Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN) (NCT NCT05764161)

Last Updated: 2025-12-18

Results Overview

WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in Worst-Itch Numeric Rating Scale (WI-NRS) score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

190 participants

Primary outcome timeframe

Baseline; Week 12

Results posted on

2025-12-18

Participant Flow

Data collected through a cut off date of 30 December 2024 have been included in this summary. Participants were enrolled at 190 sites in Australia, Austria, Bulgaria, Canada, France, Germany, Italy, South Korea, Poland, Spain, Switzerland, and the United States.

Participant milestones

Participant milestones
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
12-week DBVC Period STARTED	94	96
12-week DBVC Period COMPLETED	83	83
12-week DBVC Period NOT COMPLETED	11	13
40-week OLE Period STARTED	83	83
40-week OLE Period COMPLETED	14	11
40-week OLE Period NOT COMPLETED	69	72

Reasons for withdrawal

Reasons for withdrawal
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
12-week DBVC Period Lack of Efficacy	2	1
12-week DBVC Period Lost to Follow-up	0	2
12-week DBVC Period Protocol Violation	2	4
12-week DBVC Period Withdrawal by Subject	7	6
40-week OLE Period Lack of Efficacy	0	1
40-week OLE Period Lost to Follow-up	1	4
40-week OLE Period Withdrawal by Subject	2	7
40-week OLE Period Extended Travel	0	1
40-week OLE Period Ongoing	66	59

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=96 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Total n=190 Participants Total of all reporting groups
Race/Ethnicity, Customized Black or African American	4 Participants n=47 Participants	2 Participants n=41 Participants	6 Participants n=88 Participants
Race/Ethnicity, Customized Asian	8 Participants n=47 Participants	13 Participants n=41 Participants	21 Participants n=88 Participants
Age, Continuous	57.1 years STANDARD_DEVIATION 15.39 • n=47 Participants	56.2 years STANDARD_DEVIATION 14.83 • n=41 Participants	56.6 years STANDARD_DEVIATION 15.08 • n=88 Participants
Sex: Female, Male Female	51 Participants n=47 Participants	55 Participants n=41 Participants	106 Participants n=88 Participants
Sex: Female, Male Male	43 Participants n=47 Participants	41 Participants n=41 Participants	84 Participants n=88 Participants
Race/Ethnicity, Customized White/Caucasian	81 Participants n=47 Participants	75 Participants n=41 Participants	156 Participants n=88 Participants
Race/Ethnicity, Customized Missing	0 Participants n=47 Participants	1 Participants n=41 Participants	1 Participants n=88 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=47 Participants	1 Participants n=41 Participants	1 Participants n=88 Participants
Race/Ethnicity, Customized Hispanic or Latino	9 Participants n=47 Participants	4 Participants n=41 Participants	13 Participants n=88 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	85 Participants n=47 Participants	90 Participants n=41 Participants	175 Participants n=88 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=47 Participants	1 Participants n=41 Participants	1 Participants n=88 Participants

PRIMARY outcome

Timeframe: Baseline; Week 12

Population: Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were defined according to the treatment assignment at the time of randomization regardless of the actual study cream the participant might have applied during their participation in the double-blind, vehicle-controlled period. Participants with a baseline ITCH Score ≥4 were analyzed.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=95 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
WI-NRS4 Response at Week 12	36.2 percentage of participants Interval 26.5 to 46.7	40.0 percentage of participants Interval 30.1 to 50.6

SECONDARY outcome

Timeframe: Baseline; Week 4

Population: ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Participants with missing Week 4 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.

WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=95 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
WI-NRS4 Response at Week 4	19.1 percentage of participants Interval 11.8 to 28.6	30.5 percentage of participants Interval 21.5 to 40.8

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: ITT Population. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.

Overall-Treatment Success was defined as both a WI-NRS4 response and Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS). IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no pruriginous lesions); 1, almost clear (rare palpable pruriginous lesions \[approximately 1-5 lesions\]); 2, mild (few palpable pruriginous lesions \[approximately 6-19 lesions\]); 3, moderate (many palpable pruriginous lesions \[approximately 20-100 lesions\]); 4, severe (abundant palpable pruriginous lesions \[over 100 lesions\]).

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=96 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
Percentage of Participants With Overall-Treatment Success at Week 12	6.4 percentage of participants Interval 2.4 to 13.4	12.5 percentage of participants Interval 6.6 to 20.8

SECONDARY outcome

Timeframe: Baseline; Week 12

IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no lesions); 1, almost clear (rare palpable pruriginous lesions \[approximately 1-5 lesions\]); 2, mild (few palpable pruriginous lesions \[approximately 6-19 lesions\]); 3, moderate (many palpable pruriginous lesions \[approximately 20-100 lesions\]); 4, severe (abundant palpable pruriginous lesions \[over 100 lesions\]).

