Trial Outcomes & Findings for Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis (NCT NCT01090063)

NCT ID: NCT01090063

Last Updated: 2016-10-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2016-10-28

Participant Flow

Recruitment from Apr 2010 to Sept 2011 in the dermatology clinic of a tertiary care hospital.

Washout of 2 weeks for topicals, 4 weeks for all other biologics and systemics prior to baseline dosage.

Participant milestones

Measure	Main All participants were treated the same
Screen STARTED	28
Screen COMPLETED	24
Screen NOT COMPLETED	4
Treatment STARTED	24
Treatment COMPLETED	20
Treatment NOT COMPLETED	4

Reasons for withdrawal

Measure	Main All participants were treated the same
Screen Screen Failed	4
Treatment Withdrawal by Subject	4

Baseline Characteristics

Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis

Baseline characteristics by cohort

Measure	Main n=24 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Number of participants completing enrollment. Lost values carried forward as last observation carried forward

Outcome measures

Measure	Main n=24 Participants Percentage of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.	Mean Pustule Count at Week 24 Average number of pustules present in all subjects at week 24
Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.	0.375 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: All participants who enrolled. Early terminations were carried as last observation carried forward.

Measurement of subject's palmar and plantar psoriasis severity as measured by the Physician's Global Assessment (PGA) scale, which rates the severity of psoriasis using the measures of erythema, scaling and induration. Scores are from 0 to 4, in 1 unit increments. A score of 4 is very severe, and a score of 0 is clear.

Outcome measures

Measure	Main n=24 Participants Percentage of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.	Mean Pustule Count at Week 24 Average number of pustules present in all subjects at week 24
PGA Score Over Time From Baseline to Week 24	2.5 units on a scale Full Range 1.4 • Interval 0.0 to 4.0	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: All participants who enrolled. Early terminations were carried as last observation carried forward.

Number of pustules present in each subject

Outcome measures

Measure	Main n=24 Participants Percentage of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.	Mean Pustule Count at Week 24 n=24 Participants Average number of pustules present in all subjects at week 24
Pustule Count (if Present at Baseline) From Baseline to Week 24	8.2 pustules Standard Deviation 19.7	13.2 pustules Standard Deviation 28.0

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: All participants who enrolled. Early terminations were carried as last observation carried forward.

Number of discrete fissures on the hands and feet of each subject.

Outcome measures

Measure	Main n=24 Participants Percentage of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.	Mean Pustule Count at Week 24 n=24 Participants Average number of pustules present in all subjects at week 24
Fissure Count (if Present at Baseline) From Baseline to Week 24	3.5 fissures Standard Deviation 5.5	3.7 fissures Standard Deviation 6.8

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: All participants who enrolled. Early terminations were carried as last observation carried forward.

Patient's score on the questionnaire of "how itchy are you", as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).

Outcome measures

Measure	Main n=24 Participants Percentage of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.	Mean Pustule Count at Week 24 n=24 Participants Average number of pustules present in all subjects at week 24
Pruritus Visual Analog Scale From Baseline to Week 24	47.9 units on a scale Standard Deviation 33.4	30 units on a scale Standard Deviation 31.9

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: All participants who enrolled. Early terminations were carried as last observation carried forward.

Patient's score on the questionnaire of "how much pain are you experiencing from your disease of your hands and feet", as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. Visual Analog Scale (VAS). 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).

Outcome measures

Measure	Main n=24 Participants Percentage of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.	Mean Pustule Count at Week 24 n=24 Participants Average number of pustules present in all subjects at week 24
Pain Visual Analog Scale From Baseline to Week 24	50.9 units on a scale Standard Deviation 34.3	30.8 units on a scale Standard Deviation 30.9

SECONDARY outcome

Timeframe: 24 weeks

Population: All participants who enrolled. Participants terminating prior to week 24 had their data carried forward as lost to follow-up.

All adverse events (AE's) will be recorded and monitored. At each of the study visits, patients will be questioned about the occurrence of new AE's since the last visit, or the outcome of any AE's that were reported at previous visits. Upon study completion of the first 10 subjects the principal investigator will review all adverse events to check for trends.

Outcome measures

Measure	Main n=24 Participants Percentage of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.	Mean Pustule Count at Week 24 Average number of pustules present in all subjects at week 24
Safety Outcome Measures	17 participants	—

Adverse Events

Main

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Main n=24 participants at risk
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	16.7% 4/24 • Number of events 4
Skin and subcutaneous tissue disorders Acneiform Eruption	8.3% 2/24 • Number of events 2

Additional Information

Dr. Alice Gottlieb

Tufts Medical Center

Phone: 617-636-7462

Email: Agottlieb@tuftsmedicalcenter.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place