Trial Outcomes & Findings for A Study Examining the Medication Apremilast as Treatment for Chronic Itch (NCT NCT03239106)

Last Updated: 2021-07-13

Results Overview

Participants will complete a Numeric Rating Scale for itch (0 representing "no itching" through 10 representing "worst itch imaginable") will be recalled from prior 24 hours and the prior week. 0 is the best score (minimum) and 10 is the worst score (maximum) in terms of clinical outcome. This is an ordinal scale that runs from 0 to 10.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Week 16

Results posted on

2021-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Open Label All participants will received apremilast 30 mg PO BID.
Overall Study STARTED	10
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Examining the Medication Apremilast as Treatment for Chronic Itch

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label n=10 Participants All participants will receive apremilast 30 mg PO BID.
Age, Continuous	70.5 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 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	1 Participants n=5 Participants
Race (NIH/OMB) White	9 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	10 participants n=5 Participants
24 hour numerical rating scale (NRS) itch score	9.25 units on a scale n=5 Participants
1 week NRS itch score	8 units on a scale STANDARD_DEVIATION 0.91 • n=5 Participants
Dermatology Life Quality Index	11.5 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: All patients met criteria for chronic pruritus of unknown origin.

Outcome measures

Outcome measures
Measure	Open Label n=10 Participants All participants will receive apremilast 30 mg PO BID. The data were analyzed in an intent-to-treat manner with key primary and secondary endpoints measured as an absolute reduction in NRS itch and DLQI scores, respectively at week 16 from baseline. Thirty percent of the patients completed the study, which did not allow for meaningful intent-to-treat statistical analysis. As an alternative approach, we undertook a LOCF analysis by carrying forward to week 16.
Absolute NRS Itch Score at Week 16 (End of Treatment) 24 Hour NRS Itch Score	7 Units on a scale Interval 1.5 to 10.0
Absolute NRS Itch Score at Week 16 (End of Treatment) 1 Week NRS Itch Score	7.5 Units on a scale Interval 2.0 to 9.25

SECONDARY outcome

Timeframe: Week 16

Population: Patients who met inclusion criteria with a diagnosis of chronic pruritus of unknown origin

Participants will complete a 10 question Dermatology Quality of Life survey at baseline through Week 16 The DLQI is a numerical scale that scores multiple parameters of skin symptoms on a scale from 0 to 30. 0-1 = no effect at all on a patient's life (most favorable clinical outcome and minimum score), 1-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20 = very large effect on patient's life, 21-30 = extremely large effect on patient's life (worse clinical outcome and maximum score).

Outcome measures

Outcome measures
Measure	Open Label n=10 Participants All participants will receive apremilast 30 mg PO BID. The data were analyzed in an intent-to-treat manner with key primary and secondary endpoints measured as an absolute reduction in NRS itch and DLQI scores, respectively at week 16 from baseline. Thirty percent of the patients completed the study, which did not allow for meaningful intent-to-treat statistical analysis. As an alternative approach, we undertook a LOCF analysis by carrying forward to week 16.
Absolute DLQI at Week 16	13 Score on a scale Interval 2.5 to 18.75

SECONDARY outcome

Timeframe: Screening through Week 18 (follow up visit)

Population: Although we started with 10 patients, patients dropped out of the study as it progressed.

Participants' itch will be measured utilizing the Numeric Rating Scale for itch (0 representing "no itching" through 10 representing "worst itch imaginable") will be recalled from prior 24 hours and the prior week. 0 is the best score (minimum) and 10 is the worst score (maximum) in terms of clinical outcome. This is an ordinal scale that runs from 0 to 10.