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=96 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
Percentage of Participants With IGA-CPG-S-TS at Week 12	10.6 percentage of participants Interval 5.2 to 18.7	24.0 percentage of participants Interval 15.8 to 33.7

SECONDARY outcome

Timeframe: Baseline; Day 7

Population: ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=91 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=90 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
WI-NRS4 Response at Day 7	5.5 percentage of participants Interval 1.8 to 12.4	15.6 percentage of participants Interval 8.8 to 24.7

SECONDARY outcome

Timeframe: Baseline; up to Week 52

Population: ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=95 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
WI-NRS4 Response at Each Post-baseline Visit Week 8	31.7 percentage of participants Interval 21.9 to 42.9	45.1 percentage of participants Interval 34.1 to 56.5
WI-NRS4 Response at Each Post-baseline Visit Week 16	69.9 percentage of participants Interval 58.0 to 80.1	58.7 percentage of participants Interval 45.6 to 71.0
WI-NRS4 Response at Each Post-baseline Visit Week 44	66.7 percentage of participants Interval 43.0 to 85.4	75.0 percentage of participants Interval 47.6 to 92.7
WI-NRS4 Response at Each Post-baseline Visit Week 2	4.5 percentage of participants Interval 1.3 to 11.2	15.9 percentage of participants Interval 9.0 to 25.2
WI-NRS4 Response at Each Post-baseline Visit Week 4	21.2 percentage of participants Interval 13.1 to 31.4	32.2 percentage of participants Interval 22.8 to 42.9
WI-NRS4 Response at Each Post-baseline Visit Week 12	43.0 percentage of participants Interval 31.9 to 54.7	47.5 percentage of participants Interval 36.2 to 59.0
WI-NRS4 Response at Each Post-baseline Visit Week 14	54.7 percentage of participants Interval 42.7 to 66.2	49.3 percentage of participants Interval 37.2 to 61.4
WI-NRS4 Response at Each Post-baseline Visit Week 20	72.4 percentage of participants Interval 59.1 to 83.3	61.0 percentage of participants Interval 47.4 to 73.5
WI-NRS4 Response at Each Post-baseline Visit Week 24	74.0 percentage of participants Interval 59.7 to 85.4	67.3 percentage of participants Interval 52.5 to 80.1
WI-NRS4 Response at Each Post-baseline Visit Week 32	83.7 percentage of participants Interval 69.3 to 93.2	68.6 percentage of participants Interval 50.7 to 83.1
WI-NRS4 Response at Each Post-baseline Visit Week 40	72.7 percentage of participants Interval 49.8 to 89.3	68.8 percentage of participants Interval 41.3 to 89.0
WI-NRS4 Response at Each Post-baseline Visit Week 36	79.3 percentage of participants Interval 60.3 to 92.0	76.0 percentage of participants Interval 54.9 to 90.6
WI-NRS4 Response at Each Post-baseline Visit Week 28	83.0 percentage of participants Interval 69.2 to 92.4	71.7 percentage of participants Interval 56.5 to 84.0
WI-NRS4 Response at Each Post-baseline Visit Week 48	66.7 percentage of participants Interval 41.0 to 86.7	85.7 percentage of participants Interval 57.2 to 98.2
WI-NRS4 Response at Each Post-baseline Visit Week 52	70.6 percentage of participants Interval 44.0 to 89.7	84.6 percentage of participants Interval 54.6 to 98.1

SECONDARY outcome

Timeframe: Baseline; up to Week 12

Population: ITT Population. Only participants with available data were analyzed.

The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=96 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 2	-1.14 scores on a scale Standard Error 0.174	-2.01 scores on a scale Standard Error 0.172
DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 4	-1.86 scores on a scale Standard Error 0.216	-2.90 scores on a scale Standard Error 0.212
DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 8	-2.60 scores on a scale Standard Error 0.261	-3.68 scores on a scale Standard Error 0.257
DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 12	-3.06 scores on a scale Standard Error 0.282	-3.94 scores on a scale Standard Error 0.278

SECONDARY outcome

Timeframe: Baseline; up to Week 52

Population: Open-label Extension Population: all participants who applied ruxolitinib 1.5% cream at least once during the OLE Period. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 40	-5.62 scores on a scale Standard Error 2.709	-4.72 scores on a scale Standard Error 2.328
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 44	-5.54 scores on a scale Standard Error 2.603	-5.27 scores on a scale Standard Error 2.449
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 48	-5.39 scores on a scale Standard Error 2.756	-6.02 scores on a scale Standard Error 1.862
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 52	-5.17 scores on a scale Standard Error 2.677	-6.06 scores on a scale Standard Error 2.037
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 14	-4.07 scores on a scale Standard Error 2.434	-4.20 scores on a scale Standard Error 2.440
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 16	-4.82 scores on a scale Standard Error 2.408	-4.40 scores on a scale Standard Error 2.336
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 20	-5.30 scores on a scale Standard Error 2.552	-4.67 scores on a scale Standard Error 2.399
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 24	-5.42 scores on a scale Standard Error 2.357	-5.00 scores on a scale Standard Error 2.393
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 28	-5.83 scores on a scale Standard Error 2.181	-5.17 scores on a scale Standard Error 2.647
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 32	-5.83 scores on a scale Standard Error 2.002	-5.15 scores on a scale Standard Error 2.329
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Change from Baseline at Week 36	-5.73 scores on a scale Standard Error 2.122	-5.56 scores on a scale Standard Error 2.176

SECONDARY outcome

Timeframe: Baseline; up to Week 52

Population: ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Censored participants were included in the analysis.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=95 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
Time to ≥2-point Improvement From Baseline in WI-NRS Score	15.0 days Interval 8.0 to 30.0	5.0 days Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: Baseline; up to Week 52

Population: ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Censored participants were included in the analysis.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=95 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
Time to ≥4-point Improvement From Baseline in WI-NRS Score	63.0 days Interval 35.0 to The upper limit of the confidence interval was not estimable because too few participants had events.	21.0 days Interval 17.0 to 53.0

SECONDARY outcome

Timeframe: Baseline; up to Week 12

Population: ITT Population. Participants with a baseline Skin Pain NRS score ≥2 and available data were analyzed.

Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=91 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 2	22.4 percentage of participants Interval 14.0 to 32.7	40.0 percentage of participants Interval 29.5 to 51.2
DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 4	34.9 percentage of participants Interval 24.8 to 46.2	58.6 percentage of participants Interval 47.6 to 69.1
DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 8	48.1 percentage of participants Interval 36.7 to 59.6	65.8 percentage of participants Interval 54.3 to 76.1
DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 12	60.5 percentage of participants Interval 48.6 to 71.6	73.1 percentage of participants Interval 61.8 to 82.5

SECONDARY outcome

Timeframe: Baseline; up to Week 52

Population: ITT Population. Participants with a baseline Skin Pain NRS score ≥2 and available data were analyzed.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=77 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=74 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 36	84.6 percentage of participants Interval 65.1 to 95.6	95.8 percentage of participants Interval 78.9 to 99.9
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 14	72.2 percentage of participants Interval 60.4 to 82.1	79.7 percentage of participants Interval 68.3 to 88.4
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 16	77.5 percentage of participants Interval 66.0 to 86.5	88.5 percentage of participants Interval 77.8 to 95.3
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 40	78.9 percentage of participants Interval 54.4 to 93.9	86.7 percentage of participants Interval 59.5 to 98.3
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 44	83.3 percentage of participants Interval 58.6 to 96.4	93.3 percentage of participants Interval 68.1 to 99.8
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 48	80.0 percentage of participants Interval 51.9 to 95.7	100.0 percentage of participants Interval 75.3 to 100.0
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 52	78.6 percentage of participants Interval 49.2 to 95.3	100.0 percentage of participants Interval 75.3 to 100.0
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 20	85.5 percentage of participants Interval 73.3 to 93.5	84.2 percentage of participants Interval 72.1 to 92.5
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 24	85.1 percentage of participants Interval 71.7 to 93.8	89.4 percentage of participants Interval 76.9 to 96.5
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 28	90.9 percentage of participants Interval 78.3 to 97.5	84.1 percentage of participants Interval 69.9 to 93.4
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Week 32	87.5 percentage of participants Interval 73.2 to 95.8	90.9 percentage of participants Interval 75.7 to 98.1

SECONDARY outcome

Timeframe: Baseline; up to Week 12

Population: ITT Population. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=96 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 2	-1.06 scores on a scale Standard Error 0.177	-1.86 scores on a scale Standard Error 0.176
DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 4	-1.80 scores on a scale Standard Error 0.229	-2.68 scores on a scale Standard Error 0.225
DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 8	-2.39 scores on a scale Standard Error 0.262	-3.26 scores on a scale Standard Error 0.260
DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 12	-2.97 scores on a scale Standard Error 0.286	-3.57 scores on a scale Standard Error 0.284

SECONDARY outcome

Timeframe: Baseline; up to Week 52

Population: Open-label Extension Population. Only participants with available data were analyzed.

OLE Period: Change from baseline in Skin Pain NRS score at each post-baseline visit

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 52	-3.85 scores on a scale Standard Deviation 3.168	-5.46 scores on a scale Standard Deviation 2.074
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 44	-4.53 scores on a scale Standard Deviation 3.229	-4.46 scores on a scale Standard Deviation 2.497
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 48	-4.09 scores on a scale Standard Deviation 3.420	-5.17 scores on a scale Standard Deviation 2.175
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 36	-5.03 scores on a scale Standard Deviation 2.869	-5.18 scores on a scale Standard Deviation 2.369
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 40	-4.55 scores on a scale Standard Deviation 3.365	-4.24 scores on a scale Standard Deviation 2.341
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 14	-3.81 scores on a scale Standard Deviation 2.599	-3.93 scores on a scale Standard Deviation 2.436
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 16	-4.57 scores on a scale Standard Deviation 2.690	-4.17 scores on a scale Standard Deviation 2.340
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 20	-4.95 scores on a scale Standard Deviation 2.864	-4.38 scores on a scale Standard Deviation 2.449
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 24	-5.16 scores on a scale Standard Deviation 2.818	-4.58 scores on a scale Standard Deviation 2.582
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 28	-5.46 scores on a scale Standard Deviation 2.754	-4.63 scores on a scale Standard Deviation 2.630
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit Week 32	-5.40 scores on a scale Standard Deviation 2.641	-4.80 scores on a scale Standard Deviation 2.409

SECONDARY outcome

Timeframe: Baseline; up to Week 52

Population: ITT Population. Only participants with available data were analyzed.

IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no lesions); 1, almost clear (rare palpable pruriginous lesions \[approximately 1-5 lesions\]); 2, mild (few palpable pruriginous lesions \[approximately 6-19 lesions\]); 3, moderate (many palpable pruriginous lesions \[approximately 20-100 lesions\]); 4, severe (abundant palpable pruriginous lesions \[over 100 lesions\]). Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=96 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 12	12.0 percentage of participants Interval 5.9 to 21.0	27.7 percentage of participants Interval 18.4 to 38.6
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 16	28.4 percentage of participants Interval 18.5 to 40.1	29.7 percentage of participants Interval 18.9 to 42.4
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 20	29.5 percentage of participants Interval 18.5 to 42.6	27.1 percentage of participants Interval 16.4 to 40.3
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 24	30.8 percentage of participants Interval 18.7 to 45.1	32.1 percentage of participants Interval 19.9 to 46.3
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 28	39.6 percentage of participants Interval 25.8 to 54.7	42.6 percentage of participants Interval 28.3 to 57.8
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 32	34.9 percentage of participants Interval 21.0 to 50.9	43.6 percentage of participants Interval 27.8 to 60.4
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 36	38.7 percentage of participants Interval 21.8 to 57.8	46.4 percentage of participants Interval 27.5 to 66.1
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 40	43.5 percentage of participants Interval 23.2 to 65.5	47.1 percentage of participants Interval 23.0 to 72.2
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 44	47.6 percentage of participants Interval 25.7 to 70.2	47.1 percentage of participants Interval 23.0 to 72.2
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 52	47.1 percentage of participants Interval 23.0 to 72.2	61.5 percentage of participants Interval 31.6 to 86.1
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 4	5.6 percentage of participants Interval 1.8 to 12.6	11.8 percentage of participants Interval 6.1 to 20.2
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 8	10.5 percentage of participants Interval 4.9 to 18.9	23.0 percentage of participants Interval 14.6 to 33.2
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 14	23.7 percentage of participants Interval 14.7 to 34.8	31.5 percentage of participants Interval 21.1 to 43.4
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 48	44.4 percentage of participants Interval 21.5 to 69.2	46.7 percentage of participants Interval 21.3 to 73.4
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit Week 2	4.5 percentage of participants Interval 1.2 to 11.1	3.3 percentage of participants Interval 0.7 to 9.2

SECONDARY outcome

Timeframe: Baseline; up to Week 52

Population: ITT Population. Only participants with available data were analyzed.

The Investigator Global Assessment for Activity of Chronic Prurigo (IGA-CPG-A) is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no pruriginous lesions have excoriations or crusts); 1, almost clear (very small proportion of pruriginous lesions have excoriations or crusts \[up to approximately 10% of all pruriginous lesions\]); 2, mild (minority of pruriginous lesions have excoriations or crusts \[approximately 11%-25% of all pruriginous lesions\]); 3, moderate (many pruriginous lesions have excoriations or crusts \[approximately 26%-75% of all pruriginous lesions\]); 4, severe (majority of pruriginous lesions have excoriations or crusts \[approximately 76%-100% of all pruriginous lesions\]).

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=96 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 2	4.5 percentage of participants Interval 1.2 to 11.1	9.8 percentage of participants Interval 4.6 to 17.8
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 4	9.0 percentage of participants Interval 4.0 to 16.9	16.1 percentage of participants Interval 9.3 to 25.2
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 8	17.4 percentage of participants Interval 10.1 to 27.1	26.4 percentage of participants Interval 17.6 to 37.0
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 12	16.9 percentage of participants Interval 9.5 to 26.7	32.5 percentage of participants Interval 22.6 to 43.7
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 14	31.6 percentage of participants Interval 21.4 to 43.3	41.1 percentage of participants Interval 29.7 to 53.2
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 16	43.2 percentage of participants Interval 31.8 to 55.3	45.3 percentage of participants Interval 32.8 to 58.3
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 20	52.5 percentage of participants Interval 39.3 to 65.4	49.2 percentage of participants Interval 35.9 to 62.5
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 24	53.8 percentage of participants Interval 39.5 to 67.8	54.7 percentage of participants Interval 40.4 to 68.4
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 28	58.3 percentage of participants Interval 43.2 to 72.4	63.8 percentage of participants Interval 48.5 to 77.3
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 32	53.5 percentage of participants Interval 37.7 to 68.8	64.1 percentage of participants Interval 47.2 to 78.8
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 36	61.3 percentage of participants Interval 42.2 to 78.2	67.9 percentage of participants Interval 47.6 to 84.1
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 40	47.8 percentage of participants Interval 26.8 to 69.4	47.1 percentage of participants Interval 23.0 to 72.2
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 44	47.6 percentage of participants Interval 25.7 to 70.2	47.1 percentage of participants Interval 23.0 to 72.2
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 48	44.4 percentage of participants Interval 21.5 to 69.2	40.0 percentage of participants Interval 16.3 to 67.7
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit Week 52	52.9 percentage of participants Interval 27.8 to 77.0	53.8 percentage of participants Interval 25.1 to 80.8

SECONDARY outcome

Timeframe: Baseline; up to Week 12

Population: ITT Population. Only participants with available data were analyzed.

