Epidermolysis Bullosa
Conditions
Brief summary
To determine if Serlopitant (when taken by mouth) is safe and works on itch in patients aged 13 and above with EB.
Detailed description
The investigator will determine whether more patients taking serlopitant 5 mg daily as compared to placebo can achieve at least a 3-point reduction in the 24-hour Average Itch Numeric Rating Scale (NRS) following two months of treatment. Secondary objectives include; 1. comparative weekly change in daily worst itch NRS, 2. comparative weekly change in daily average itch NRS, 3. the proportion of patients who achieve at least 30% or 50% reduction in Average Itch NRS at month 2, 4. proportion of patients achieving 2-point and 4-point reductions in Average Itch NRS at month 2, 5. Patient Global Impression of Change (PGIC) at month 2, the change in participant static assessment of itch at month 2, and 6. assessment of the safety of serlopitant in adolescents (≥13 y.o.) and adults with epidermolysis bullosa-related itch.
Interventions
DRUGSerlopitant Tablet
Serlopitant is a small molecule, highly selective NK1-R (neurokinin-1 receptor) antagonist. Two critical mediators of the urge to scratch are Substance P, or SP, and its receptor, NK1-R. SP is a naturally occurring peptide in the tachykinin neuropeptide family. Tachykinins have a broad range of functions in the nervous and immune systems. SP binding of NK1-R has been shown to be a key mediator of sensory nerve signaling, including the itch-scratch reflex and the vomiting reflex.
DRUGPlacebo Oral Tablet
The placebo is a tablet that looks like a drug but has no drug or other active ingredient in it.
Sponsors
Epidermolysis Bullosa Research Partnership
Vyne Therapeutics Inc.
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double-blind study.
Intervention model description
This is an investigator-initiated, single-center, randomized, double-blind, placebo-controlled, parallel-arm trial evaluating the effects of serlopitant at 5 mg by mouth daily on EB-related itch.
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females who are at least 13 years of age. 2. Willing and able to understand and sign informed assent/consent. Adolescents will need a parent or guardian willing and able to give consent. 3. Clinical diagnosis of epidermolysis bullosa (dystrophic, junctional or simplex). 4. History of chronic pruritus of at least 6 weeks in duration 5. On the Screening Visit or Screening phone call, patients must have an NRS pruritus score of at least 5 on average itch score in the past 24 hours 6. Female subjects must be of non-childbearing potential (ie, post-menopausal for at least 1 year, had a hysterectomy, or had a tubal ligation) or, if of childbearing potential, must have a confirmed negative urine pregnancy test prior to study treatment and be willing to use effective contraception for the duration of the trial. Effective contraception is defined as follows: oral/implant/injectable/ transdermal contraceptives, intrauterine device, condom with spermicide, or diaphragm with spermicide. Abstinence or partner's vasectomy is acceptable if the female agrees to use effective contraception if she decides to discontinue abstinence or to have sexual intercourse with a non-vasectomized partner. 7. Judged to be in good health based upon the results of a physical examination, medical history, and safety laboratory tests.