Outcome measures

Outcome measures
Measure	Open Label n=10 Participants All participants will receive apremilast 30 mg PO BID. The data were analyzed in an intent-to-treat manner with key primary and secondary endpoints measured as an absolute reduction in NRS itch and DLQI scores, respectively at week 16 from baseline. Thirty percent of the patients completed the study, which did not allow for meaningful intent-to-treat statistical analysis. As an alternative approach, we undertook a LOCF analysis by carrying forward to week 16.
NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18 Screening	8.9 Numerical Rating Scale Itch Score Standard Deviation 1.1
NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18 Baseline (Week 0)	7.9 Numerical Rating Scale Itch Score Standard Deviation 1.6
NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18 Week 2	5.7 Numerical Rating Scale Itch Score Standard Deviation 3.7
NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18 Week 4	6.5 Numerical Rating Scale Itch Score Standard Deviation 4.1
NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18 Week 8	7.0 Numerical Rating Scale Itch Score Standard Deviation 4.2
NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18 Week 12	5.7 Numerical Rating Scale Itch Score Standard Deviation 5.1
NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18 Week 16	3.0 Numerical Rating Scale Itch Score Standard Deviation 5.2
NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18 Week 18	1.0 Numerical Rating Scale Itch Score Standard Deviation 0.0

SECONDARY outcome

Timeframe: Screening through Week 18 (follow up visit)

Population: Although we started with 10 patients, patients dropped out of the study as it progressed.

Participants will complete a 10 question Dermatology Life Quality Index questionnaire at Screening, Baseline, and Weeks 2,4,8,12,16,18.

Outcome measures

Outcome measures
Measure	Open Label n=10 Participants All participants will receive apremilast 30 mg PO BID. The data were analyzed in an intent-to-treat manner with key primary and secondary endpoints measured as an absolute reduction in NRS itch and DLQI scores, respectively at week 16 from baseline. Thirty percent of the patients completed the study, which did not allow for meaningful intent-to-treat statistical analysis. As an alternative approach, we undertook a LOCF analysis by carrying forward to week 16.
DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18 Week 12	4.7 Dermatology Life Quality Index Score Standard Deviation 6.4
DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18 Screening	15.3 Dermatology Life Quality Index Score Standard Deviation 7.3
DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18 Baseline (Week 0)	13.7 Dermatology Life Quality Index Score Standard Deviation 7.6
DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18 Week 2	13.3 Dermatology Life Quality Index Score Standard Deviation 9.9
DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18 Week 4	10.8 Dermatology Life Quality Index Score Standard Deviation 9.9
DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18 Week 8	7.5 Dermatology Life Quality Index Score Standard Deviation 6.5
DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18 Week 16	2.3 Dermatology Life Quality Index Score Standard Deviation 2.1
DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18 Week 18	5.0 Dermatology Life Quality Index Score Standard Deviation 5.7

Adverse Events

Open Label

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open Label n=10 participants at risk All participants will receive apremilast 30 mg PO BID.
Gastrointestinal disorders Nausea	30.0% 3/10 • Number of events 3 • Adverse event data were collected until the end of the study visit at Week 18 or earlier if the subject dropped out of the study.
Gastrointestinal disorders Diarrhea	30.0% 3/10 • Number of events 3 • Adverse event data were collected until the end of the study visit at Week 18 or earlier if the subject dropped out of the study.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1 • Adverse event data were collected until the end of the study visit at Week 18 or earlier if the subject dropped out of the study.
General disorders Decreased appetite	10.0% 1/10 • Number of events 1 • Adverse event data were collected until the end of the study visit at Week 18 or earlier if the subject dropped out of the study.
Nervous system disorders Fatigue	10.0% 1/10 • Number of events 1 • Adverse event data were collected until the end of the study visit at Week 18 or earlier if the subject dropped out of the study.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • Adverse event data were collected until the end of the study visit at Week 18 or earlier if the subject dropped out of the study.
Nervous system disorders Presyncope	10.0% 1/10 • Number of events 1 • Adverse event data were collected until the end of the study visit at Week 18 or earlier if the subject dropped out of the study.

Additional Information

Brian Kim, Associate Professor of Medicine

Washington University School of Medicine

Phone: 314-273-1376

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60