The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=96 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit Week 2	9.0 percentage of participants Interval 4.0 to 16.9	12.0 percentage of participants Interval 6.1 to 20.4
DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit Week 4	16.9 percentage of participants Interval 9.8 to 26.3	21.5 percentage of participants Interval 13.7 to 31.2
DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit Week 8	20.9 percentage of participants Interval 12.9 to 31.0	39.1 percentage of participants Interval 28.8 to 50.1
DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit Week 12	31.3 percentage of participants Interval 21.6 to 42.4	42.2 percentage of participants Interval 31.4 to 53.5

SECONDARY outcome

Timeframe: Baseline; up to Week 52

Population: Open-label Extension Population. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit Week 14	36.8 percentage of participants Interval 26.1 to 48.7	47.9 percentage of participants Interval 36.1 to 60.0
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit Week 16	41.9 percentage of participants Interval 30.5 to 53.9	48.4 percentage of participants Interval 35.8 to 61.3
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit Week 20	44.3 percentage of participants Interval 31.5 to 57.6	52.5 percentage of participants Interval 39.1 to 65.7
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit Week 24	40.4 percentage of participants Interval 27.0 to 54.9	56.6 percentage of participants Interval 42.3 to 70.2
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit Week 28	50.0 percentage of participants Interval 35.2 to 64.8	55.3 percentage of participants Interval 40.1 to 69.8
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit Week 32	46.5 percentage of participants Interval 31.2 to 62.3	51.3 percentage of participants Interval 34.8 to 67.6
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit Week 36	48.4 percentage of participants Interval 30.2 to 66.9	53.6 percentage of participants Interval 33.9 to 72.5
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit Week 40	69.6 percentage of participants Interval 47.1 to 86.8	64.7 percentage of participants Interval 38.3 to 85.8
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit Week 44	52.4 percentage of participants Interval 29.8 to 74.3	64.7 percentage of participants Interval 38.3 to 85.8
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit Week 48	50.0 percentage of participants Interval 26.0 to 74.0	60.0 percentage of participants Interval 32.3 to 83.7
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit Week 52	52.9 percentage of participants Interval 27.8 to 77.0	61.5 percentage of participants Interval 31.6 to 86.1

SECONDARY outcome

Timeframe: Baseline; up to Week 12

Population: ITT Population. Only participants with available data were analyzed.

The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was 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 the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=96 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit Change from Baseline at Week 2	-3.81 scores on a scale Standard Error 0.528	-5.14 scores on a scale Standard Error 0.524
DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit Change from Baseline at Week 4	-4.75 scores on a scale Standard Error 0.573	-5.93 scores on a scale Standard Error 0.570
DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit Change from Baseline at Week 8	-5.43 scores on a scale Standard Error 0.638	-6.29 scores on a scale Standard Error 0.634
DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit Change from Baseline at Week 12	-5.72 scores on a scale Standard Error 0.668	-6.38 scores on a scale Standard Error 0.665

SECONDARY outcome

Timeframe: Baseline; up to Week 52

Population: Open-label Extension Population. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit Change from Baseline at Week 14	-6.88 scores on a scale Standard Deviation 5.733	-7.14 scores on a scale Standard Deviation 5.834
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit Change from Baseline at Week 16	-7.07 scores on a scale Standard Deviation 6.327	-7.22 scores on a scale Standard Deviation 5.774
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit Change from Baseline at Week 20	-7.63 scores on a scale Standard Deviation 6.365	-7.09 scores on a scale Standard Deviation 6.062
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit Change from Baseline at Week 24	-7.54 scores on a scale Standard Deviation 5.952	-7.70 scores on a scale Standard Deviation 5.944
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit Change from Baseline at Week 28	-8.23 scores on a scale Standard Deviation 6.502	-7.72 scores on a scale Standard Deviation 6.678
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit Change from Baseline at Week 32	-8.33 scores on a scale Standard Deviation 6.888	-8.15 scores on a scale Standard Deviation 5.475
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit Change from Baseline at Week 36	-8.10 scores on a scale Standard Deviation 8.332	-8.93 scores on a scale Standard Deviation 5.875
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit Change from Baseline at Week 40	-7.17 scores on a scale Standard Deviation 7.315	-7.76 scores on a scale Standard Deviation 4.161
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit Change from Baseline at Week 44	-7.29 scores on a scale Standard Deviation 7.491	-8.47 scores on a scale Standard Deviation 4.346
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit Change from Baseline at Week 48	-7.83 scores on a scale Standard Deviation 8.319	-8.60 scores on a scale Standard Deviation 4.239
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit Change from Baseline at Week 52	-7.47 scores on a scale Standard Deviation 8.776	-9.23 scores on a scale Standard Deviation 4.764

SECONDARY outcome

Timeframe: Baseline; up to Week 12

Population: ITT Population. Only participants with available data were analyzed.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=96 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
DBVC Period: Change From Baseline in European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analog Scale (VAS) Score at Each Postbaseline Visit Change from Baseline at Week 2	4.43 scores on a scale Standard Error 1.791	7.02 scores on a scale Standard Error 1.776
DBVC Period: Change From Baseline in European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analog Scale (VAS) Score at Each Postbaseline Visit Change from Baseline at Week 4	6.52 scores on a scale Standard Error 1.738	8.64 scores on a scale Standard Error 1.727
DBVC Period: Change From Baseline in European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analog Scale (VAS) Score at Each Postbaseline Visit hange from Baseline at Week 8	6.02 scores on a scale Standard Error 1.681	8.84 scores on a scale Standard Error 1.672
DBVC Period: Change From Baseline in European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analog Scale (VAS) Score at Each Postbaseline Visit Change from Baseline at Week 12	7.07 scores on a scale Standard Error 1.816	8.48 scores on a scale Standard Error 1.814