Exclusion criteria
1. Have any medical condition or disability that would interfere with the assessment of safety or efficacy in this trial or would compromise the ability of the subject to travel to Stanford or to undergo study procedures or to give informed consent. 2. Have a history of sensitivity to any components of the study material. 3. Are females of childbearing potential who are unwilling to use adequate contraception or who are breast feeding. 4. Have any chronic or acute medical condition that, in the opinion of the investigator, might interfere with the study results or place the subject at undue risk. 5. Have chronic renal disease, i.e., serum creatinine greater than 2 times the upper limit of normal. 6. Have chronic liver disease. Subjects with hepatitis B and C who have normal liver function may be enrolled. 7. Have a current malignancy (such as Hodgkin's lymphoma, B or T cell lymphoma, or myeloma) or blood cell dyscrasia (e.g., polycythemia or myelofibrosis) that would lead to systemic chronic pruritus. 8. Have a history of thyroid cancer, thyroid nodules, inadequately treated thyroid disease, or abnormal TSH or free T4 at screening. 9. Have a history of abnormalities in adrenal or pituitary function (pituitary adenoma, adrenal insufficiency, or adrenal nodule). 10. Screening cortisol level \< 3 mcg/dL 11. Unevaluated abnormalities in cortisol, ACTH, or prolactin. 12. Have pruritus of psychogenic etiology (delusions of parasitosis, obsessive compulsive disorder and major depression) or neuropathic etiology (due to shingles, spinal cord injury or with neurologic deficit). 13. Have pruritus due to urticaria, drug allergy, or infection (such as pityriasis rosacea or tinea or active human immunodeficiency virus \[HIV\]). Note: Subjects with HIV who have undetectable viral load, and stable retro-viral therapy may enroll. 14. Have taken investigational medications within 30 days prior to Screening. 15. Are unwilling to discontinue specific medications that, in the view of the investigator may have significant interactions with the trial drug, for at least two weeks prior to initiation of study and throughout the study period (this includes miconazole, delavirdine, conivaptan, Clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir). 16. Are unable or unwilling to maintain their current anti-itch and opioid-based pain medications at a stable dosage through the course of the two months of active treatment (including but not limited to opioid pain medications, antihistamines, and gabapentin) 17. Started or changed medications, creams, or emollients including over-the-counter (OTC) preparations or bath oil treatment specifically for relief of pruritus within 30 days prior to Screening. 18. Within in the past 12 months, have expressed suicidal ideation with some intent to act. 19. Have any social or medical condition (e.g. alcoholism, drug dependency, psychotic state) that, in the investigator's opinion, might interfere with the subject's ability to comply with the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Achieve at Least a 3-point Reduction in AI-NRS. | baseline and after two months of treatment | Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Achieve at Least a 4-point Reduction in AI-NRS. | baseline and after two months of treatment | Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. |
| Number of Patients Who Achieve at Least a 30% Reduction in AI-NRS. | baseline and after two months of treatment | Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. |
| Number of Patients Who Achieve at Least a 50% Reduction in AI-NRS. | baseline and after two months of treatment | Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. |
| Number of Patients Who Achieve at Least a 2-point Reduction in AI-NRS. | baseline and after two months of treatment | Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. |
| Weekly AI-NRS | baseline and week 1, 2, 3, 4, 5, 6, 7, and 8 | Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. |
| Patient Global Impression of Change (PGIC) | month 2 | PGIC categorized as Very much better, Moderately better, A little better, No change, A little worse, Moderately worse, and Very much worse. |
| Change in Static Participant Assessment of Itch | month 2 | Severity of itch over past 7 days assessed as Very Severe, Severe, Moderate, Mild, or None. Change is reported as the number of participants with 3-category improvement, 2-category improvement, 1-category improvement, no change, or worse. |
| Weekly Worst Itch NRS | baseline and week 1, 2, 3, 4, 5, 6, 7, and 8 | Participants will be asked to complete a daily itch diary with their worst itch numeric rating scale (WI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching. |
Countries
United States
Participant flow
