Trial Outcomes & Findings for Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2) (NCT NCT04202679)
NCT ID: NCT04202679
Last Updated: 2025-09-17
Results Overview
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 12 is reported in this outcome measure.
COMPLETED
PHASE3
160 participants
Baseline, Week 12
2025-09-17
Participant Flow
This study was conducted at 57 sites in 11 countries. A total of 221 participants were screened from 16 January 2020 to 24 February 2021, out of which 61 were screen failures. Screen failures were mainly due to not meeting eligibility criteria.
A total of 160 participants were randomized in 1:1 ratio to receive study interventions (placebo or dupilumab) by interactive response technology (IRT).
Participant milestones
| Measure |
Placebo
Participants received placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (q2w) for 24 weeks added to background therapy of topical corticosteroids/topical calcineurin inhibitors (TCS/TCI) at stable dose.
|
Dupilumab 300 mg Q2W
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
78
|
|
Overall Study
Treated
|
82
|
77
|
|
Overall Study
COMPLETED
|
56
|
72
|
|
Overall Study
NOT COMPLETED
|
26
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (q2w) for 24 weeks added to background therapy of topical corticosteroids/topical calcineurin inhibitors (TCS/TCI) at stable dose.
|
Dupilumab 300 mg Q2W
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Poor compliance to protocol
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
23
|
6
|
Baseline Characteristics
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)
Baseline characteristics by cohort
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=78 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 15.2 • n=93 Participants
|
51.0 years
STANDARD_DEVIATION 15.8 • n=4 Participants
|
48.8 years
STANDARD_DEVIATION 15.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
96 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on intent-to-treat (ITT) population which included all participants with a treatment kit number allocated and recorded in the IRT database analyzed according to the treatment group allocated by randomization regardless of if treatment kit was used or not.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 12 is reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=78 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Percentage of Participants With Greater Than or Equal to (>=) 4 Points Improvement (Reduction) From Baseline in Worst-Itch Numeric Rating Scale (WI-NRS) Scores at Week 12
|
22.0 percentage of participants
|
37.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 24 is reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=78 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Percentage of Participants With >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Week 24
|
19.5 percentage of participants
|
57.7 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 24Population: Analysis was performed on ITT population.
IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=78 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage (IGA PN-S) Scores of 0 or 1 at Week 24
|
15.9 percentage of participants
|
44.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch), higher scores indicated more severity. IGA PN-S assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicated greater severity. Percentage of participants with both an improvement (reduction) in WI-NRS by \>=4 Points (from Baseline) and an IGA PN-S score of 0 or 1 were reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=78 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Percentage of Participants With Both an Improvement (Reduction) in WI-NRS by >=4 Points and an IGA PN-S Score of 0 or 1 From Baseline at Week 24
|
8.5 percentage of participants
|
32.1 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Analysis was performed on ITT population.
IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=78 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Percentage of Participants With IGA PN-S Scores of 0 or 1 at Week 12
|
12.2 percentage of participants
|
25.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Least squares (LS) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=76 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Percent Change From Baseline in WI-NRS Scores at Week 24
|
-36.18 percent change
Standard Error 6.21
|
-59.34 percent change
Standard Error 6.39
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
DLQI is developed to measure dermatology specific HRQoL in adult participants. It comprises of set of 10 questions assessing the impact of skin disease on participants' HRQoL over the previous week. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life. LS means and SE were obtained from ANCOVA model.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=77 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Change From Baseline in Health-related Quality of Life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) at Week 24
|
-6.77 score on a scale
Standard Error 1.18
|
-13.16 score on a scale
Standard Error 1.21
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Skin Pain-NRS was used to measure skin pain intensity. Participants were asked daily to rate the intensity of their worst skin pain over the past 24 hours, using a 11-point scale ranging from 0 ("No pain") to 10 ("Worst possible pain"). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=76 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Change From Baseline in Skin Pain-NRS at Week 24
|
-2.74 score on a scale
Standard Error 0.51
|
