Trial Outcomes & Findings for A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN) (NCT NCT02196324)
NCT ID: NCT02196324
Last Updated: 2021-05-20
Results Overview
At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average Visual Analog Scale (VAS) (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.
COMPLETED
PHASE2
128 participants
At Baseline
2021-05-20
Participant Flow
The participants were randomized at 15 sites in Germany.
This study consisted of a screening period of up to 4 weeks. All the assessments were done at screening as per the schedule of assessment.
Participant milestones
| Measure |
Placebo
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
65
|
|
Overall Study
COMPLETED
|
48
|
57
|
|
Overall Study
NOT COMPLETED
|
15
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
|
Overall Study
Adverse Event or Serious Adverse Event
|
6
|
3
|
|
Overall Study
Occurrence of an Exclusion Criterion
|
0
|
1
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN)
Baseline characteristics by cohort
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 Years
STANDARD_DEVIATION 11.14 • n=5 Participants
|
57.1 Years
STANDARD_DEVIATION 12.00 • n=7 Participants
|
57.6 Years
STANDARD_DEVIATION 11.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At BaselinePopulation: The Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.
At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average Visual Analog Scale (VAS) (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.
Outcome measures
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Average Visual Analog Scale at Baseline
|
7.92 Units on a scale
Standard Deviation 1.630
|
7.88 Units on a scale
Standard Deviation 1.311
|
PRIMARY outcome
Timeframe: At Week 2Population: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.
Outcome measures
| Measure |
Placebo
n=61 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=63 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Average Visual Analog Scale at Week 2
|
7.01 Units on a scale
Standard Deviation 2.187
|
6.06 Units on a scale
Standard Deviation 2.236
|
PRIMARY outcome
Timeframe: At Week 4Population: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.
Outcome measures
| Measure |
Placebo
n=54 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Average Visual Analog Scale at Week 4
|
6.32 Units on a scale
Standard Deviation 2.403
|
5.41 Units on a scale
Standard Deviation 2.719
|
PRIMARY outcome
Timeframe: At Week 8Population: Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.
Outcome measures
| Measure |
Placebo
n=46 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=57 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Average Visual Analog Scale at Week 8
|
5.56 Units on a scale
Standard Deviation 2.630
|
4.21 Units on a scale
Standard Deviation 2.746
|
SECONDARY outcome
Timeframe: At Baseline and Week 8Population: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome.
Outcome measures
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
Week 8, Mild Present
|
11 Participants
|
27 Participants
|
|
Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
Week 8, Moderately Present
|
18 Participants
|
17 Participants
|
|
Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
Week 8, Severely Present
|
9 Participants
|
7 Participants
|
|
Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
Week 8, Very Severely Present
|
5 Participants
|
2 Participants
|
|
Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
Baseline, Mild Present
|
2 Participants
|
0 Participants
|
|
Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
Baseline, Moderately Present
|
18 Participants
|
17 Participants
|
|
Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
Baseline, Severely Present
|
20 Participants
|
32 Participants
|
|
Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
Baseline, Very Severely Present
|
22 Participants
|
15 Participants
|
|
Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
Week 8, Not Present
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At Baseline and Week 8Population: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome.
Outcome measures
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
Baseline, Not Present
|
14 Participants
|
21 Participants
|
|
Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
Baseline, Mild Present
|
8 Participants
|
5 Participants
|
|
Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
Baseline, Moderately Present
|
13 Participants
|
21 Participants
|
|
Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
Week 8, Mild Present
|
9 Participants
|
10 Participants
|
|
Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
Week 8, Moderately Present
|
15 Participants
|
8 Participants
|
|
Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
Week 8, Severely Present
|
5 Participants
|
6 Participants
|
|
Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
Week 8, Very Severely Present
|
3 Participants
|
1 Participants
|
|
Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
Baseline, Severely Present
|
18 Participants
|
12 Participants
|
|
Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
Baseline, Very Severely Present
|
9 Participants
|
5 Participants
|
|
Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
Week 8, Not Present
|
11 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: At Baseline and Week 8Population: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome.