Pre-assignment details
Four participants were consented but failed initial screening and were not allocated to treatment. Two participants failed initial screening but were re-screened and entered the study. A protocol amendment in May 2020 changed the duration of the follow-up period from 12 months to 3 months.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Oral Tablet Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring. | 12 |
| Serlopitant Tablet Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Blinded Phase (2 Months) | Adverse Event | 0 | 1 | 0 |
| Blinded Phase (2 Months) | Physician Decision | 0 | 1 | 0 |
| Open-label Extension (3 or 12 Months) | Enrolled in other clinical study | 0 | 0 | 1 |
| Open-label Extension (3 or 12 Months) | Lost to Follow-up | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo Oral Tablet | Total | Serlopitant Tablet |
|---|---|---|---|
| Age, Continuous | 40 years | 31 years | 22 years |
| Average Itch Numeric Rating Scale (AI-NRS) | 6 score on a scale | 6 score on a scale | 7 score on a scale |
| Epidermolysis Bullosa (EB) Subtype Dominant dystrophic EB | 1 Participants | 3 Participants | 2 Participants |
| Epidermolysis Bullosa (EB) Subtype EB simplex | 2 Participants | 3 Participants | 1 Participants |
| Epidermolysis Bullosa (EB) Subtype Junctional EB | 1 Participants | 1 Participants | 0 Participants |
| Epidermolysis Bullosa (EB) Subtype Recessive dystrophic EB | 8 Participants | 17 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 7 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 17 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 6 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 14 Participants | 6 Participants |
| Region of Enrollment United States | 12 Participants | 24 Participants | 12 Participants |
| Sex: Female, Male Female | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 9 / 12 | 10 / 12 | 6 / 10 |
| serious Total, serious adverse events | 0 / 12 | 2 / 12 | 0 / 10 |
Outcome results
Primary
Number of Patients Who Achieve at Least a 3-point Reduction in AI-NRS.
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Time frame: baseline and after two months of treatment
Population: Data were analyzed using the last observation carried forward method (LCOF)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Oral Tablet | Number of Patients Who Achieve at Least a 3-point Reduction in AI-NRS. | 1 Participants |
| Serlopitant Tablet | Number of Patients Who Achieve at Least a 3-point Reduction in AI-NRS. | 3 Participants |
p-value: 0.59Fisher Exact
Secondary
Change in Static Participant Assessment of Itch
Severity of itch over past 7 days assessed as Very Severe, Severe, Moderate, Mild, or None. Change is reported as the number of participants with 3-category improvement, 2-category improvement, 1-category improvement, no change, or worse.
Time frame: month 2
Population: Participants who enrolled after protocol amendment adding this outcome measure are included in the analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Oral Tablet | Change in Static Participant Assessment of Itch | 2-category improvement | 0 Participants |
| Placebo Oral Tablet | Change in Static Participant Assessment of Itch | No change | 3 Participants |
| Placebo Oral Tablet | Change in Static Participant Assessment of Itch | 1-category improvement | 2 Participants |
| Placebo Oral Tablet | Change in Static Participant Assessment of Itch | Worse | 0 Participants |
| Placebo Oral Tablet | Change in Static Participant Assessment of Itch | 3-category improvement | 0 Participants |
| Serlopitant Tablet | Change in Static Participant Assessment of Itch | Worse | 0 Participants |
| Serlopitant Tablet | Change in Static Participant Assessment of Itch | 3-category improvement | 1 Participants |
| Serlopitant Tablet | Change in Static Participant Assessment of Itch | 2-category improvement | 1 Participants |
| Serlopitant Tablet | Change in Static Participant Assessment of Itch | 1-category improvement | 0 Participants |
| Serlopitant Tablet | Change in Static Participant Assessment of Itch | No change | 2 Participants |
Secondary
Number of Patients Who Achieve at Least a 2-point Reduction in AI-NRS.
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Time frame: baseline and after two months of treatment
Population: Data were analyzed using the last observation carried forward method (LCOF)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Oral Tablet | Number of Patients Who Achieve at Least a 2-point Reduction in AI-NRS. | 2 Participants |
| Serlopitant Tablet | Number of Patients Who Achieve at Least a 2-point Reduction in AI-NRS. | 3 Participants |
p-value: 1Fisher Exact
Secondary
Number of Patients Who Achieve at Least a 30% Reduction in AI-NRS.