SECONDARY outcome

Timeframe: Baseline; up to Week 52

Population: Open-label Extension Population. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit Change from Baseline at Week 14	10.51 scores on a scale Standard Deviation 17.081	10.15 scores on a scale Standard Deviation 15.211
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit Change from Baseline at Week 16	10.11 scores on a scale Standard Deviation 18.437	11.25 scores on a scale Standard Deviation 14.900
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit Change from Baseline at Week 20	12.33 scores on a scale Standard Deviation 18.678	6.60 scores on a scale Standard Deviation 17.273
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit Change from Baseline at Week 24	10.87 scores on a scale Standard Deviation 20.519	8.42 scores on a scale Standard Deviation 18.392
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit Change from Baseline at Week 28	10.66 scores on a scale Standard Deviation 20.595	8.77 scores on a scale Standard Deviation 19.863
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit Change from Baseline at Week 32	10.21 scores on a scale Standard Deviation 21.577	9.44 scores on a scale Standard Deviation 20.883
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit Change from Baseline at Week 36	12.00 scores on a scale Standard Deviation 24.181	11.86 scores on a scale Standard Deviation 19.669
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit Change from Baseline at Week 40	7.61 scores on a scale Standard Deviation 25.748	9.82 scores on a scale Standard Deviation 18.112
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit Change from Baseline at Week 44	8.48 scores on a scale Standard Deviation 26.776	8.76 scores on a scale Standard Deviation 18.219
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit Change from Baseline at Week 48	10.00 scores on a scale Standard Deviation 29.412	11.47 scores on a scale Standard Deviation 16.604
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit Change from Baseline at Week 52	11.76 scores on a scale Standard Deviation 29.098	12.00 scores on a scale Standard Deviation 12.916

SECONDARY outcome

Timeframe: Baseline; up to Week 12

Population: ITT Population. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=96 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 12, Self-care	-0.17 scores on a scale Standard Deviation 0.601	0.01 scores on a scale Standard Deviation 0.536
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 2, Mobility	-0.15 scores on a scale Standard Deviation 0.736	-0.02 scores on a scale Standard Deviation 0.621
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 4, Mobility	-0.24 scores on a scale Standard Deviation 0.547	-0.02 scores on a scale Standard Deviation 0.431
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 8, Mobility	-0.16 scores on a scale Standard Deviation 0.648	-0.07 scores on a scale Standard Deviation 0.431
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 12, Mobility	-0.16 scores on a scale Standard Deviation 0.689	0.04 scores on a scale Standard Deviation 0.697
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 2, Self-care	-0.06 scores on a scale Standard Deviation 0.793	-0.02 scores on a scale Standard Deviation 0.426
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 4, Self-care	-0.20 scores on a scale Standard Deviation 0.628	-0.07 scores on a scale Standard Deviation 0.334
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 8, Self-care	-0.17 scores on a scale Standard Deviation 0.739	0.01 scores on a scale Standard Deviation 0.500
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 2, Usual activities	-0.25 scores on a scale Standard Deviation 0.962	-0.10 scores on a scale Standard Deviation 0.784
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 4, Usual activities	-0.30 scores on a scale Standard Deviation 0.833	-0.23 scores on a scale Standard Deviation 0.773
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 8, Usual activities	-0.19 scores on a scale Standard Deviation 0.819	-0.12 scores on a scale Standard Deviation 0.697
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 12, Usual activities	-0.24 scores on a scale Standard Deviation 0.759	-0.19 scores on a scale Standard Deviation 0.792
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 2, Pain/discomfort	-0.50 scores on a scale Standard Deviation 0.871	-0.72 scores on a scale Standard Deviation 0.988
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 4, Pain/discomfort	-0.66 scores on a scale Standard Deviation 0.815	-0.89 scores on a scale Standard Deviation 0.982
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 8, Pain/discomfort	-0.80 scores on a scale Standard Deviation 1.125	-0.94 scores on a scale Standard Deviation 1.039
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 12, Pain/discomfort	-0.77 scores on a scale Standard Deviation 1.108	-1.04 scores on a scale Standard Deviation 1.101
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 2, Anxiety/depression	-0.35 scores on a scale Standard Deviation 0.872	-0.43 scores on a scale Standard Deviation 0.796
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 4, Anxiety/depression	-0.44 scores on a scale Standard Deviation 0.895	-0.44 scores on a scale Standard Deviation 0.742
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 8, Anxiety/depression	-0.45 scores on a scale Standard Deviation 0.863	-0.41 scores on a scale Standard Deviation 0.849
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 12, Anxiety/depression	-0.45 scores on a scale Standard Deviation 0.859	-0.46 scores on a scale Standard Deviation 0.791

