A Phase 3 interventional study of Dupilumab SAR231893 and Placebo in Neurodermatitis, sponsored by Sanofi. Completed at 63 sites in 8 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Primary Objective:
To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapies or when those therapies are not advisable.
Secondary Objectives:
To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapies or when those therapies are not advisable.
To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.
The duration of study for each participant included 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period.
22 studies on the registry are indexed under Neurodermatitis; 3 are open to participants now.
This study's enrollment of 151 is above the median of 44 across 22 interventional studies indexed under Neurodermatitis.
Browse Neurodermatitis studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must be 18 to 80 years of age, at the time of signing the .
With a clinical diagnosis of PN defined by all of the following:
Exclusion Criteria:
Participants were excluded from the study if any of the following criteria apply:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received dupilumab at a loading dose of 600 milligrams (mg), subcutaneously (SC) on Day 1 followed by 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.
Drug: Dupilumab SAR231893 · Drug: Moisturizers · Drug: Low to medium potent topical corticosteroids · Drug: Topical calcineurin inhibitors
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.
Drug: Placebo · Drug: Moisturizers · Drug: Low to medium potent topical corticosteroids · Drug: Topical calcineurin inhibitors
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Pharmaceutical form: Route of administration: Topical
Pharmaceutical form: Route of administration: Topical
Pharmaceutical form: Route of administration: Topical
Percentage of Participants With Improvement (Reduction) in Worst Itch Numeric Rating Scale (WI-NRS) Scores by Greater Than or Equal to (>=) 4 Points From Baseline to Week 24
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 scores by \>=4 points from Baseline to Week 24 is reported in this outcome measure.
Time frame: Baseline, Week 24
Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage (IGA PN-S) Scores of 0 or 1 at Week 24
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 (PN). In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.
Time frame: At Week 24
Percentage of Participants With Both an Improvement (Reduction) in WI-NRS Scores by >=4 Points and an IGA PN-S Scores of 0 or 1 From Baseline at Week 24
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 scores by \>=4 points (from Baseline) and an IGA PN-S scores of 0 or 1 were reported in this outcome measure.
Time frame: Baseline, Week 24
Percent Change From Baseline in WI-NRS Scores at Week 24
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) mean and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model.
Time frame: Baseline, Week 24
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) at Week 24
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.
Time frame: Baseline, Week 24
Change From Baseline in Skin Pain-NRS at Week 24
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.
Time frame: Baseline, Week 24
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 24
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 severe anxiety and/or depression level. LS means and SE were obtained from ANCOVA model.
Time frame: Baseline, Week 24
Probability of Participants With an Improvement (Reduction) in WI-NRS Scores by >=4 Points From Baseline at Week 24
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.
Time frame: Baseline, Week 24
Change From Baseline in WI-NRS Scores at Week 12 and 24
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.
Time frame: Baseline, Weeks 12 and 24
Percent Change From Baseline in WI-NRS Scores at Weeks 2, 4 and 12
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.
Time frame: Baseline, Weeks 2, 4 and 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
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.
Time frame: 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 24
Percentage of Participants With Improvement (Reduction) in WI-NRS Scores by >=4 Points From Baseline at Week 12
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 score by \>=4 points from Baseline to Week 12 is reported in this outcome measure.
Time frame: Baseline, Week 12
Percentage of Participants With Improvement (Reduction) in WI-NRS Scores by >=4 Points From Baseline at Week 4
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 scores by \>=4 Points at Week 4 is reported in this outcome measure.
Time frame: Baseline, Week 4
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
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.
Time frame: 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 24
Onset of Action Based on Change From Baseline in WI-NRS Scores at Week 3
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. LS means and SE were obtained from ANCOVA model.
Time frame: Baseline, Week 3
Percentage of Participants With Investigator's Global Assessment for PN-Stage (IGA PN-S) 0 or 1 Score at Weeks 4, 8, and 12
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 PN. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.
Time frame: At Weeks 4, 8 and 12
Change From Baseline in IGA PN-S Scores at Weeks 4, 8, 12, and 24
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 PN. LS means and SE were obtained from ANCOVA model.
Time frame: Baseline, Weeks 4, 8, 12, and 24
Percentage of Participants With Investigator's Global Assessment for PN-Activity (IGA PN-A) 0 or 1 Score at Weeks 4, 8, 12 and 24
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 PN. In this outcome measure, percentage of participants with IGA PN-A score of either 0 (clear) or 1 (almost clear) has been reported.
Time frame: At Weeks 4, 8, 12 and 24
Change From Baseline in HRQoL as Measured by DLQI at Week 12
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.
Time frame: Baseline, Week 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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 (from the first investigational medicinal product \[IMP\] administration to the last IMP administration + 14 weeks).
Time frame: From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Number of Participants With Treatment-emergent and Treatment Boosted Antidrug Antibodies (ADA)
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).