-4.35 score on a scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Sleep-NRS was used to measure sleep intensity. Participants were asked to rate their sleep quality on their past night upon awakening, using a 11-point NRS ranging from 0 to 10, where 0 = worst possible sleep and 10 = best possible sleep. Higher scores indicated less severity. LS means and SE were obtained from ANCOVA model.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=76 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Change From Baseline in Sleep-NRS at Week 24
|
0.76 score on a scale
Standard Error 0.45
|
1.30 score on a scale
Standard Error 0.46
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale comprised of 7 items with a scoring range from 0 (less severity of anxiety and depression) to 21 (greater severity of anxiety and depression symptoms) for each subscale. The total HADS score ranges from 0 (less severity) to 42 (more severity), with a high score indicative of a severe anxiety and/or depression level. LS means and SE were obtained from ANCOVA model.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=77 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 24
|
-2.59 score on a scale
Standard Error 1.03
|
-5.55 score on a scale
Standard Error 1.06
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on ITT population.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Probability of participants with an improvement (reduction) in WI-NRS at Week 24 was based on Kaplan-Meier estimates and was reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=78 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Probability of Participants With an Improvement (Reduction) in WI-NRS by >=4 From Baseline at Week 24
|
0.353 probability of participants
Interval 0.25 to 0.457
|
0.670 probability of participants
Interval 0.552 to 0.764
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=77 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Change From Baseline in WI-NRS Scores at Weeks 12 and 24
Week 12
|
-3.04 score on a scale
Standard Error 0.46
|
-4.11 score on a scale
Standard Error 0.47
|
|
Change From Baseline in WI-NRS Scores at Weeks 12 and 24
Week 24
|
-3.10 score on a scale
Standard Error 0.53
|
-5.05 score on a scale
Standard Error 0.54
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4 and 12Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.
Outcome measures
| Measure |
Placebo
n=81 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=77 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 2, 4 and 12
Week 12
|
-35.83 percent change
Standard Error 5.42
|
-48.86 percent change
Standard Error 5.59
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 2, 4 and 12
Week 2
|
-15.61 percent change
Standard Error 3.06
|
-17.41 percent change
Standard Error 3.15
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 2, 4 and 12
Week 4
|
-22.61 percent change
Standard Error 4.00
|
-30.09 percent change
Standard Error 4.12
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24Population: Analysis was performed on ITT population. Here, 'number analyzed' = participants with available data for each specified category.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=78 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 1
|
-9.49 percent change
Standard Error 2.12
|
-8.66 percent change
Standard Error 2.18
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 2
|
-15.61 percent change
Standard Error 3.06
|
-17.41 percent change
Standard Error 3.15
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 3
|
-20.44 percent change
Standard Error 3.66
|
-25.26 percent change
Standard Error 3.77
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 4
|
-22.61 percent change
Standard Error 4.00
|
-30.09 percent change
Standard Error 4.12
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 5
|
-25.21 percent change
Standard Error 4.21
|
-34.41 percent change
Standard Error 4.33
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 7
|
-28.99 percent change
Standard Error 4.69
|
-39.30 percent change
Standard Error 4.84
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 8
|
-30.45 percent change
Standard Error 4.56
|
-41.32 percent change
Standard Error 4.70
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 9
|
-34.86 percent change
Standard Error 4.89
|
-47.08 percent change
Standard Error 5.04
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 10
|
-32.90 percent change
Standard Error 5.04
|
-44.65 percent change
Standard Error 5.20
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 11
|
-34.64 percent change
Standard Error 5.25
|
-45.98 percent change
Standard Error 5.41
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 12
|
-35.83 percent change
Standard Error 5.42
|
-48.86 percent change
Standard Error 5.59
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 13
|
-34.49 percent change
Standard Error 5.69
|
-48.32 percent change
Standard Error 5.86
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 14
|
-36.60 percent change
Standard Error 5.71
|
-50.67 percent change
Standard Error 5.88
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 15
|
-35.96 percent change
Standard Error 5.74
|
-51.89 percent change
Standard Error 5.91
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 16
|
-37.80 percent change
Standard Error 5.74
|
-54.36 percent change
Standard Error 5.91
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 17
|
-39.15 percent change
Standard Error 5.98
|
-55.95 percent change
Standard Error 6.15
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 18
|
-40.38 percent change
Standard Error 6.15
|
-56.80 percent change
Standard Error 6.32
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 19
|
-40.03 percent change
Standard Error 6.05
|
-57.75 percent change
Standard Error 6.23
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 20
|
-36.12 percent change
Standard Error 5.94
|
-56.80 percent change
Standard Error 6.10
