Trial Outcomes & Findings for A Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis (NCT NCT03022617)

Last Updated: 2024-06-06

Results Overview

mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

36 weeks

Results posted on

2024-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Study Group Open-label drug administration group. No comparator. Apremilast
Overall Study STARTED	12
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=12 Participants Open-label drug administration group. No comparator. Apremilast
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 weeks

mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Open-label drug administration group. No comparator. Apremilast
Mean Percent Change of mNAPSI (Modified Nail Area Psoriasis Severity Index) at Week 36 Compared to Baseline for All Nails.	64.1 percentage of reduction in mNAPSI score Interval 46.5 to 81.7

SECONDARY outcome

Timeframe: 12, 24, 36, 48, and 52 weeks

Population: Participants lost to follow-up

The target nail will be defined as the nail that has the highest mNAPSI singe nail score at baseline. This nail will remain the target nail for the remainder of the study. mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)

Outcome measures

Outcome measures
Measure	Study Group n=11 Participants Open-label drug administration group. No comparator. Apremilast
Mean Percent Change in mNAPSI of Target Nail at Weeks 12, 24, 36, 48, and 52 Compared to Baseline. Week 12	53.9 percentage of reduction in mNAPSI score Interval 0.0 to 100.0
Mean Percent Change in mNAPSI of Target Nail at Weeks 12, 24, 36, 48, and 52 Compared to Baseline. Week 24	65.1 percentage of reduction in mNAPSI score Interval 40.0 to 100.0
Mean Percent Change in mNAPSI of Target Nail at Weeks 12, 24, 36, 48, and 52 Compared to Baseline. Week 36	63.8 percentage of reduction in mNAPSI score Interval 20.0 to 100.0
Mean Percent Change in mNAPSI of Target Nail at Weeks 12, 24, 36, 48, and 52 Compared to Baseline. Week 48	57.7 percentage of reduction in mNAPSI score Interval 0.0 to 100.0
Mean Percent Change in mNAPSI of Target Nail at Weeks 12, 24, 36, 48, and 52 Compared to Baseline. Week 52	75.8 percentage of reduction in mNAPSI score Interval 40.0 to 100.0

SECONDARY outcome

Timeframe: 36 and 52 weeks

Population: This was not measured.

mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 52 weeks

Population: Participants were lost to follow-up.

Nail pain VAS is a subjective survey completed by patients. Scores range from 0 to 100 (0=no pain ; 100 = as severe pain as you can imagine). This outcome measure was completed by subtracting the value at Week 52 from the original value at baseline. This was a decrease, which was then divided by the baseline value and multiplied by 100.

Outcome measures

Outcome measures
Measure	Study Group n=4 Participants Open-label drug administration group. No comparator. Apremilast
Percent Change in Patient Reported Nail Pain, as Based on the Nail Pain VAS Score, at Week 52 Compared to Baseline Score.	-50.42 percent change in nail pain score Standard Deviation 2.26

SECONDARY outcome

Timeframe: 52 weeks

Population: Participants lost to follow-up.

Symptoms will be assessed using a visual analogue scale (VAS) for reporting psoriatic arthritis pain, which is a subjective survey that patients will complete on a scale of 0 to 100 (0= no pain ; 100 = as severe pain as you can imagine).This outcome measure was completed by subtracting the value at Week 52 from the original value at baseline. This was a decrease, which was then divided by the baseline value and multiplied by 100.

Outcome measures

Outcome measures
Measure	Study Group n=4 Participants Open-label drug administration group. No comparator. Apremilast
Pain Change in Psoriatic Arthritis (PsA) Symptoms at Week 52 Compared to Baseline, in Patients Who Self-identify as Having Psoriatic Arthritis at Baseline.	-28.97 percentage change in PsA pain symptoms Standard Deviation 3.2

SECONDARY outcome

Timeframe: 52 weeks

Population: All participants were asked about illnesses and other health related events during their time in the study. All were analyzed.

Patients will be asked about illnesses and other health related events while taking part in the study.

Outcome measures

Outcome measures
Measure	Study Group n=12 Participants Open-label drug administration group. No comparator. Apremilast
Safety Adverse Effects Will be Assessed at Each Visit Nausea	5 Participants
Safety Adverse Effects Will be Assessed at Each Visit Abdominal pain	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Acne	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Acute gout	2 Participants
Safety Adverse Effects Will be Assessed at Each Visit Acute eye vision loss	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Bronchitis	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Diarrhea	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Emesis	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Headache	2 Participants
Safety Adverse Effects Will be Assessed at Each Visit Increased bowel movement	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Psoriasis flare	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Wrist skin infection	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Salmonella	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Upper respiratory infections	3 Participants
Safety Adverse Effects Will be Assessed at Each Visit Viral Gastroenteritis	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Worsened Asthma	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Dyspepsia	1 Participants
Safety Adverse Effects Will be Assessed at Each Visit Acute stroke	1 Participants

SECONDARY outcome

Timeframe: 12, 24, 36, 48, and 52 weeks

Population: Data was not collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 and 52 weeks

Population: Participants were lost to follow-up.

mNAPSI is an objective scoring system administered by trained health care providers. Scores range from 0 (no nail disease) to 130 (complete nail involvement in all ten nails.). For week 36 we averaged each participants mNAPSI percent change from baseline to week 36. We did the same thing for week 52

Outcome measures

Outcome measures
Measure	Study Group n=60 Nails Open-label drug administration group. No comparator. Apremilast
Percentage Change From Baseline in mNAPSI. Week 36	17.1 percent change Interval 10.0 to 60.0
Percentage Change From Baseline in mNAPSI. Week 52	30 percent change Interval 10.0 to 62.5

Adverse Events

Study Group

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study Group n=12 participants at risk Open-label drug administration group. No comparator. Apremilast
Nervous system disorders Acute Stroke	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant

Other adverse events

Other adverse events
Measure	Study Group n=12 participants at risk Open-label drug administration group. No comparator. Apremilast
General disorders Nausea	41.7% 5/12 • Number of events 7 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
General disorders Abdominal Pain	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
Skin and subcutaneous tissue disorders acne	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
General disorders acute gout	16.7% 2/12 • Number of events 2 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
Eye disorders Acute Eye Vision Loss	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
Respiratory, thoracic and mediastinal disorders Bronchitis	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
General disorders diarrhea	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
General disorders Emesis	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
General disorders Headache	16.7% 2/12 • Number of events 2 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
General disorders Increased Bowel Movements	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
Skin and subcutaneous tissue disorders Psoriasis Flare	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
Skin and subcutaneous tissue disorders Wrist Skin Infection	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
General disorders Salmonella	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	25.0% 3/12 • Number of events 3 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
General disorders Viral Gastroenteritis	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
Respiratory, thoracic and mediastinal disorders Worsened Asthma	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant
Gastrointestinal disorders Dyspepsia	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the entirety of the study, 52 weeks for each participant

Additional Information

Dr. Boni Elewski

University of Alabama at Birmingham

Phone: 205-502-9960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place