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A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02196324
Recruitment Status : Completed
First Posted : July 22, 2014
Results First Posted : February 2, 2021
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
Vyne Therapeutics Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Prurigo Nodularis
Interventions Drug: serlopitant
Drug: Placebo
Enrollment 128
Recruitment Details The participants were randomized at 15 sites in Germany.
Pre-assignment Details 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.
Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 63 65
Completed 48 57
Not Completed 15 8
Reason Not Completed
Withdrawal by Subject             8             4
Adverse Event or Serious Adverse Event             6             3
Occurrence of an Exclusion Criterion             0             1
Other             1             0
Arm/Group Title Placebo Serlopitant Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 63 64 127
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Of the 128 randomized participants, 127 received study drug (63 placebo, 64 serlopitant) and comprised the ITT population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 64 participants 127 participants
58.1  (11.14) 57.1  (12.00) 57.6  (11.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 64 participants 127 participants
Female
36
  57.1%
31
  48.4%
67
  52.8%
Male
27
  42.9%
33
  51.6%
60
  47.2%
1.Primary Outcome
Title Average Visual Analog Scale at Baseline
Hide Description 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.
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 64
Mean (Standard Deviation)
Unit of Measure: Units on a scale
7.92  (1.630) 7.88  (1.311)
2.Primary Outcome
Title Average Visual Analog Scale at Week 2
Hide Description 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.
Time Frame At Week 2
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 61 63
Mean (Standard Deviation)
Unit of Measure: Units on a scale
7.01  (2.187) 6.06  (2.236)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0111
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.5 to -0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.34
Estimation Comments [Not Specified]
3.Primary Outcome
Title Average Visual Analog Scale at Week 4
Hide Description 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.
Time Frame At Week 4
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 54 64
Mean (Standard Deviation)
Unit of Measure: Units on a scale
6.32  (2.403) 5.41  (2.719)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0248
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.8 to -0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.43
Estimation Comments [Not Specified]
4.Primary Outcome
Title Average Visual Analog Scale at Week 8
Hide Description 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.
Time Frame At Week 8
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 46 57
Mean (Standard Deviation)
Unit of Measure: Units on a scale
5.56  (2.630) 4.21  (2.746)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2.6 to -0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.47
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
Hide Description 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.
Time Frame At Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 64
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline, Mild Present Number Analyzed 62 participants 64 participants
2
   3.2%
0
   0.0%
Baseline, Moderately Present Number Analyzed 62 participants 64 participants
18
  29.0%
17
  26.6%
Baseline, Severely Present Number Analyzed 62 participants 64 participants
20
  32.3%
32
  50.0%
Baseline, Very Severely Present Number Analyzed 62 participants 64 participants
22
  35.5%
15
  23.4%
Week 8, Not Present Number Analyzed 45 participants 57 participants
2
   4.4%
4
   7.0%
Week 8, Mild Present Number Analyzed 45 participants 57 participants
11
  24.4%
27
  47.4%
Week 8, Moderately Present Number Analyzed 45 participants 57 participants
18
  40.0%
17
  29.8%
Week 8, Severely Present Number Analyzed 45 participants 57 participants
9
  20.0%
7
  12.3%
Week 8, Very Severely Present Number Analyzed 45 participants 57 participants
5
  11.1%
2
   3.5%
6.Secondary Outcome
Title Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
Hide Description 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.
Time Frame At Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 64
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline, Not Present Number Analyzed 62 participants 64 participants
14
  22.6%
21
  32.8%
Baseline, Mild Present Number Analyzed 62 participants 64 participants
8
  12.9%
5
   7.8%
Baseline, Moderately Present Number Analyzed 62 participants 64 participants
13
  21.0%
21
  32.8%
Baseline, Severely Present Number Analyzed 62 participants 64 participants
18
  29.0%
12
  18.8%
Baseline, Very Severely Present Number Analyzed 62 participants 64 participants
9
  14.5%
5
   7.8%
Week 8, Not Present Number Analyzed 43 participants 56 participants
11
  25.6%
31
  55.4%
Week 8, Mild Present Number Analyzed 43 participants 56 participants
9
  20.9%
10
  17.9%
Week 8, Moderately Present Number Analyzed 43 participants 56 participants
15
  34.9%
8
  14.3%
Week 8, Severely Present Number Analyzed 43 participants 56 participants
5
  11.6%
6
  10.7%
Week 8, Very Severely Present Number Analyzed 43 participants 56 participants
3
   7.0%
1
   1.8%
7.Secondary Outcome
Title Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
Hide Description 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.
Time Frame At Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 64
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline, Not Present Number Analyzed 62 participants 64 participants
26
  41.9%
21
  32.8%
Baseline, Mild Present Number Analyzed 62 participants 64 participants
8
  12.9%
14
  21.9%
Baseline, Moderately Present Number Analyzed 62 participants 64 participants
11
  17.7%
16
  25.0%
Baseline, Severely Present Number Analyzed 62 participants 64 participants
9
  14.5%
10
  15.6%
Baseline, Very Severely Present Number Analyzed 62 participants 64 participants
8
  12.9%
3
   4.7%
Week 8, Not Present Number Analyzed 43 participants 54 participants
18
  41.9%
30
  55.6%
Week 8, Mild Present Number Analyzed 43 participants 54 participants
8
  18.6%
12
  22.2%
Week 8, Moderately Present Number Analyzed 43 participants 54 participants
10
  23.3%
7
  13.0%
Week 8, Severely Present Number Analyzed 43 participants 54 participants
4
   9.3%
4
   7.4%
Week 8, Very Severely Present Number Analyzed 43 participants 54 participants
3
   7.0%
1
   1.9%
8.Secondary Outcome
Title Worst Visual Analog Scale (VAS)
Hide Description 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.
Time Frame At Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 64
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 63 participants 64 participants
8.75  (1.316) 8.43  (1.190)
Week 2 Number Analyzed 61 participants 63 participants
7.92  (1.733) 6.85  (2.157)
Week 4 Number Analyzed 54 participants 64 participants
7.46  (2.285) 6.19  (2.690)
Week 8 Number Analyzed 46 participants 57 participants
6.73  (2.591) 4.82  (2.729)
9.Secondary Outcome
Title Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)
Hide Description The PGA included a question: Did the pruritus improve during the treatment period (yes/no).
Time Frame At Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 64
Measure Type: Count of Participants
Unit of Measure: Participants
Week 2 Number Analyzed 61 participants 63 participants
23
  37.7%
37
  58.7%
Week 4 Number Analyzed 54 participants 64 participants
29
  53.7%
43
  67.2%
Week 8 Number Analyzed 46 participants 57 participants
25
  54.3%
47
  82.5%
10.Secondary Outcome
Title Numeric Rating Scale (NRS)
Hide Description 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.
Time Frame At Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.
Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 64
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 48 participants 48 participants
7.65  (1.669) 7.60  (1.455)
Week 2 Number Analyzed 58 participants 62 participants
6.23  (2.043) 5.50  (1.944)
Week 4 Number Analyzed 52 participants 62 participants
5.80  (2.133) 4.91  (2.158)
Week 8 Number Analyzed 46 participants 54 participants
5.11  (2.320) 4.02  (2.190)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.4 to -0.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.7 to -0.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0175
Comments p-value assume equal variance
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.0 to -0.2
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Dermatology Life Quality Index (DLQI)
Hide Description