Outcome measures
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
Baseline, Not Present
|
26 Participants
|
21 Participants
|
|
Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
Baseline, Mild Present
|
8 Participants
|
14 Participants
|
|
Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
Baseline, Moderately Present
|
11 Participants
|
16 Participants
|
|
Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
Baseline, Severely Present
|
9 Participants
|
10 Participants
|
|
Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
Baseline, Very Severely Present
|
8 Participants
|
3 Participants
|
|
Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
Week 8, Not Present
|
18 Participants
|
30 Participants
|
|
Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
Week 8, Mild Present
|
8 Participants
|
12 Participants
|
|
Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
Week 8, Moderately Present
|
10 Participants
|
7 Participants
|
|
Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
Week 8, Severely Present
|
4 Participants
|
4 Participants
|
|
Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
Week 8, Very Severely Present
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Baseline, Weeks 2, 4, and 8Population: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Worst VAS (worst itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.
Outcome measures
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Worst Visual Analog Scale (VAS)
Baseline
|
8.75 Units on a scale
Standard Deviation 1.316
|
8.43 Units on a scale
Standard Deviation 1.190
|
|
Worst Visual Analog Scale (VAS)
Week 2
|
7.92 Units on a scale
Standard Deviation 1.733
|
6.85 Units on a scale
Standard Deviation 2.157
|
|
Worst Visual Analog Scale (VAS)
Week 4
|
7.46 Units on a scale
Standard Deviation 2.285
|
6.19 Units on a scale
Standard Deviation 2.690
|
|
Worst Visual Analog Scale (VAS)
Week 8
|
6.73 Units on a scale
Standard Deviation 2.591
|
4.82 Units on a scale
Standard Deviation 2.729
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, and 8Population: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
The PGA included a question: Did the pruritus improve during the treatment period (yes/no).
Outcome measures
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)
Week 4
|
29 Participants
|
43 Participants
|
|
Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)
Week 8
|
25 Participants
|
47 Participants
|
|
Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)
Week 2
|
23 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: At Baseline, Weeks 2, 4, and 8Population: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.
Numeric Rating Scale: Using the patient diary, participants rated the following using an 11-point NRS (0 = no itching; to 10 = worst itch imaginable): average itching over the past 24 hours (Average NRS). Higher scores indicated worse outcome.
Outcome measures
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Numeric Rating Scale (NRS)
Baseline
|
7.65 Units on a scale
Standard Deviation 1.669
|
7.60 Units on a scale
Standard Deviation 1.455
|
|
Numeric Rating Scale (NRS)
Week 2
|
6.23 Units on a scale
Standard Deviation 2.043
|
5.50 Units on a scale
Standard Deviation 1.944
|
|
Numeric Rating Scale (NRS)
Week 4
|
5.80 Units on a scale
Standard Deviation 2.133
|
4.91 Units on a scale
Standard Deviation 2.158
|
|
Numeric Rating Scale (NRS)
Week 8
|
5.11 Units on a scale
Standard Deviation 2.320
|
4.02 Units on a scale
Standard Deviation 2.190
|
SECONDARY outcome
Timeframe: At Baseline, Weeks 2, 4, and 8Population: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
At each visit, participants completed a DLQI questionnaire. The DLQI is a validated questionnaire consisting of 10 questions relating to the degree to which the participant's skin condition affected his/her daily activities. The DLQI questionnaire is designed for use in adults, i.e. participants over the age of 16. The scoring of each question is as follows: Very much: scored 3, A lot: scored 2, A little: scored 1, Not at all: scored 0, Not relevant: scored 0, Question 7, 'prevented work or studying': scored 3. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. Interpreting the DLQI Scores: 0 - 1: no effect at all on participant's life, 2 - 5: small effect on participant's life, 6 - 10: moderate effect on participant's life, 11 - 20: very large effect on participant's life, 21 - 30: extremely large effect on participant's life.