SECONDARY outcome

Timeframe: Baseline; up to Week 52

Population: Open-label Extension Population. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 14, Mobility	-0.17 scores on a scale Standard Deviation 0.578	-0.01 scores on a scale Standard Deviation 0.686
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 16, Mobility	-0.12 scores on a scale Standard Deviation 0.682	-0.03 scores on a scale Standard Deviation 0.718
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 20, Mobility	-0.17 scores on a scale Standard Deviation 0.557	-0.07 scores on a scale Standard Deviation 0.525
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 24, Mobility	-0.15 scores on a scale Standard Deviation 0.460	-0.08 scores on a scale Standard Deviation 0.549
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 28, Mobility	-0.15 scores on a scale Standard Deviation 0.510	-0.06 scores on a scale Standard Deviation 0.485
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 32, Mobility	-0.17 scores on a scale Standard Deviation 0.537	-0.03 scores on a scale Standard Deviation 0.280
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 36, Mobility	-0.06 scores on a scale Standard Deviation 0.359	-0.04 scores on a scale Standard Deviation 0.331
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 40, Mobility	-0.17 scores on a scale Standard Deviation 0.576	-0.06 scores on a scale Standard Deviation 0.429
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 44, Mobility	-0.19 scores on a scale Standard Deviation 0.680	0.00 scores on a scale Standard Deviation 0.354
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 48, Mobility	-0.28 scores on a scale Standard Deviation 0.669	0.00 scores on a scale Standard Deviation 0.378
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 52, Mobility	-0.29 scores on a scale Standard Deviation 0.470	-0.08 scores on a scale Standard Deviation 0.277
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 14, Self-care	-0.20 scores on a scale Standard Deviation 0.637	-0.03 scores on a scale Standard Deviation 0.413
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 16, Self-care	-0.19 scores on a scale Standard Deviation 0.612	-0.08 scores on a scale Standard Deviation 0.414
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 20, Self-care	-0.10 scores on a scale Standard Deviation 0.775	0.05 scores on a scale Standard Deviation 0.711
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 24, Self-care	-0.12 scores on a scale Standard Deviation 0.615	-0.08 scores on a scale Standard Deviation 0.385
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 28, Self-care	-0.11 scores on a scale Standard Deviation 0.477	-0.09 scores on a scale Standard Deviation 0.408
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 32, Self-care	-0.12 scores on a scale Standard Deviation 0.670	-0.15 scores on a scale Standard Deviation 0.432
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 36, Self-care	0.06 scores on a scale Standard Deviation 0.680	-0.11 scores on a scale Standard Deviation 0.315
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 40, Self-care	-0.04 scores on a scale Standard Deviation 0.367	-0.06 scores on a scale Standard Deviation 0.243
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 44, Self-care	-0.05 scores on a scale Standard Deviation 0.384	0.00 scores on a scale Standard Deviation 0.000
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 48, Self-care	0.00 scores on a scale Standard Deviation 0.485	-0.07 scores on a scale Standard Deviation 0.258
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 52, Self-care	0.00 scores on a scale Standard Deviation 0.354	-0.08 scores on a scale Standard Deviation 0.277
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 14, Usual activities	-0.28 scores on a scale Standard Deviation 0.727	-0.21 scores on a scale Standard Deviation 0.893
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 16, Usual activities	-0.31 scores on a scale Standard Deviation 0.739	-0.21 scores on a scale Standard Deviation 0.744
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 20, Usual activities	-0.25 scores on a scale Standard Deviation 0.968	-0.17 scores on a scale Standard Deviation 0.958
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 24, Usual activities	-0.19 scores on a scale Standard Deviation 0.841	-0.23 scores on a scale Standard Deviation 0.697
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 28, Usual activities	-0.11 scores on a scale Standard Deviation 0.840	-0.21 scores on a scale Standard Deviation 0.623
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 32, Usual activities	-0.26 scores on a scale Standard Deviation 0.767	-0.15 scores on a scale Standard Deviation 0.630
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 36, Usual activities	-0.03 scores on a scale Standard Deviation 0.948	-0.14 scores on a scale Standard Deviation 0.591
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 40, Usual activities	-0.13 scores on a scale Standard Deviation 1.140	0.12 scores on a scale Standard Deviation 0.485
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 44, Usual activities	-0.14 scores on a scale Standard Deviation 0.910	0.06 scores on a scale Standard Deviation 0.429
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 48, Usual activities	-0.28 scores on a scale Standard Deviation 0.958	0.07 scores on a scale Standard Deviation 0.458
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 52, Usual activities	-0.06 scores on a scale Standard Deviation 1.029	0.00 scores on a scale Standard Deviation 0.408
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 14, Pain/discomfort	-1.00 scores on a scale Standard Deviation 1.078	-1.20 scores on a scale Standard Deviation 1.009
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 16, Pain/discomfort	-1.07 scores on a scale Standard Deviation 1.102	-1.13 scores on a scale Standard Deviation 1.055
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 20, Pain/discomfort	-1.15 scores on a scale Standard Deviation 1.102	-1.17 scores on a scale Standard Deviation 1.094
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 24, Pain/discomfort	-1.15 scores on a scale Standard Deviation 0.998	-1.15 scores on a scale Standard Deviation 1.045
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 28, Pain/discomfort	-1.21 scores on a scale Standard Deviation 1.041	-1.21 scores on a scale Standard Deviation 1.062
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 32, Pain/discomfort	-1.02 scores on a scale Standard Deviation 1.000	-1.23 scores on a scale Standard Deviation 1.111
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 36, Pain/discomfort	-0.94 scores on a scale Standard Deviation 1.124	-1.32 scores on a scale Standard Deviation 1.020
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 40, Pain/discomfort	-1.17 scores on a scale Standard Deviation 1.154	-1.00 scores on a scale Standard Deviation 0.791
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 44, Pain/discomfort	-1.05 scores on a scale Standard Deviation 1.284	-1.12 scores on a scale Standard Deviation 0.781
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 48, Pain/discomfort	-1.11 scores on a scale Standard Deviation 1.451	-1.47 scores on a scale Standard Deviation 0.915
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 52, Pain/discomfort	-1.18 scores on a scale Standard Deviation 1.334	-1.15 scores on a scale Standard Deviation 0.899
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 14, Anxiety/depression	-0.51 scores on a scale Standard Deviation 0.921	-0.44 scores on a scale Standard Deviation 0.806
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 16, Anxiety/depression	-0.49 scores on a scale Standard Deviation 0.910	-0.46 scores on a scale Standard Deviation 0.895
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 20, Anxiety/depression	-0.48 scores on a scale Standard Deviation 0.930	-0.43 scores on a scale Standard Deviation 0.819
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 24, Anxiety/depression	-0.54 scores on a scale Standard Deviation 0.999	-0.40 scores on a scale Standard Deviation 0.743
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 28, Anxiety/depression	-0.51 scores on a scale Standard Deviation 0.882	-0.38 scores on a scale Standard Deviation 0.768
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 32, Anxiety/depression	-0.57 scores on a scale Standard Deviation 0.859	-0.33 scores on a scale Standard Deviation 0.955
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 36, Anxiety/depression	-0.48 scores on a scale Standard Deviation 0.811	-0.29 scores on a scale Standard Deviation 0.713
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 40, Anxiety/depression	-0.57 scores on a scale Standard Deviation 0.945	-0.65 scores on a scale Standard Deviation 0.862
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 44, Anxiety/depression	-0.71 scores on a scale Standard Deviation 1.102	-0.71 scores on a scale Standard Deviation 0.920
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 48, Anxiety/depression	-0.83 scores on a scale Standard Deviation 0.985	-0.67 scores on a scale Standard Deviation 0.816
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit Change from Baseline at Week 52, Anxiety/depression	-0.94 scores on a scale Standard Deviation 0.966	-0.54 scores on a scale Standard Deviation 0.877

