.2 (0.45)	4.4 (0.55)	4.0 (0.00)
Day 8	3.4 (0.55)	3.6 (0.55)	4.0 (0.71)	4.2 (0.45)	3.0 (0.00)
Day 15	2.6 (0.55)	3.2 (0.84)	3.8 (0.84)	3.8 (0.45)	2.6 (0.55)
Day 22	2.4 (0.55)	3.0 (0.71)	3.6 (0.89)	3.2 (0.45)	2.6 (0.55)
Day 28	2.4 (0.55)	2.6 (0.89)	3.4 (0.55)	3.0 (0.71)	2.4 (0.55)
Follow-up	3.4 (0.89)	3.4 (0.89)	3.2 (1.30)	4.0 (0.71)	3.2 (0.45)

7. Primary Outcome

Title	Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424
Description	All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.
Time Frame	Approximately one month: Days 1, 4, 8, 15, 22, and 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A	Cohort B	Cohort C	Cohort D	Cohort E
Arm/Group Description	2% to 7% of BSA treated BID with INCB018424 1.5% cream	8% to 13% of BSA treated BID with INCB018424 1.5% cream	14% to 20% of BSA treated QD with INCB018424 1.5% cream	14% to 20% of BSA treated BID with INCB018424 1.0% cream	14% to 20% of BSA treated BID with INCB018424 1.5% cream
Measure Participants	5	5	5	5	5
Mean (Standard Deviation) [nM]	7.00 (2.10)	28.38 (13.10)	24.41 (10.07)	34.97 (20.44)	60.98 (73.85)

Adverse Events

Arm/Group Title	Cohort A		Cohort B		Cohort C		Cohort D		Cohort E		Total
Arm/Group Description	2 to 7% of BSA treated BID with INCB018424 1.5% cream		8 to 13% of BSA treated BID with INCB018424 1.5% cream BID		14 to 20% of BSA treated QD with INCB018424 1.5% cream QD		14-20% of BSA with INCB018424 1.0% cream BID		14 to 20% of BSA treated BID with INCB018424 1.5% cream BID		Total
All Cause Mortality
	Cohort A		Cohort B		Cohort C		Cohort D		Cohort E		Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/5 (0%)		0/5 (0%)		0/25 (0%)
Serious Adverse Events
	Cohort A		Cohort B		Cohort C		Cohort D		Cohort E		Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)		1/5 (20%)		0/5 (0%)		0/5 (0%)		1/25 (4%)
Psychiatric disorders
Schizophrenia, paranoid type	0/5 (0%)	0	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	1
Other (Not Including Serious) Adverse Events
	Cohort A		Cohort B		Cohort C		Cohort D		Cohort E		Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/5 (40%)		4/5 (80%)		2/5 (40%)		1/5 (20%)		2/5 (40%)		11/25 (44%)
Blood and lymphatic system disorders
Leukopenia	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	1
Lymphadenopathy	0/5 (0%)	0	1/5 (20%)	2	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	2
Reticulocytosis	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	1
Cardiac disorders
Sinus tachycardia	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	1
Gastrointestinal disorders
Abdominal pain upper	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	1
Diarrhoea	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/5 (20%)	1	1/25 (4%)	1
Toothache	0/5 (0%)	0	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	1
General disorders
Application site irritation	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	1/25 (4%)	1
Immune system disorders
Seasonal allergy	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	1/5 (20%)	1	1/5 (20%)	1	2/25 (8%)	2
Infections and infestations
Bacterial infection	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	1
Gastroenteritis	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	1/25 (4%)	1
Injury, poisoning and procedural complications
Excoriation	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	1/25 (4%)	1
Muscle strain	0/5 (0%)	0	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	1
Scratch	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	1
Musculoskeletal and connective tissue disorders
Flank pain	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/5 (20%)	1	1/5 (20%)	1	1/25 (4%)	1
Nervous system disorders
Headache	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	1/5 (20%)	1	1/5 (20%)	1	3/25 (12%)	3
Hypoaesthesia	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/5 (20%)	1	1/25 (4%)	1
Tension headache	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/5 (20%)	1	1/5 (20%)	1	1/25 (4%)	1
Renal and urinary disorders
Haematuria	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	1
Respiratory, thoracic and mediastinal disorders
Nasal congestion	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	1
Sinus congestion	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	1/25 (4%)	1
Skin and subcutaneous tissue disorders
Psoriasis	0/5 (0%)	0	1/5 (20%)	1	0/5 (0%)	0	0/5 (0%)	0	0/5 (0%)	0	1/25 (4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Clinical Study Agreement