Outcome measures
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Dermatology Life Quality Index (DLQI)
Baseline
|
14.9 Units on a scale
Standard Deviation 7.03
|
13.7 Units on a scale
Standard Deviation 6.76
|
|
Dermatology Life Quality Index (DLQI)
Week 2
|
12.4 Units on a scale
Standard Deviation 6.94
|
11.6 Units on a scale
Standard Deviation 6.20
|
|
Dermatology Life Quality Index (DLQI)
Week 4
|
11.6 Units on a scale
Standard Deviation 6.56
|
11.4 Units on a scale
Standard Deviation 6.80
|
|
Dermatology Life Quality Index (DLQI)
Week 8
|
11.3 Units on a scale
Standard Deviation 6.83
|
10.6 Units on a scale
Standard Deviation 7.31
|
SECONDARY outcome
Timeframe: At Baseline, Weeks 2, 4, and 8Population: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
At each visit, participants completed an ItchyQoL questionnaire. The ItchyQoL is a validated questionnaire consisting of 22 questions based on the concerns and issues pertinent to participants with pruritus. Items should be scored for the following answers: Never: 1, Rarely: 2, Sometimes: 3, Often: 4, All the time:5. Higher scores indicated worse outcome. Total Score is obtained by calculating the unweighted mean of all ItchyQoL questions.
Outcome measures
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Pruritus-specific Quality of Life (ItchyQoL)
Week 2
|
3.50 Units on a scale
Standard Deviation 0.795
|
3.36 Units on a scale
Standard Deviation 0.670
|
|
Pruritus-specific Quality of Life (ItchyQoL)
Baseline
|
3.68 Units on a scale
Standard Deviation 0.737
|
3.52 Units on a scale
Standard Deviation 0.679
|
|
Pruritus-specific Quality of Life (ItchyQoL)
Week 4
|
3.36 Units on a scale
Standard Deviation 0.863
|
3.26 Units on a scale
Standard Deviation 0.730
|
|
Pruritus-specific Quality of Life (ItchyQoL)
Week 8
|
3.33 Units on a scale
Standard Deviation 0.876
|
3.09 Units on a scale
Standard Deviation 0.904
|
SECONDARY outcome
Timeframe: At Week 8 / End of TreatmentPopulation: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
At Visits 2 and 5 (or Early termination) only, participants completed the standardized and validated PBI-P questionnaire. Prior to treatment, the first page of the questionnaire, the Patient Needs Questionnaire (PNQ), was administered to determine how different benefits of therapy were relevant for the individual participant. After treatment, using the Patient Benefit Questionnaire (PBQ), participants were asked to evaluate the extent to which the benefits they indicated were important to them were, in fact, realized. From all the items taken together, a weighted total benefit value was calculated, which represented the patient relevant therapy benefits. The mean score greater than 1 is considered to represent a clinically relevant improvement. The items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for "does/did not apply to me" = 5; and missing value = -9. Higher scores indicated better outcome.
Outcome measures
| Measure |
Placebo
n=61 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=63 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Patient Benefit Index, Version for Patients With Pruritus (PBI-P)
|
0.81 Units on a scale
Standard Deviation 0.984
|
1.16 Units on a scale
Standard Deviation 1.095
|
SECONDARY outcome
Timeframe: At Week 8Population: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
Using the IGA, physicians rated change in PN lesions (if any) from +5 ("markedly improved") to -5 ("markedly worse"). Higher scores indicated better outcome.
Outcome measures
| Measure |
Placebo
n=47 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=57 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
Baseline
|
14 Participants
|
7 Participants
|
|
Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
Markedly Improved
|
0 Participants
|
4 Participants
|
|
Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
Largely Improved
|
2 Participants
|
3 Participants
|
|
Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
Moderately To Largely Improved
|
4 Participants
|
3 Participants
|
|
Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
Moderately Improved
|
4 Participants
|
11 Participants
|
|
Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
Mildly Improved
|
9 Participants
|
17 Participants
|
|
Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
Mildly Worse
|
8 Participants
|
5 Participants
|
|
Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
Moderately Worse
|
4 Participants
|
4 Participants
|
|
Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
Moderately To Largely Worse
|
1 Participants
|
1 Participants
|
|
Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
Largely Worse
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 1 and Week 8Population: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Here, number analyzed in each row signifies only the participants with available data that were analyzed for each day and week.
Using the PAS, physicians described, localized, counted, and measured PN lesions. One of the 7 items was: Activity Stage (Stage 0-4: 0 = 0%, 1 = 1-25%, 2 = 26-50%, 3 = 51-75%, 4 = \> 75%) a. Prurigo lesions with excoriations/crusts Participants with PAS activity stage (prurigo lesions with excoriations/crusts) is presented in the below table.
