Trial Outcomes & Findings for Effects of Subcutaneous Hyaluronidase Administration on Psoriatic Plaques (NCT NCT01987609)

Results Overview

The Psoriasis Area Severity Index (PASI) of the psoriatic plaques of interest will be measured and compared to baseline values. The PASI is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

4 weeks

Results posted on

2019-01-04

Participant Flow

Unit of analysis: arms

Participant milestones

Participant milestones
Measure	All Study Participants Psoriatic plaques in one arm of each study participant will be injected with Hylenex every week for 4 weeks. Psoriatic plaques on the opposite arm of each study participant will be injected with sterile normal saline every week for 4 weeks.
Overall Study STARTED	7 14
Overall Study Hylenex Injected in Arm	6 6
Overall Study Normal Saline Injected in Arm	6 6
Overall Study COMPLETED	6 12
Overall Study NOT COMPLETED	1 2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Psoriatic plaques in one arm of each study participant will be injected with Hylenex every week for 4 weeks. Psoriatic plaques on the opposite arm of each study participant will be injected with sterile normal saline every week for 4 weeks.
Overall Study Adverse Event	1

Baseline Characteristics

Effects of Subcutaneous Hyaluronidase Administration on Psoriatic Plaques

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=7 Participants Each participant had 1 arm randomized to receive Hylenex, and the other hand randomized to receive Normal Saline.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Age, Continuous	53.8 years STANDARD_DEVIATION 17.4 • n=39 Participants
Sex: Female, Male Female	2 Participants n=39 Participants
Sex: Female, Male Male	5 Participants n=39 Participants
Race/Ethnicity, Customized Caucasian	7 participants n=39 Participants
Region of Enrollment United States	7 participants n=39 Participants

PRIMARY outcome

Timeframe: 4 weeks

The Psoriasis Area Severity Index (PASI) of the psoriatic plaques of interest will be measured and compared to baseline values. The PASI is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).

Outcome measures

Outcome measures
Measure	Hylenex n=7 arms Psoriatic plaques in this arm will be injected with Hylenex every week for 4 weeks. Hylenex	Normal Saline n=7 arms Psoriatic plaques in this arm will be subcutaneously injected with sterile normal saline every week for four weeks Normal Saline
Psoriasis Area Severity Index	5.5 score on a scale Standard Deviation 2.3	5.0 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 4 weeks

A ruler/measuring tape will be used to measure the area of the subject's psoriatic plaques of interest.

Outcome measures

Outcome measures
Measure	Hylenex n=7 arms Psoriatic plaques in this arm will be injected with Hylenex every week for 4 weeks. Hylenex	Normal Saline n=7 arms Psoriatic plaques in this arm will be subcutaneously injected with sterile normal saline every week for four weeks Normal Saline
Plaque Area	12.2 centimeter^2 Standard Deviation 8	9.6 centimeter^2 Standard Deviation 5

SECONDARY outcome

Timeframe: 2 weeks

A ruler/measuring tape will be used to measure the area of the subject's psoriatic plaques of interest.

Outcome measures

Outcome measures
Measure	Hylenex n=6 Arms Psoriatic plaques in this arm will be injected with Hylenex every week for 4 weeks. Hylenex	Normal Saline n=6 Arms Psoriatic plaques in this arm will be subcutaneously injected with sterile normal saline every week for four weeks Normal Saline
Plaque Area	9.3 centimeter^2 Standard Deviation 1.6	6.1 centimeter^2 Standard Deviation 10.8

SECONDARY outcome

Timeframe: 3 weeks

A ruler/measuring tape will be used to measure the area of the subject's psoriatic plaques of interest.

Outcome measures

Outcome measures
Measure	Hylenex n=6 Participants Psoriatic plaques in this arm will be injected with Hylenex every week for 4 weeks. Hylenex	Normal Saline n=6 Participants Psoriatic plaques in this arm will be subcutaneously injected with sterile normal saline every week for four weeks Normal Saline
Plaque Area	13.3 centimeter^2 Standard Deviation 11.02	10.6 centimeter^2 Standard Deviation 11.35

SECONDARY outcome

Timeframe: 1 weeks

A ruler/measuring tape will be used to measure the area of the subject's psoriatic plaques of interest.