Time frame: From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
This study was conducted at 58 active sites in 8 countries. A total of 200 participants were screened from 12 December 2019 to 11 May 2021, out of which 49 were screen failures. Screen failures were mainly due to not meeting eligibility criteria.
| Milestone | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Started | 76 | 75 |
| Treated | 75 | 75 |
| Completed | 63 | 72 |
| Not completed | 13 | 3 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 12 | 3 |
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 scores by \>=4 points from Baseline to Week 24 is reported in this outcome measure.
| percentage of participants | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Percentage of Participants With Improvement (Reduction) in Worst Itch Numeric Rating Scale (WI-NRS) Scores by Greater Than or Equal to (>=) 4 Points From Baseline to Week 24 | 18.4 | 60.0 |
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 (PN). In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.
| percentage of participants | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage (IGA PN-S) Scores of 0 or 1 at Week 24 | 18.4 | 48.0 |
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 scores by \>=4 points (from Baseline) and an IGA PN-S scores of 0 or 1 were reported in this outcome measure.
| percentage of participants | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Percentage of Participants With Both an Improvement (Reduction) in WI-NRS Scores by >=4 Points and an IGA PN-S Scores of 0 or 1 From Baseline at Week 24 | 9.2 | 38.7 |
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) mean and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model.
| percent change | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Percent Change From Baseline in WI-NRS Scores at Week 24 | -22.22 ± 5.74 | -48.89 ± 5.61 |
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.
| score on a scale | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) at Week 24 | -5.77 ± 1.05 | -11.97 ± 1.02 |
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.
| score on a scale | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Change From Baseline in Skin Pain-NRS at Week 24 | -2.16 ± 0.44 | -4.33 ± 0.43 |
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 severe anxiety and/or depression level. LS means and SE were obtained from ANCOVA model.
| score on a scale | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 24 | -2.02 ± 0.94 | -4.62 ± 0.93 |
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.
| probability of participants | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Probability of Participants With an Improvement (Reduction) in WI-NRS Scores by >=4 Points From Baseline at Week 24 | 0.363 (0.253 to 0.473) | 0.667 (0.548 to 0.761) |
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.
| score on a scale | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Week 12 | -1.84 ± 0.38 | -3.87 ± 0.38 |
| Week 24 | -2.28 ± 0.43 | -4.56 ± 0.42 |
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.
| percent change | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Week 2 | -7.98 ± 3.70 | -13.57 ± 3.64 |
| Week 4 | -9.09 ± 4.07 | -22.23 ± 4.00 |
| Week 12 | -17.05 ± 5.31 | -41.05 ± 5.21 |
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.
| percent change | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Week 1 | -5.77 ± 2.24 | -6.68 ± 2.21 |
| Week 2 | -7.98 ± 3.70 | -13.57 ± 3.64 |
| Week 3 | -9.27 ± 3.92 | -17.67 ± 3.86 |
| Week 4 | -9.09 ± 4.07 | -22.23 ± 4.00 |
| Week 5 | -8.49 ± 4.43 | -23.87 ± 4.36 |
| Week 6 | -10.56 ± 4.79 | -26.94 ± 4.71 |
| Week 7 | -12.22 ± 5.02 | -29.20 ± 4.93 |
| Week 8 | -13.78 ± 5.06 | -32.51 ± 4.97 |
| Week 9 | -15.34 ± 5.14 | -34.26 ± 5.03 |
| Week 10 | -16.32 ± 5.12 | -36.96 ± 5.00 |
| Week 11 | -16.71 ± 5.35 | -38.06 ± 5.22 |
| Week 12 | -17.05 ± 5.31 | -41.05 ± 5.21 |
| Week 13 | -17.66 ± 5.35 | -41.23 ± 5.26 |
| Week 14 | -18.64 ± 5.40 | -40.55 ± 5.30 |
| Week 15 | -19.69 ± 5.51 | -42.37 ± 5.42 |
| Week 16 | -18.10 ± 5.54 | -43.29 ± 5.44 |
| Week 17 | -19.06 ± 5.62 | -42.33 ± 5.52 |
| Week 18 | -19.93 ± 5.75 | -43.27 ± 5.65 |
| Week 19 | -20.99 ± 5.80 | -43.35 ± 5.69 |
| Week 20 | -19.90 ± 5.83 | -43.79 ± 5.72 |
| Week 21 | -20.51 ± 5.80 | -44.85 ± 5.69 |
| Week 22 | -23.30 ± 5.90 | -44.84 ± 5.78 |
| Week 23 | -23.08 ± 5.79 | -48.65 ± 5.68 |
| Week 24 | -22.22 ± 5.74 | -48.89 ± 5.61 |
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 score by \>=4 points from Baseline to Week 12 is reported in this outcome measure.
| percentage of participants | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Percentage of Participants With Improvement (Reduction) in WI-NRS Scores by >=4 Points From Baseline at Week 12 | 15.8 | 44.0 |
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 scores by \>=4 Points at Week 4 is reported in this outcome measure.
| percentage of participants | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Percentage of Participants With Improvement (Reduction) in WI-NRS Scores by >=4 Points From Baseline at Week 4 | 3.9 | 18.7 |
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.