Outcome measures
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Number of Participants With Improvement on Prurigo Activity Score (PAS)
Day 1, 1 - 25 %
|
7 Participants
|
5 Participants
|
|
Number of Participants With Improvement on Prurigo Activity Score (PAS)
Day 1, 26 - 50 %
|
18 Participants
|
19 Participants
|
|
Number of Participants With Improvement on Prurigo Activity Score (PAS)
Day 1, 51 - 75 %
|
17 Participants
|
19 Participants
|
|
Number of Participants With Improvement on Prurigo Activity Score (PAS)
Day 1, >75 %
|
21 Participants
|
21 Participants
|
|
Number of Participants With Improvement on Prurigo Activity Score (PAS)
Week 8, 0 %
|
0 Participants
|
4 Participants
|
|
Number of Participants With Improvement on Prurigo Activity Score (PAS)
Week 8, 1 - 25 %
|
11 Participants
|
15 Participants
|
|
Number of Participants With Improvement on Prurigo Activity Score (PAS)
Week 8, 26 - 50 %
|
12 Participants
|
12 Participants
|
|
Number of Participants With Improvement on Prurigo Activity Score (PAS)
Week 8, 51 - 75 %
|
11 Participants
|
11 Participants
|
|
Number of Participants With Improvement on Prurigo Activity Score (PAS)
Week 8, >75 %
|
13 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment, upto 8 WeeksPopulation: The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.
Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine.
Outcome measures
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Participants With Rescue Medication Usage
Pre-treatment Rescue Medication Used
|
15 Participants
|
17 Participants
|
|
Participants With Rescue Medication Usage
Used Rescue Medication
|
12 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10)Population: Safety population - participants who received at least one dose of study drug. This population was analyzed based upon the actual treatment received. Participants with dosing errors were assigned to a treatment group based upon the treatment they received most often.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, without any judgment about causality.
Outcome measures
| Measure |
Placebo
n=63 Participants
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 Participants
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Participants with AEs
|
39 Participants
|
46 Participants
|
|
Number of Participants With Adverse Events (AEs)
Participants with Treatment-emergent adverse events (TEAEs)
|
39 Participants
|
46 Participants
|
|
Number of Participants With Adverse Events (AEs)
Participants with TEAEs leading to discontinuation
|
6 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs)
Participants with TEAEs related to study drug
|
22 Participants
|
31 Participants
|
|
Number of Participants With Adverse Events (AEs)
Participants with TEAEs by maximum severity, Mild
|
14 Participants
|
18 Participants
|
|
Number of Participants With Adverse Events (AEs)
Participants with TEAEs by maximum severity, Moderate
|
22 Participants
|
22 Participants
|
|
Number of Participants With Adverse Events (AEs)
Participants with TEAEs by maximum severity, Severe
|
3 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events (AEs)
Participants with serious TEAEs
|
2 Participants
|
3 Participants
|
Adverse Events
Placebo
Serlopitant
Serious adverse events
| Measure |
Placebo
n=63 participants at risk
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 participants at risk
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
1.6%
1/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
0.00%
0/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
1.6%
1/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
1.6%
1/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
Nervous system disorders
Syncope
|
1.6%
1/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
0.00%
0/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
Psychiatric disorders
Depression
|
0.00%
0/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
1.6%
1/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
0.00%
0/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
Skin and subcutaneous tissue disorders
Actinic elastosis
|
0.00%
0/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
1.6%
1/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
1.6%
1/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
0.00%
0/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
Other adverse events
| Measure |
Placebo
n=63 participants at risk
Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
Serlopitant
n=64 participants at risk
Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
3/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
10.9%
7/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
General disorders
Fatigue
|
6.3%
4/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
9.4%
6/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
General disorders
Oedema peripheral
|
0.00%
0/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
6.2%
4/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
2/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
17.2%
11/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
Infections and infestations
Urinary tract infection
|
6.3%
4/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
0.00%
0/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
Nervous system disorders
Dizziness
|
1.6%
1/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
6.2%
4/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
Nervous system disorders
Headache
|
6.3%
4/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
6.2%
4/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
7/63 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
4.7%
3/64 • From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
|
Additional Information
Iain Stuart, PhD.
Menlo Therapeutics Inc. (formerly Tigercat Pharma, Inc.)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60