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Time frame: baseline and after two months of treatment
Population: Data were analyzed using the last observation carried forward method (LCOF)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Oral Tablet | Number of Patients Who Achieve at Least a 30% Reduction in AI-NRS. | 4 Participants |
| Serlopitant Tablet | Number of Patients Who Achieve at Least a 30% Reduction in AI-NRS. | 3 Participants |
p-value: 0.67Fisher Exact
Secondary
Number of Patients Who Achieve at Least a 4-point Reduction in AI-NRS.
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Time frame: baseline and after two months of treatment
Population: Data were analyzed using the last observation carried forward method (LCOF)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Oral Tablet | Number of Patients Who Achieve at Least a 4-point Reduction in AI-NRS. | 1 Participants |
| Serlopitant Tablet | Number of Patients Who Achieve at Least a 4-point Reduction in AI-NRS. | 1 Participants |
p-value: 1Fisher Exact
Secondary
Number of Patients Who Achieve at Least a 50% Reduction in AI-NRS.
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Time frame: baseline and after two months of treatment
Population: Data were analyzed using the last observation carried forward method (LCOF)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Oral Tablet | Number of Patients Who Achieve at Least a 50% Reduction in AI-NRS. | 1 Participants |
| Serlopitant Tablet | Number of Patients Who Achieve at Least a 50% Reduction in AI-NRS. | 1 Participants |
p-value: 1Fisher Exact
Secondary
Patient Global Impression of Change (PGIC)
PGIC categorized as Very much better, Moderately better, A little better, No change, A little worse, Moderately worse, and Very much worse.
Time frame: month 2
Population: Participants who completed the month 2 assessment are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Oral Tablet | Patient Global Impression of Change (PGIC) | A little better | 5 Participants |
| Placebo Oral Tablet | Patient Global Impression of Change (PGIC) | A little worse | 0 Participants |
| Placebo Oral Tablet | Patient Global Impression of Change (PGIC) | Moderately better | 1 Participants |
| Placebo Oral Tablet | Patient Global Impression of Change (PGIC) | Moderately worse | 1 Participants |
| Placebo Oral Tablet | Patient Global Impression of Change (PGIC) | No change | 5 Participants |
| Placebo Oral Tablet | Patient Global Impression of Change (PGIC) | Very much worse | 0 Participants |
| Placebo Oral Tablet | Patient Global Impression of Change (PGIC) | Very much better | 0 Participants |
| Serlopitant Tablet | Patient Global Impression of Change (PGIC) | Very much worse | 0 Participants |
| Serlopitant Tablet | Patient Global Impression of Change (PGIC) | Very much better | 2 Participants |
| Serlopitant Tablet | Patient Global Impression of Change (PGIC) | Moderately better | 0 Participants |
| Serlopitant Tablet | Patient Global Impression of Change (PGIC) | A little better | 3 Participants |
| Serlopitant Tablet | Patient Global Impression of Change (PGIC) | No change | 5 Participants |
| Serlopitant Tablet | Patient Global Impression of Change (PGIC) | A little worse | 0 Participants |
| Serlopitant Tablet | Patient Global Impression of Change (PGIC) | Moderately worse | 0 Participants |
Secondary
Weekly AI-NRS
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Time frame: baseline and week 1, 2, 3, 4, 5, 6, 7, and 8
Population: Daily diary data were averaged weekly. The missing weekly data have been imputed by the mean AI-NRS value of each participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Tablet | Weekly AI-NRS | week 1 | 5.1 score on a scale | Standard Deviation 2.2 |
| Placebo Oral Tablet | Weekly AI-NRS | week 5 | 5.2 score on a scale | Standard Deviation 2 |
| Placebo Oral Tablet | Weekly AI-NRS | week 3 | 5.5 score on a scale | Standard Deviation 2 |
| Placebo Oral Tablet | Weekly AI-NRS | week 6 | 5.0 score on a scale | Standard Deviation 2.1 |