SECONDARY outcome

Timeframe: up to Week 12

Population: Safety Population: all participants who applied ruxolitinib 1.5% cream or vehicle cream at least once. Treatment groups were determined according to the actual treatment the participant applied on Day 1 regardless of assigned treatment group.

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=95 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	22 Participants	27 Participants

SECONDARY outcome

Timeframe: up to Week 12

Population: Safety Population

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=95 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
DBVC Period: Number of Participants With Any ≥Grade 3 TEAE	1 Participants	1 Participants

SECONDARY outcome

Timeframe: from beginning of Week 13 up to Week 56

Population: Open-label Extension Population

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
OLE Period: Number of Participants With Any TEAE	36 Participants	36 Participants

SECONDARY outcome

Timeframe: from beginning of Week 13 up to Week 56

Population: Open-label Extension Population

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using CTCAE version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.

Outcome measures

Outcome measures
Measure	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=83 Participants Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching.
OLE Period: Number of Participants With Any ≥Grade 3 TEAE	2 Participants	4 Participants

Adverse Events

Vehicle Cream BID

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Ruxolitinib 1.5% Cream BID

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vehicle Cream BID n=94 participants at risk Participants applied vehicle cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period.	Ruxolitinib 1.5% Cream BID n=178 participants at risk Participants applied ruxolitinib 1.5% cream BID to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion for 12 weeks in the DBVC Period and for 40 weeks in the OLE Period. Participants who applied matching vehicle cream BID for 12 weeks during the DBVC Period and completed the Week 12 assessments with no safety concerns applied ruxolitinib 1.5% cream for 40 weeks during the OLE Period.
Cardiac disorders Angina unstable	0.00% 0/94 • up to Week 56 For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.	0.56% 1/178 • Number of events 1 • up to Week 56 For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/94 • up to Week 56 For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.	0.56% 1/178 • Number of events 1 • up to Week 56 For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.
Infections and infestations Erysipelas	0.00% 0/94 • up to Week 56 For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.	0.56% 1/178 • Number of events 1 • up to Week 56 For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.
Infections and infestations Urinary tract infection	0.00% 0/94 • up to Week 56 For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.	0.56% 1/178 • Number of events 1 • up to Week 56 For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.

Other adverse events

Other adverse events
Measure	Vehicle Cream BID n=94 participants at risk Participants applied vehicle cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period.	Ruxolitinib 1.5% Cream BID n=178 participants at risk Participants applied ruxolitinib 1.5% cream BID to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion for 12 weeks in the DBVC Period and for 40 weeks in the OLE Period. Participants who applied matching vehicle cream BID for 12 weeks during the DBVC Period and completed the Week 12 assessments with no safety concerns applied ruxolitinib 1.5% cream for 40 weeks during the OLE Period.
Infections and infestations Upper respiratory tract infection	3.2% 3/94 • Number of events 3 • up to Week 56 For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.	5.6% 10/178 • Number of events 12 • up to Week 56 For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.
Infections and infestations Nasopharyngitis	1.1% 1/94 • Number of events 1 • up to Week 56 For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.	5.1% 9/178 • Number of events 9 • up to Week 56 For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Publication restrictions are in place

Restriction type: OTHER