Itch
Conditions
Keywords
itch, pruritus, CIP
Brief summary
Chronic Itch is a debilitating condition affecting many people. Currently, there are no FDA-approved treatments. Apremilast is an FDA-approved oral medication used to successfully treat the inflammatory skin disorder psoriasis and the inflammatory disorder psoriatic arthritis. This study examines if apremiliast taken twice daily relieves chronic itch.
Detailed description
There is no FDA-approved medication for chronic idiopathic pruritus (CIP). Apremilast has demonstrated notable activity and is approved for treatment in other pruritic inflammatory skin conditions such as psoriasis. The drug is currently being investigated as therapy for atopic dermatitis. Additionally, the investigators have preliminary data to suggest that apremilast's anti-inflammatory properties may work via neuromodulation targeting neuronal cytokine pathways. The proposed study plans to assess the efficacy of apremilast 30 mg BID in the setting of CIP. Durable response to a medication is typically seen within one to two months of starting an efficacious medication in subjects who respond. Therefore, the investigators have designed this study to end at Week 16 to definitively determine efficacy and conclude the study with confidence with regard to both efficacy and failure.
Interventions
DRUGApremilast
Apremilast 30 mg BID daily
Sponsors
Celgene Corporation
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: A subject who meets all of the following criteria may be included in the study: * Male and non-pregnant, non-lactating female subjects aged 18 years or older * Diagnosed with chronic idiopathic pruritus (CIP) with an NRS Itch Score of ≥ 7 at both Screening and Baseline * Diagnosis of CIP for at least 6 weeks prior to screening * Willingness to avoid pregnancy or fathering of children * Ability and willingness to provide written informed consent * Willing and able to comply with all study requirements and restrictions * Willing to not participate in any other interventional trial for the duration of their participation * Subjects must be in good health as determined by medical history, physical examination, electrocardiogram, clinical laboratory tests and vital signs * Failure of a course 2-week course of treatment with topical triamcinolone 0.1% ointment BID * Histopathological demonstration of skin eosinophils, mast cell activation, lymphocytic infiltration, and/or dermal edema
Exclusion criteria
Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute NRS Itch Score at Week 16 (End of Treatment) | Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute DLQI at Week 16 | Week 16 | 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). |
| NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18 | Screening through Week 18 (follow up visit) | 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. |
| DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18 | Screening through Week 18 (follow up visit) | Participants will complete a 10 question Dermatology Life Quality Index questionnaire at Screening, Baseline, and Weeks 2,4,8,12,16,18. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label All participants will receive apremilast 30 mg PO BID. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Open Label |
|---|---|
| 1 week NRS itch score | 8 units on a scale STANDARD_DEVIATION 0.91 |
| 24 hour numerical rating scale (NRS) itch score | 9.25 units on a scale |
| Age, Continuous | 70.5 years STANDARD_DEVIATION 11.7 |
| Dermatology Life Quality Index | 11.5 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 5 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Absolute NRS Itch Score at Week 16 (End of Treatment)
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.
Time frame: Week 16
Population: All patients met criteria for chronic pruritus of unknown origin.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Open Label | Absolute NRS Itch Score at Week 16 (End of Treatment) | 24 Hour NRS Itch Score | 7 Units on a scale |
| Open Label | Absolute NRS Itch Score at Week 16 (End of Treatment) | 1 Week NRS Itch Score | 7.5 Units on a scale |
Secondary
Absolute DLQI at Week 16
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).
Time frame: Week 16
Population: Patients who met inclusion criteria with a diagnosis of chronic pruritus of unknown origin
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Open Label | Absolute DLQI at Week 16 | 13 Score on a scale |
Secondary
DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18
Participants will complete a 10 question Dermatology Life Quality Index questionnaire at Screening, Baseline, and Weeks 2,4,8,12,16,18.
Time frame: Screening through Week 18 (follow up visit)
Population: Although we started with 10 patients, patients dropped out of the study as it progressed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label | 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 |
| Open Label | 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 |
| Open Label | 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 |
| Open Label | 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 |
| Open Label | 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 |
| Open Label | 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 |
| Open Label | 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 |
| Open Label | 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 |
Secondary
NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18
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.
Time frame: Screening through Week 18 (follow up visit)
Population: Although we started with 10 patients, patients dropped out of the study as it progressed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label | 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 |
| Open Label | 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 |
| Open Label | 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 |
| Open Label | 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 |
| Open Label | 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 |
| Open Label | 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 |
| Open Label | 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 |
| Open Label | 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 |