| Placebo Oral Tablet | Weekly AI-NRS | week 2 | 5.3 score on a scale | Standard Deviation 1.9 |
| Placebo Oral Tablet | Weekly AI-NRS | week 7 | 4.8 score on a scale | Standard Deviation 1.7 |
| Placebo Oral Tablet | Weekly AI-NRS | week 4 | 5.4 score on a scale | Standard Deviation 1.7 |
| Placebo Oral Tablet | Weekly AI-NRS | week 8 | 4.8 score on a scale | Standard Deviation 2 |
| Placebo Oral Tablet | Weekly AI-NRS | baseline | 5.3 score on a scale | Standard Deviation 2.2 |
| Serlopitant Tablet | Weekly AI-NRS | week 8 | 5.0 score on a scale | Standard Deviation 2.7 |
| Serlopitant Tablet | Weekly AI-NRS | baseline | 6.3 score on a scale | Standard Deviation 2.3 |
| Serlopitant Tablet | Weekly AI-NRS | week 1 | 5.6 score on a scale | Standard Deviation 2.2 |
| Serlopitant Tablet | Weekly AI-NRS | week 2 | 5.6 score on a scale | Standard Deviation 1.9 |
| Serlopitant Tablet | Weekly AI-NRS | week 3 | 5.2 score on a scale | Standard Deviation 2.4 |
| Serlopitant Tablet | Weekly AI-NRS | week 4 | 5.2 score on a scale | Standard Deviation 2.2 |
| Serlopitant Tablet | Weekly AI-NRS | week 5 | 5.1 score on a scale | Standard Deviation 2.4 |
| Serlopitant Tablet | Weekly AI-NRS | week 6 | 5.1 score on a scale | Standard Deviation 2.6 |
| Serlopitant Tablet | Weekly AI-NRS | week 7 | 5.2 score on a scale | Standard Deviation 2.7 |
Comparison: Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.p-value: 0.1695% CI: [-0.19, 0.03]Mixed Models Analysis
Secondary
Weekly Worst Itch NRS
Participants will be asked to complete a daily itch diary with their worst itch numeric rating scale (WI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Time frame: baseline and week 1, 2, 3, 4, 5, 6, 7, and 8
Population: Daily diary data were averaged weekly. The missing weekly data have been imputed by the mean WI-NRS value of each participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Tablet | Weekly Worst Itch NRS | week 1 | 6.0 score on a scale | Standard Deviation 2.3 |
| Placebo Oral Tablet | Weekly Worst Itch NRS | week 5 | 6.4 score on a scale | Standard Deviation 2.2 |
| Placebo Oral Tablet | Weekly Worst Itch NRS | week 3 | 6.5 score on a scale | Standard Deviation 1.9 |
| Placebo Oral Tablet | Weekly Worst Itch NRS | week 6 | 6.0 score on a scale | Standard Deviation 2.3 |
| Placebo Oral Tablet | Weekly Worst Itch NRS | week 2 | 6.1 score on a scale | Standard Deviation 2 |
| Placebo Oral Tablet | Weekly Worst Itch NRS | week 7 | 6.0 score on a scale | Standard Deviation 2.2 |
| Placebo Oral Tablet | Weekly Worst Itch NRS | week 4 | 6.4 score on a scale | Standard Deviation 1.7 |
| Placebo Oral Tablet | Weekly Worst Itch NRS | week 8 | 6.0 score on a scale | Standard Deviation 2.4 |
| Placebo Oral Tablet | Weekly Worst Itch NRS | baseline | 6.1 score on a scale | Standard Deviation 2.3 |
| Serlopitant Tablet | Weekly Worst Itch NRS | week 8 | 5.4 score on a scale | Standard Deviation 2.1 |
| Serlopitant Tablet | Weekly Worst Itch NRS | baseline | 7.3 score on a scale | Standard Deviation 1.6 |
| Serlopitant Tablet | Weekly Worst Itch NRS | week 1 | 6.3 score on a scale | Standard Deviation 1.7 |
| Serlopitant Tablet | Weekly Worst Itch NRS | week 2 | 5.9 score on a scale | Standard Deviation 1.6 |
| Serlopitant Tablet | Weekly Worst Itch NRS | week 3 | 5.7 score on a scale | Standard Deviation 1.8 |
| Serlopitant Tablet | Weekly Worst Itch NRS | week 4 | 5.6 score on a scale | Standard Deviation 2 |
| Serlopitant Tablet | Weekly Worst Itch NRS | week 5 | 5.7 score on a scale | Standard Deviation 2.2 |
| Serlopitant Tablet | Weekly Worst Itch NRS | week 6 | 5.8 score on a scale | Standard Deviation 2.1 |
| Serlopitant Tablet | Weekly Worst Itch NRS | week 7 | 5.6 score on a scale | Standard Deviation 2.2 |
Comparison: Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.p-value: 0.0995% CI: [-0.24, 0.02]Mixed Models Analysis
Post Hoc
Dressing/Bathing NRS
Participants will be asked to complete a daily itch diary with their itch Numeric Rating Scale (NRS) during dressing/bathing. Score range: 0 to 10, higher scores mean more itching.