| percentage of participants | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Week 1 | 0 | 4.0 |
| Week 2 | 2.6 | 10.7 |
| Week 3 | 3.9 | 12.0 |
| Week 4 | 3.9 | 18.7 |
| Week 5 | 5.3 | 21.3 |
| Week 6 | 6.6 | 33.3 |
| Week 7 | 7.9 | 29.3 |
| Week 8 | 10.5 | 33.3 |
| Week 9 | 13.2 | 38.7 |
| Week 10 | 10.5 | 40.0 |
| Week 11 | 14.5 | 44.0 |
| Week 12 | 15.8 | 44.0 |
| Week 13 | 13.2 | 50.7 |
| Week 14 | 19.7 | 45.3 |
| Week 15 | 18.4 | 52.0 |
| Week 16 | 17.1 | 50.7 |
| Week 17 | 21.1 | 50.7 |
| Week 18 | 21.1 | 54.7 |
| Week 19 | 22.4 | 54.7 |
| Week 20 | 21.1 | 54.7 |
| Week 21 | 18.4 | 56.0 |
| Week 22 | 22.4 | 56.0 |
| Week 23 | 19.7 | 58.7 |
| Week 24 | 18.4 | 60.0 |
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. LS means and SE were obtained from ANCOVA model.
| score on a scale | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Onset of Action Based on Change From Baseline in WI-NRS Scores at Week 3 | -1.10 ± 0.27 | -1.80 ± 0.26 |
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 PN. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.
| percentage of participants | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Week 4 | 1.3 | 9.3 |
| Week 8 | 3.9 | 16.0 |
| Week 12 | 11.8 | 32.0 |
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 PN. LS means and SE were obtained from ANCOVA model.
| score on a scale | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Week 4 | -0.15 ± 0.10 | -0.44 ± 0.10 |
| Week 8 | -0.29 ± 0.13 | -0.79 ± 0.13 |
| Week 12 | -0.52 ± 0.15 | -1.13 ± 0.15 |
| Week 24 | -0.62 ± 0.17 | -1.59 ± 0.17 |
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 PN. In this outcome measure, percentage of participants with IGA PN-A score of either 0 (clear) or 1 (almost clear) has been reported.
| percentage of participants | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Week 4 | 3.9 | 10.7 |
| Week 8 | 3.9 | 22.7 |
| Week 12 | 14.5 | 34.7 |
| Week 24 | 19.7 | 60.0 |
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.
| score on a scale | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Change From Baseline in HRQoL as Measured by DLQI at Week 12 | -5.67 ± 0.90 | -10.95 ± 0.89 |
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 (from the first investigational medicinal product \[IMP\] administration to the last IMP administration + 14 weeks).
| Participants | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| TEAEs | 47 | 53 |
| TESAEs | 8 | 5 |
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).
| Participants | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Treatment-emergent ADAs | 3 | 8 |
| Treatment-boosted ADAs | 0 | 0 |
Collected over From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/75 (0%) | 8/75 (10.7%) | 15/75 (20%) |
| Dupilumab 300 mg Q2W | 0/75 (0%) | 5/75 (6.7%) | 14/75 (18.7%) |
| Event | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| Acute Myocardial InfarctionCardiac disorders | 2/75 | 0/75 |
| Covid-19Infections and infestations | 1/75 | 0/75 |
| Covid-19 PneumoniaInfections and infestations | 0/75 | 1/75 |
| SepsisInfections and infestations | 1/75 | 0/75 |
| Hodgkin's DiseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/75 | 0/75 |
| Papillary Thyroid CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/75 | 1/75 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/75 | 1/75 |
| Interstitial Lung DiseaseRespiratory, thoracic and mediastinal disorders | 0/75 | 1/75 |
| Duodenal Ulcer PerforationGastrointestinal disorders | 1/75 | 0/75 |
| Inflammatory Bowel DiseaseGastrointestinal disorders | 1/75 | 0/75 |
| Event | Placebo | Dupilumab 300 mg Q2W |
|---|---|---|
| NeurodermatitisSkin and subcutaneous tissue disorders | 7/75 | 2/75 |
| Accidental OverdoseInjury, poisoning and procedural complications | 2/75 | 5/75 |
| NasopharyngitisInfections and infestations | 3/75 | 4/75 |
| HeadacheNervous system disorders | 4/75 | 4/75 |
Analysis was performed on randomized population.
| Age, Continuous(years) | Placebo | Dupilumab 300 mg Q2W | Total |
|---|---|---|---|
| Mean | 51.1 ± 15.8 | 49.2 ± 17.4 | 50.1 ± 16.6 |
| Sex: Female, Male(Participants) | Placebo | Dupilumab 300 mg Q2W | Total |
|---|---|---|---|
| Female | 48 | 52 | 100 |
| Male | 28 | 23 | 51 |
| Race (NIH/OMB)(Participants) | Placebo | Dupilumab 300 mg Q2W | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 3 | 5 |
| Asian | 25 | 29 | 54 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 8 | 11 |
| White | 45 | 35 | 80 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Studies of the drug tested here: Dupilumab