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 21
|
-36.43 percent change
Standard Error 6.16
|
-56.91 percent change
Standard Error 6.34
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 22
|
-37.34 percent change
Standard Error 6.19
|
-58.78 percent change
Standard Error 6.33
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 23
|
-36.87 percent change
Standard Error 6.19
|
-59.43 percent change
Standard Error 6.32
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 24
|
-36.18 percent change
Standard Error 6.21
|
-59.34 percent change
Standard Error 6.39
|
|
Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 6
|
-27.87 percent change
Standard Error 4.33
|
-36.98 percent change
Standard Error 4.46
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Analysis was performed on ITT population.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with improvement (Reduction) in WI-NRS scale by \>=4 Points at Week 4 is reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=78 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Percentage of Participants With Improvement (Reduction) in WI-NRS >=4 Points From Baseline at Week 4
|
7.3 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24Population: Analysis was performed on ITT population.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants achieving \>=4 points improvement (reduction) from Baseline in WI-NRS scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 is reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=78 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 1
|
1.2 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 2
|
1.2 percentage of participants
|
5.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 3
|
6.1 percentage of participants
|
12.8 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 4
|
7.3 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 5
|
4.9 percentage of participants
|
17.9 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 6
|
13.4 percentage of participants
|
23.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 7
|
15.9 percentage of participants
|
24.4 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 8
|
14.6 percentage of participants
|
28.2 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 9
|
24.4 percentage of participants
|
32.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 10
|
18.3 percentage of participants
|
32.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 11
|
17.1 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 12
|
22.0 percentage of participants
|
37.2 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 13
|
19.5 percentage of participants
|
39.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 14
|
22.0 percentage of participants
|
39.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 15
|
20.7 percentage of participants
|
44.9 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 16
|
19.5 percentage of participants
|
44.9 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 17
|
23.2 percentage of participants
|
47.4 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 18
|
24.4 percentage of participants
|
48.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 19
|
23.2 percentage of participants
|
51.3 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 20
|
20.7 percentage of participants
|
51.3 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 21
|
20.7 percentage of participants
|
48.7 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 22
|
22.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 23
|
20.7 percentage of participants
|
55.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Week 24
|
19.5 percentage of participants
|
57.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Onset of action was defined as the first p\<0.05 difference from placebo in the weekly average WI-NRS that remained significant at subsequent measurements. WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated greater severity.
Outcome measures
| Measure |
Placebo
n=81 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=77 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Onset of Action Based on Change From Baseline in WI-NRS at Week 4
|
-1.94 score on a scale
Standard Error 0.33
|
-2.55 score on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: At Weeks 4 and 8Population: Analysis was performed on ITT population.
IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=78 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment for PN-Stage (IGA PN-S) Score of 0 or 1 at Weeks 4 and 8
Week 4
|
6.1 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment for PN-Stage (IGA PN-S) Score of 0 or 1 at Weeks 4 and 8
Week 8
|
9.8 percentage of participants
|
15.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, and 24Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.
IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. LS means and SE were obtained from ANCOVA model.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=77 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Change From Baseline in IGA PN-S Scores at Weeks 4, 8, 12, and 24
Week 4
|
-0.54 score on a scale
Standard Error 0.13
|
-0.69 score on a scale
Standard Error 0.13
|
|
Change From Baseline in IGA PN-S Scores at Weeks 4, 8, 12, and 24
Week 8
|
-0.79 score on a scale
Standard Error 0.17
|
-1.19 score on a scale
Standard Error 0.17
|
|
Change From Baseline in IGA PN-S Scores at Weeks 4, 8, 12, and 24
Week 12
|
-0.86 score on a scale
Standard Error 0.18
|
-1.47 score on a scale
Standard Error 0.18
|
|
Change From Baseline in IGA PN-S Scores at Weeks 4, 8, 12, and 24
Week 24
|
-1.07 score on a scale
Standard Error 0.20
|
-2.03 score on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 12 and 24Population: Analysis was performed on ITT population.
