Atopic Dermatitis, Pruritus
Conditions
Brief summary
Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis
Detailed description
This is a double-blind, randomized, placebo-controlled study. Approximately 450 subjects will be randomized in a 1:1:1 ratio to receive daily oral doses of serlopitant 1 mg, 5 mg, or placebo for 6 weeks. During the screening period, subjects will be provided with an electronic device for recording electronic diary (eDiary) assessments throughout the study. This eDiary will be used to capture efficacy endpoint data and treatment information. At the Baseline visit, eligible subjects will be randomized, and study drug dispensed beginning with a loading dose of 3 tablets to be taken at bedtime that same day. Starting on Study Day 2, subjects will take one tablet per day at bedtime. Treatment will continue for 6 weeks. The primary efficacy endpoint will be assessed during Week 6. After completion of the 6-week treatment period, all subjects will enter a 4-week follow-up period.
Interventions
DRUGSerlopitant High Dose
serlopitant tablets - high dose
DRUGPlacebo Oral Tablet
placebo tablet
DRUGSerlopitant Low Dose
serlopitant tablets - low dose
Sponsors
Vyne Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age 13 years or older * Pruritus prior to and during the initial screening period * Diagnosis of atopic dermatitis * Judged to be in good health in the investigator's opinion
Exclusion criteria
* Prior treatment with study drug or similar drug * Pruritus due to another reason besides atopic dermatitis * Presence of any medical condition or disability that could interfere with study * History of hypersensitivity to serlopitant or any of its components * Currently pregnant or male partner of pregnant female * Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in WI-NRS From Baseline to Week 6 | Week 6 compared to Baseline | Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WI-NRS 4-point Responder Rate at Week 6 | Week 6 compared to Baseline | Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline. |
| Change in Quality of Life (ItchyQoL) From Baseline to Week 6 | Week 6 compared to Baseline | ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Serlopitant 5 mg Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks | 161 |
| Serlopitant 1 mg Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks | 161 |
| Placebo Oral Tablet Subjects received a 3-tablet Placebo oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks | 162 |
| Total | 484 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Other (e.g., lost to follow up) | 13 | 6 | 6 |
| Overall Study | Withdrawal by Subject | 14 | 11 | 11 |
Baseline characteristics
| Characteristic | Serlopitant 5 mg | Serlopitant 1 mg | Placebo Oral Tablet | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 15 Participants | 10 Participants | 45 Participants |
| Age, Categorical >=65 years | 10 Participants | 8 Participants | 3 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 131 Participants | 138 Participants | 149 Participants | 418 Participants |
| Age, Continuous | 35.9 years STANDARD_DEVIATION 16.62 | 38.1 years STANDARD_DEVIATION 15.16 | 37.5 years STANDARD_DEVIATION 13.04 | 37.1 years STANDARD_DEVIATION 15.01 |
| Race (NIH/OMB) Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Asian | 22 Participants | 18 Participants | 19 Participants | 59 Participants |
| Race (NIH/OMB) Race Black or African American | 64 Participants | 67 Participants | 69 Participants | 200 Participants |
| Race (NIH/OMB) Race More than one race | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Race White | 69 Participants | 70 Participants | 68 Participants | 207 Participants |
| Region of Enrollment United States | 161 participants | 161 participants | 162 participants | 484 participants |
| Sex: Female, Male Female | 108 Participants | 109 Participants | 108 Participants | 325 Participants |
| Sex: Female, Male Male | 53 Participants | 52 Participants | 54 Participants | 159 Participants |
| WI-NRS | 8.38 units on a scale STANDARD_DEVIATION 0.993 | 8.23 units on a scale STANDARD_DEVIATION 1.039 | 8.26 units on a scale STANDARD_DEVIATION 1.057 | 8.29 units on a scale STANDARD_DEVIATION 1.029 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 161 | 0 / 160 | 0 / 158 |
| other Total, other adverse events | 27 / 161 | 22 / 160 | 32 / 158 |
| serious Total, serious adverse events | 2 / 161 | 1 / 160 | 2 / 158 |
Outcome results
Primary
Change in WI-NRS From Baseline to Week 6
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.
Time frame: Week 6 compared to Baseline
Population: These figures represent full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serlopitant 5 mg | Change in WI-NRS From Baseline to Week 6 | -2.25 score on a scale | Standard Deviation 2.198 |
| Serlopitant 1 mg | Change in WI-NRS From Baseline to Week 6 | -2.32 score on a scale | Standard Deviation 2.418 |
| Placebo Oral Tablet | Change in WI-NRS From Baseline to Week 6 | -2.01 score on a scale | Standard Deviation 2.212 |
Secondary
Change in Quality of Life (ItchyQoL) From Baseline to Week 6
ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.
Time frame: Week 6 compared to Baseline
Population: These figures represent all participants in the full analysis set who completed the ItchyQol assessment at both Baseline and Week 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serlopitant 5 mg | Change in Quality of Life (ItchyQoL) From Baseline to Week 6 | -0.57 score on a scale | Standard Deviation 0.749 |
| Serlopitant 1 mg | Change in Quality of Life (ItchyQoL) From Baseline to Week 6 | -0.58 score on a scale | Standard Deviation 0.779 |
| Placebo Oral Tablet | Change in Quality of Life (ItchyQoL) From Baseline to Week 6 | -0.53 score on a scale | Standard Deviation 0.683 |
Secondary
WI-NRS 4-point Responder Rate at Week 6
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.
Time frame: Week 6 compared to Baseline
Population: These figures represent full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Serlopitant 5 mg | WI-NRS 4-point Responder Rate at Week 6 | 33 Participants |
| Serlopitant 1 mg | WI-NRS 4-point Responder Rate at Week 6 | 36 Participants |
| Placebo Oral Tablet | WI-NRS 4-point Responder Rate at Week 6 | 26 Participants |