Outcome measures

Outcome measures
Measure	Hylenex n=7 Participants Psoriatic plaques in this arm will be injected with Hylenex every week for 4 weeks. Hylenex	Normal Saline n=7 Participants Psoriatic plaques in this arm will be subcutaneously injected with sterile normal saline every week for four weeks Normal Saline
Plaque Area	11.5 centimeter^2 Standard Deviation 12.4	10.4 centimeter^2 Standard Deviation 12.5

SECONDARY outcome

Timeframe: 3 weeks

The Physician Global Assessment (PGA) of the psoriatic plaques of interest will be measured and compared to baseline values on a 0-5 scale where 0 is no evidence of erythema, induration, or scaling, and 5 is severe evidence of these symptoms.

Outcome measures

Outcome measures
Measure	Hylenex n=6 psoriatic plaque Psoriatic plaques in this arm will be injected with Hylenex every week for 4 weeks. Hylenex	Normal Saline n=6 psoriatic plaque Psoriatic plaques in this arm will be subcutaneously injected with sterile normal saline every week for four weeks Normal Saline
Physician Global Assessment (PGA)	2.1 units on a scale Standard Deviation 0.9	2.2 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 2 weeks

The Physician Global Assessment (PGA) of the psoriatic plaques of interest will be measured and compared to baseline values on a 0-5 scale where 0 is no evidence of erythema, induration, or scaling, and 5 is severe evidence of these symptoms.

Outcome measures

Outcome measures
Measure	Hylenex n=6 plaques Psoriatic plaques in this arm will be injected with Hylenex every week for 4 weeks. Hylenex	Normal Saline n=6 plaques Psoriatic plaques in this arm will be subcutaneously injected with sterile normal saline every week for four weeks Normal Saline
Physician Global Assessment (PGA)	2.1 units on a scale Standard Deviation 1.1	2.2 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 1 week

The Physician Global Assessment (PGA) of the psoriatic plaques of interest will be measured and compared to baseline values on a 0-5 scale where 0 is no evidence of erythema, induration, or scaling, and 5 is severe evidence of these symptoms.

Outcome measures

Outcome measures
Measure	Hylenex n=6 psoriatic plaque Psoriatic plaques in this arm will be injected with Hylenex every week for 4 weeks. Hylenex	Normal Saline n=6 psoriatic plaque Psoriatic plaques in this arm will be subcutaneously injected with sterile normal saline every week for four weeks Normal Saline
Physician Global Assessment (PGA)	2.2 units on a scale Standard Deviation 0.9	2.354 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: baseline and 4 weeks

Population: Visual data was collected on CD123 staining of dendritic cells in two subjects. Data on the number of dendritic cells were not collected. Further histology/staining was not done given no significant difference was observed in primary endpoint of clinical improvement at interim analysis.

The histologic appearance of a skin biopsy taken from each of the plaques of interest at the end of the study (4 weeks) will be compared to biopsies taken at baseline. The most important feature to be observed is the number of dendritic cells in the different biopsy specimens.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: Data not collected

RT-PCR techniques will be used to determine expression levels of the inflammatory cytokine TNFα in all skin biopsies. The expression levels of this cytokine in skin biopsies at week 4 will be compared to the expression levels at baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: Data not collected.

RT-PCR techniques will be used to determine expression levels of the inflammatory cytokine IFNα in all skin biopsies. The expression levels of this cytokine in skin biopsies at week 4 will be compared to the expression levels at baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: Data not collected.

RT-PCR techniques will be used to determine expression levels of the TLR-7 in all skin biopsies. The expression levels of this receptor in skin biopsies at week 4 will be compared to the expression levels at baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: Data not collected

RT-PCR techniques will be used to determine expression levels of the TLR-8 in all skin biopsies. The expression levels of this receptor in skin biopsies at week 4 will be compared to the expression levels at baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: Data not collected.

RT-PCR techniques will be used to determine expression levels of the TLR-9 in all skin biopsies. The expression levels of this receptor in skin biopsies at week 4 will be compared to the expression levels at baseline.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week

Any adverse events that subjects have during the course of the study will be recorded at each visit.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Any adverse events that subjects have during the course of the study will be recorded at each visit.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 weeks

Any adverse events that subjects have during the course of the study will be recorded at each visit.

Outcome measures

Outcome data not reported

Adverse Events

Hylenex

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hylenex n=7 participants at risk Psoriatic plaques in this arm will be injected with Hylenex every week for 4 weeks. Hylenex	Normal Saline n=7 participants at risk Psoriatic plaques in this arm will be subcutaneously injected with sterile normal saline every week for four weeks Normal Saline
Skin and subcutaneous tissue disorders Medication Withdrawal Rebound Flare	14.3% 1/7 • Number of events 1 • 3 years	14.3% 1/7 • Number of events 1 • 3 years

Additional Information

Director of Clinical Trials Unit

UCSD Medicine

Phone: 858-657-8322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place