The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear (0% nodules showing excoriations/crusts), 1 = almost clear (up to 10% nodules showing excoriations/crusts), 2 = mild (11-25% nodules showing excoriations/crusts), 3 = moderate (26-75% nodules showing excoriations/crusts) and 4 = severe (76-100% of nodules showing excoriations/crusts). Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-A score of either 0 (clear) or 1 (almost clear) has been reported.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=78 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment for PN-Activity (IGA PN-A) Score of 0 or 1 at Weeks 4, 8, 12 and 24
Week 4
|
4.9 percentage of participants
|
14.1 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment for PN-Activity (IGA PN-A) Score of 0 or 1 at Weeks 4, 8, 12 and 24
Week 8
|
15.9 percentage of participants
|
23.1 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment for PN-Activity (IGA PN-A) Score of 0 or 1 at Weeks 4, 8, 12 and 24
Week 12
|
19.5 percentage of participants
|
42.3 percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment for PN-Activity (IGA PN-A) Score of 0 or 1 at Weeks 4, 8, 12 and 24
Week 24
|
18.3 percentage of participants
|
51.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
DLQI is developed to measure dermatology specific HRQoL in adult participants. It comprises of set of 10 questions assessing the impact of skin disease on participants' HRQoL over the previous week. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life. LS means and SE were obtained from ANCOVA model.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=77 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Change From Baseline in HRQoL, as Measured by DLQI at Week 12
|
-7.05 score on a scale
Standard Error 1.12
|
-12.07 score on a scale
Standard Error 1.16
|
SECONDARY outcome
Timeframe: From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)Population: Analysis was performed on safety population which included all participants who received at least 1 dose of study intervention analyzed according to the intervention actually received.
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the treatment-emergent (TE) period (time from the first investigational medicinal product \[IMP\] administration to the last IMP administration + 14 weeks).
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=77 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
47 Participants
|
47 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)Population: Analysis was performed on ADA population which included all participants who received at least one dose of the study drug and had at least one non-missing ADA result after first dose of study drug. Participants were analyzed according to the intervention actually received.
ADA response was categorized as: Treatment emergent and Treatment-boosted. Treatment emergent ADAs were defined as a participant with no positive assay response at baseline but with a positive assay response during the entire TEAE period. Treatment boosted ADAs: defined as participants with a positive ADA assay response at baseline and with at least a 4-fold increase in titer compared to baseline during the TE period (time from the first IMP administration to the last IMP administration + 14 weeks). Titer values were defined as low titer (\< 1,000); moderate (1,000 \<= titer \<= 10,000) and high titer (\> 10,000).
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=76 Participants
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Number of Participants With Treatment-emergent and Treatment Boosted Antidrug Antibodies (ADA)
Treatment-emergent ADAs
|
1 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent and Treatment Boosted Antidrug Antibodies (ADA)
Treatment-boosted ADAs
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Dupilumab 300 mg Q2W
Serious adverse events
| Measure |
Placebo
n=82 participants at risk
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=77 participants at risk
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Infections and infestations
Pelvic Inflammatory Disease
|
0.00%
0/82 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
1.3%
1/77 • Number of events 1 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/82 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
1.3%
1/77 • Number of events 1 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous T-Cell Lymphoma
|
1.2%
1/82 • Number of events 1 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
0.00%
0/77 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large Granular Lymphocytosis
|
1.2%
1/82 • Number of events 1 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
0.00%
0/77 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/82 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
1.3%
1/77 • Number of events 1 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/82 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
1.3%
1/77 • Number of events 1 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
|
Nervous system disorders
Cauda Equina Syndrome
|
1.2%
1/82 • Number of events 1 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
0.00%
0/77 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
1.2%
1/82 • Number of events 1 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
0.00%
0/77 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
1.2%
1/82 • Number of events 1 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
0.00%
0/77 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
Other adverse events
| Measure |
Placebo
n=82 participants at risk
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
Dupilumab 300 mg Q2W
n=77 participants at risk
Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/82 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
5.2%
4/77 • Number of events 4 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
6.1%
5/82 • Number of events 9 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
5.2%
4/77 • Number of events 4 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
6.1%
5/82 • Number of events 5 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
5.2%
4/77 • Number of events 4 • From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER