Trial Outcomes & Findings for Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis (NCT NCT02975206)

Last Updated: 2021-05-20

Results Overview

Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

484 participants

Primary outcome timeframe

Week 6 compared to Baseline

Results posted on

2021-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Serlopitant 5 mg Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Serlopitant 1 mg Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Placebo Oral Tablet Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks
Overall Study STARTED	161	161	162
Overall Study COMPLETED	134	144	145
Overall Study NOT COMPLETED	27	17	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Serlopitant 5 mg Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Serlopitant 1 mg Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Placebo Oral Tablet Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks
Overall Study Withdrawal by Subject	14	11	11
Overall Study Other (e.g., lost to follow up)	13	6	6

Baseline Characteristics

The row populations here represent the Full Analysis Set, not all subjects randomized.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Serlopitant 5 mg n=161 Participants Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Serlopitant 1 mg n=161 Participants Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Placebo Oral Tablet n=162 Participants Subjects received a 3-tablet Placebo oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks	Total n=484 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=161 Participants	15 Participants n=161 Participants	10 Participants n=162 Participants	45 Participants n=484 Participants
Age, Categorical Between 18 and 65 years	131 Participants n=161 Participants	138 Participants n=161 Participants	149 Participants n=162 Participants	418 Participants n=484 Participants
Age, Categorical >=65 years	10 Participants n=161 Participants	8 Participants n=161 Participants	3 Participants n=162 Participants	21 Participants n=484 Participants
Age, Continuous	35.9 years STANDARD_DEVIATION 16.62 • n=161 Participants	38.1 years STANDARD_DEVIATION 15.16 • n=161 Participants	37.5 years STANDARD_DEVIATION 13.04 • n=162 Participants	37.1 years STANDARD_DEVIATION 15.01 • n=484 Participants
Sex: Female, Male Female	108 Participants n=161 Participants	109 Participants n=161 Participants	108 Participants n=162 Participants	325 Participants n=484 Participants
Sex: Female, Male Male	53 Participants n=161 Participants	52 Participants n=161 Participants	54 Participants n=162 Participants	159 Participants n=484 Participants
Race (NIH/OMB) Race · American Indian or Alaska Native	0 Participants n=161 Participants	0 Participants n=161 Participants	0 Participants n=162 Participants	0 Participants n=484 Participants
Race (NIH/OMB) Race · Asian	22 Participants n=161 Participants	18 Participants n=161 Participants	19 Participants n=162 Participants	59 Participants n=484 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	2 Participants n=161 Participants	1 Participants n=161 Participants	1 Participants n=162 Participants	4 Participants n=484 Participants
Race (NIH/OMB) Race · Black or African American	64 Participants n=161 Participants	67 Participants n=161 Participants	69 Participants n=162 Participants	200 Participants n=484 Participants
Race (NIH/OMB) Race · White	69 Participants n=161 Participants	70 Participants n=161 Participants	68 Participants n=162 Participants	207 Participants n=484 Participants
Race (NIH/OMB) Race · More than one race	2 Participants n=161 Participants	3 Participants n=161 Participants	2 Participants n=162 Participants	7 Participants n=484 Participants
Race (NIH/OMB) Race · Unknown or Not Reported	2 Participants n=161 Participants	2 Participants n=161 Participants	3 Participants n=162 Participants	7 Participants n=484 Participants
Region of Enrollment United States	161 participants n=161 Participants	161 participants n=161 Participants	162 participants n=162 Participants	484 participants n=484 Participants
WI-NRS	8.38 units on a scale STANDARD_DEVIATION 0.993 • n=160 Participants • The row populations here represent the Full Analysis Set, not all subjects randomized.	8.23 units on a scale STANDARD_DEVIATION 1.039 • n=161 Participants • The row populations here represent the Full Analysis Set, not all subjects randomized.	8.26 units on a scale STANDARD_DEVIATION 1.057 • n=158 Participants • The row populations here represent the Full Analysis Set, not all subjects randomized.	8.29 units on a scale STANDARD_DEVIATION 1.029 • n=479 Participants • The row populations here represent the Full Analysis Set, not all subjects randomized.

PRIMARY outcome

Timeframe: Week 6 compared to Baseline

Population: These figures represent full analysis set.

Outcome measures

Outcome measures
Measure	Serlopitant 5 mg n=160 Participants Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Serlopitant 1 mg n=161 Participants Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Placebo Oral Tablet n=158 Participants Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo taken once daily by mouth for 6 weeks
Change in WI-NRS From Baseline to Week 6	-2.25 score on a scale Standard Deviation 2.198	-2.32 score on a scale Standard Deviation 2.418	-2.01 score on a scale Standard Deviation 2.212

SECONDARY outcome

Timeframe: Week 6 compared to Baseline

Population: These figures represent full analysis set.

Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.

Outcome measures

Outcome measures
Measure	Serlopitant 5 mg n=160 Participants Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Serlopitant 1 mg n=161 Participants Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Placebo Oral Tablet n=158 Participants Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo taken once daily by mouth for 6 weeks
WI-NRS 4-point Responder Rate at Week 6	33 Participants	36 Participants	26 Participants

SECONDARY outcome

Timeframe: Week 6 compared to Baseline

Population: These figures represent all participants in the full analysis set who completed the ItchyQol assessment at both Baseline and Week 6.

ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.

Outcome measures

Outcome measures
Measure	Serlopitant 5 mg n=130 Participants Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Serlopitant 1 mg n=142 Participants Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Placebo Oral Tablet n=139 Participants Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo taken once daily by mouth for 6 weeks
Change in Quality of Life (ItchyQoL) From Baseline to Week 6	-0.57 score on a scale Standard Deviation 0.749	-0.58 score on a scale Standard Deviation 0.779	-0.53 score on a scale Standard Deviation 0.683

Adverse Events

Serlopitant 5 mg

Serious events: 2 serious events

Other events: 27 other events

Deaths: 1 deaths

Serlopitant 1 mg

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo Oral Tablet

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Serlopitant 5 mg n=161 participants at risk Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Serlopitant 1 mg n=160 participants at risk Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Placebo Oral Tablet n=158 participants at risk Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks
Infections and infestations Abscess jaw	0.62% 1/161 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	0.00% 0/160 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	0.00% 0/158 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
Injury, poisoning and procedural complications Eye injury	0.00% 0/161 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	0.00% 0/160 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	0.63% 1/158 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.62% 1/161 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	0.00% 0/160 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	0.00% 0/158 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/161 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	0.62% 1/160 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	0.00% 0/158 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/161 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	0.00% 0/160 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	0.63% 1/158 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.

Other adverse events

Other adverse events
Measure	Serlopitant 5 mg n=161 participants at risk Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Serlopitant 1 mg n=160 participants at risk Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks	Placebo Oral Tablet n=158 participants at risk Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks
Infections and infestations Urinary tract infection	3.1% 5/161 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	3.1% 5/160 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	2.5% 4/158 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
Skin and subcutaneous tissue disorders Dermatitis atopic	5.6% 9/161 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	1.2% 2/160 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	3.2% 5/158 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
Infections and infestations Nasopharyngitis	3.7% 6/161 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	1.2% 2/160 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	3.2% 5/158 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
Nervous system disorders Headache	1.2% 2/161 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	1.2% 2/160 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	3.2% 5/158 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
Nervous system disorders Somnolence	1.2% 2/161 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	1.2% 2/160 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	3.2% 5/158 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
Skin and subcutaneous tissue disorders Pruritus	1.9% 3/161 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	5.6% 9/160 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.	5.1% 8/158 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time. The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.

Additional Information

Anna Gururajan

Menlo Therapeutics Inc.

Phone: (650) 486-1416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place