Time frame: baseline and week 1, 2, 3, 4, 5, 6, 7, and 8
Population: Daily diary data were averaged weekly. The missing weekly data have been imputed by the mean Dressing/Bathing-NRS value of each participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Tablet | Dressing/Bathing NRS | week 8 | 5.3 score on a scale | Standard Deviation 2.7 |
| Placebo Oral Tablet | Dressing/Bathing NRS | baseline | 5.3 score on a scale | Standard Deviation 2.6 |
| Placebo Oral Tablet | Dressing/Bathing NRS | week 1 | 5.1 score on a scale | Standard Deviation 2.3 |
| Placebo Oral Tablet | Dressing/Bathing NRS | week 2 | 5.0 score on a scale | Standard Deviation 2.1 |
| Placebo Oral Tablet | Dressing/Bathing NRS | week 3 | 5.5 score on a scale | Standard Deviation 2.5 |
| Placebo Oral Tablet | Dressing/Bathing NRS | week 4 | 5.4 score on a scale | Standard Deviation 2.7 |
| Placebo Oral Tablet | Dressing/Bathing NRS | week 5 | 5.6 score on a scale | Standard Deviation 2.6 |
| Placebo Oral Tablet | Dressing/Bathing NRS | week 6 | 5.6 score on a scale | Standard Deviation 2.7 |
| Placebo Oral Tablet | Dressing/Bathing NRS | week 7 | 5.6 score on a scale | Standard Deviation 2.8 |
| Serlopitant Tablet | Dressing/Bathing NRS | week 6 | 5.5 score on a scale | Standard Deviation 3.2 |
| Serlopitant Tablet | Dressing/Bathing NRS | week 4 | 5.1 score on a scale | Standard Deviation 3.1 |
| Serlopitant Tablet | Dressing/Bathing NRS | baseline | 6.8 score on a scale | Standard Deviation 3.1 |
| Serlopitant Tablet | Dressing/Bathing NRS | week 8 | 5.4 score on a scale | Standard Deviation 3.2 |
| Serlopitant Tablet | Dressing/Bathing NRS | week 1 | 5.7 score on a scale | Standard Deviation 3 |
| Serlopitant Tablet | Dressing/Bathing NRS | week 5 | 5.5 score on a scale | Standard Deviation 2.9 |
| Serlopitant Tablet | Dressing/Bathing NRS | week 2 | 6.0 score on a scale | Standard Deviation 2.8 |
| Serlopitant Tablet | Dressing/Bathing NRS | week 7 | 5.4 score on a scale | Standard Deviation 3.2 |
| Serlopitant Tablet | Dressing/Bathing NRS | week 3 | 5.4 score on a scale | Standard Deviation 3.1 |
Comparison: Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.p-value: 0.00295% CI: [-0.41, -0.09]Mixed Models Analysis