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.

Time Frame At Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 64
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 61 participants 61 participants
14.9  (7.03) 13.7  (6.76)
Week 2 Number Analyzed 57 participants 62 participants
12.4  (6.94) 11.6  (6.20)
Week 4 Number Analyzed 51 participants 62 participants
11.6  (6.56) 11.4  (6.80)
Week 8 Number Analyzed 44 participants 55 participants
11.3  (6.83) 10.6  (7.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-3.1 to 1.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-2.7 to 2.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-3.6 to 2.1
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Pruritus-specific Quality of Life (ItchyQoL)
Hide Description

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.

Time Frame At Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 64
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 63 participants 64 participants
3.68  (0.737) 3.52  (0.679)
Week 2 Number Analyzed 61 participants 63 participants
3.50  (0.795) 3.36  (0.670)
Week 4 Number Analyzed 54 participants 64 participants
3.36  (0.863) 3.26  (0.730)
Week 8 Number Analyzed 46 participants 57 participants
3.33  (0.876) 3.09  (0.904)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.6 to 0.1
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Patient Benefit Index, Version for Patients With Pruritus (PBI-P)
Hide Description 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.
Time Frame At Week 8 / End of Treatment
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Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 61 63
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.81  (0.984) 1.16  (1.095)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Serlopitant
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0625
Comments p-value assume equal variance.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
-0.02 to 0.72
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
Hide Description Using the IGA, physicians rated change in PN lesions (if any) from +5 ("markedly improved") to -5 ("markedly worse"). Higher scores indicated better outcome.
Time Frame At Week 8
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Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 47 57
Measure Type: Count of Participants
Unit of Measure: Participants
Markedly Improved
0
   0.0%
4
   7.0%
Largely Improved
2
   4.3%
3
   5.3%
Moderately To Largely Improved
4
   8.5%
3
   5.3%
Moderately Improved
4
   8.5%
11
  19.3%
Mildly Improved
9
  19.1%
17
  29.8%
Baseline
14
  29.8%
7
  12.3%
Mildly Worse
8
  17.0%
5
   8.8%
Moderately Worse
4
   8.5%
4
   7.0%
Moderately To Largely Worse
1
   2.1%
1
   1.8%
Largely Worse
1
   2.1%
2
   3.5%
15.Secondary Outcome
Title Number of Participants With Improvement on Prurigo Activity Score (PAS)
Hide Description

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.

Time Frame At Day 1 and Week 8
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Hide Analysis Population Description

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.

Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 64
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1, 1 - 25 % Number Analyzed 63 participants 64 participants
7
  11.1%
5
   7.8%
Day 1, 26 - 50 % Number Analyzed 63 participants 64 participants
18
  28.6%
19
  29.7%
Day 1, 51 - 75 % Number Analyzed 63 participants 64 participants
17
  27.0%
19
  29.7%
Day 1, >75 % Number Analyzed 63 participants 64 participants
21
  33.3%
21
  32.8%
Week 8, 0 % Number Analyzed 47 participants 57 participants
0
   0.0%
4
   7.0%
Week 8, 1 - 25 % Number Analyzed 47 participants 57 participants
11
  23.4%
15
  26.3%
Week 8, 26 - 50 % Number Analyzed 47 participants 57 participants
12
  25.5%
12
  21.1%
Week 8, 51 - 75 % Number Analyzed 47 participants 57 participants
11
  23.4%
11
  19.3%
Week 8, >75 % Number Analyzed 47 participants 57 participants
13
  27.7%
15
  26.3%
16.Secondary Outcome
Title Participants With Rescue Medication Usage
Hide Description Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine.
Time Frame Pre-treatment, upto 8 Weeks
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Hide Analysis Population Description
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.
Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 64
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-treatment Rescue Medication Used
15
  23.8%
17
  26.6%
Used Rescue Medication
12
  19.0%
8
  12.5%
17.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description 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.
Time Frame From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10)
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Hide Analysis Population Description
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.
Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 64
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with AEs
39
  61.9%
46
  71.9%
Participants with Treatment-emergent adverse events (TEAEs)
39
  61.9%
46
  71.9%
Participants with TEAEs leading to discontinuation
6
   9.5%
3
   4.7%
Participants with TEAEs related to study drug
22
  34.9%
31
  48.4%
Participants with TEAEs by maximum severity, Mild
14
  22.2%
18
  28.1%
Participants with TEAEs by maximum severity, Moderate
22
  34.9%
22
  34.4%
Participants with TEAEs by maximum severity, Severe
3
   4.8%
6
   9.4%
Participants with serious TEAEs
2
   3.2%
3
   4.7%
Time Frame From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Serlopitant
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Placebo Serlopitant
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/64 (0.00%) 
Hide Serious Adverse Events
Placebo Serlopitant
Affected / at Risk (%) Affected / at Risk (%)
Total   2/63 (3.17%)   3/64 (4.69%) 
Cardiac disorders     
Bradycardia * 1  1/63 (1.59%)  0/64 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  0/63 (0.00%)  1/64 (1.56%) 
Nervous system disorders     
Dizziness * 1  0/63 (0.00%)  1/64 (1.56%) 
Syncope * 1  1/63 (1.59%)  0/64 (0.00%) 
Psychiatric disorders     
Depression * 1  0/63 (0.00%)  1/64 (1.56%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure * 1  1/63 (1.59%)  0/64 (0.00%) 
Skin and subcutaneous tissue disorders     
Actinic elastosis * 1  0/63 (0.00%)  1/64 (1.56%) 
Neurodermatitis * 1  1/63 (1.59%)  0/64 (0.00%) 
1
Term from vocabulary, MedDRA version 17
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Serlopitant
Affected / at Risk (%) Affected / at Risk (%)
Total   20/63 (31.75%)   31/64 (48.44%) 
Gastrointestinal disorders     
Diarrhoea * 1  3/63 (4.76%)  7/64 (10.94%) 
General disorders     
Fatigue * 1  4/63 (6.35%)  6/64 (9.38%) 
Oedema peripheral * 1  0/63 (0.00%)  4/64 (6.25%) 
Infections and infestations     
Nasopharyngitis * 1  2/63 (3.17%)  11/64 (17.19%) 
Urinary tract infection * 1  4/63 (6.35%)  0/64 (0.00%) 
Nervous system disorders     
Dizziness * 1  1/63 (1.59%)  4/64 (6.25%) 
Headache * 1  4/63 (6.35%)  4/64 (6.25%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  7/63 (11.11%)  3/64 (4.69%) 
1
Term from vocabulary, MedDRA version 17
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Iain Stuart, PhD.
Organization: Menlo Therapeutics Inc. (formerly Tigercat Pharma, Inc.)
Phone: 1- 800-775-7936
EMail: Iain.Stuart@foamix.com
Layout table for additonal information
Responsible Party: Vyne Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02196324    
Other Study ID Numbers: TCP-102
First Submitted: July 14, 2014
First Posted: July 22, 2014
Results First Submitted: December 10, 2020
Results First Posted: February 2, 2021
Last Update Posted: May 20, 2021