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CompletedNCT04202679Updated Sep 17, 2025Results posted

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)

A Phase 3 interventional study of Dupilumab SAR231893 and Placebo in Neurodermatitis, sponsored by Sanofi. Completed at 57 sites in 11 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

Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Primary Objective:

To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapy 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 therapy 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.

Read the detailed description

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.

02

Conditions studied

  • Neurodermatitis

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03

In context

Neurodermatitis

22 studies on the registry are indexed under Neurodermatitis; 3 are open to participants now.

This study's enrollment of 160 is above the median of 44 across 22 interventional studies indexed under Neurodermatitis.

Browse Neurodermatitis studies →

Lead sponsor

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.

Browse Sanofi studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

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:

  • Diagnosed by a dermatologist for at least 3 months before the Screening visit.
  • On the Worst Itch Numeric Rating Scale (WI-NRS) ranging from 0 to 10, participants must have an average worst itch score of >=7 in the 7 days prior to Day1.
  • Participants must have a minimum of 20 PN lesions in total on both legs, and/or both arms and/or trunk, at Screening visit and Day 1
  • History of failing a 2-week course of medium-to-superpotent topical (TCS) or when TCS are not medically advisable
  • Have applied a stable dose of topical emollient (moisturizer) once or twice daily for at least 5 out of the 7 consecutive days immediately before Day 1.

Must be willing and able to complete a daily symptom eDiary for the duration of the study.

Exclusion criteria

Exclusion criteria:

Participants were excluded from the study if any of the following criteria apply:

  • Presence of skin morbidities other than PN and mild atopic dermatitis that may interfere with the assessment of the study outcomes.
  • PN secondary to medications.
  • PN secondary to medical conditions such as neuropathy or psychiatric disease.
  • Within 6 months before the screening visit, or documented diagnosis of moderate to severe atopic dermatitis from screening visit to randomization visit.
  • Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the participant's participation in the study.
  • Severe renal conditions (eg, participants with uremia and/or on dialysis).
  • Participants with uncontrolled thyroid disease.
  • Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
  • Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization.
  • Active chronic or acute infection (except ) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit and during the screening period.
  • Known or suspected immunodeficiency.
  • Active or history of malignancy within 5 years before the Baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non- squamous or basal cell carcinoma of the skin.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Terms in these criteria, in plain language(5)

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.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • Placebo comparator
    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.

    Drug: Placebo · Drug: Moisturizers · Drug: Low to medium potent topical corticosteroids · Drug: Topical calcineurin inhibitors

  • Experimental
    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.

    Drug: Dupilumab SAR231893 · Drug: Moisturizers · Drug: Low to medium potent topical corticosteroids · Drug: Topical calcineurin inhibitors

Interventions

  • DrugDupilumab SAR231893

    Pharmaceutical form:Injection solution Route of administration: Subcutaneous

  • DrugPlacebo

    Pharmaceutical form:Injection solution Route of administration: Subcutaneous

  • DrugMoisturizers

    Pharmaceutical form: Route of administration: Topical

  • DrugLow to medium potent topical corticosteroids

    Pharmaceutical form: Route of administration: Topical

  • DrugTopical calcineurin inhibitors

    Pharmaceutical form: Route of administration: Topical

06

What researchers measure

Primary outcomes

  1. 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

    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.

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Percentage of Participants With >=4 Points Improvement (Reduction) 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. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 24 is reported in this outcome measure.

    Time frame: Baseline, Week 24

  2. 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. 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

  3. 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

    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.

    Time frame: Baseline, Week 24

  4. Percentage of Participants With IGA PN-S Scores of 0 or 1 at Week 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 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.

    Time frame: At Week 12

  5. 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) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model.

    Time frame: Baseline, Week 24

  6. 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

  7. 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

  8. Change From Baseline in Sleep-NRS at Week 24

    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.

    Time frame: Baseline, Week 24

  9. 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 a severe anxiety and/or depression level. LS means and SE were obtained from ANCOVA model.

    Time frame: Baseline, Week 24

  10. Probability of Participants With an Improvement (Reduction) in WI-NRS by >=4 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

  11. Change From Baseline in WI-NRS Scores at Weeks 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

  12. 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

  13. 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

  14. Percentage of Participants With Improvement (Reduction) in WI-NRS >=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 scale by \>=4 Points at Week 4 is reported in this outcome measure.

    Time frame: Baseline, Week 4

  15. 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

  16. Onset of Action Based on Change From Baseline in WI-NRS at Week 4

    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.

    Time frame: Baseline, Week 4

  17. Percentage of Participants With Investigator's Global Assessment for PN-Stage (IGA PN-S) Score of 0 or 1 at Weeks 4 and 8

    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.

    Time frame: At Weeks 4 and 8

  18. 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 prurigo nodularis. LS means and SE were obtained from ANCOVA model.

    Time frame: Baseline, Weeks 4, 8, 12, and 24

  19. 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

    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.

    Time frame: At Weeks 4, 8, 12 and 24

  20. 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

  21. 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 (time 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)

  22. 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)

07

Results

Posted Sep 28, 2022

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.

Participant flow — Overall Study
MilestonePlaceboDupilumab 300 mg Q2W
Started8278
Treated8277
Completed5672
Not completed266
Withdrew: Adverse event20
Withdrew: Poor compliance to protocol10
Withdrew: Withdrawal by subject236

Outcome measures

PrimaryPercentage 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

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.

Time frame:
Baseline, Week 12
Reported as:
Number · percentage of participants
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
percentage of participantsPlaceboDupilumab 300 mg Q2W
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 1222.037.2
Statistical analysis
  • Placebo vs Dupilumab 300 mg Q2W · Cochran-Mantel-Haenszel · p = 0.0216 (Threshold of significance at 0.05 level.) · Odds ratio (or): 2.3 · 95% CI 1.08 to 5.00Dupilumab 300 mg q2w versus Placebo
SecondaryPercentage of Participants With >=4 Points Improvement (Reduction) 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. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 24 is reported in this outcome measure.

Time frame:
Baseline, Week 24
Reported as:
Number · percentage of participants
Percentage of Participants With >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Week 24
percentage of participantsPlaceboDupilumab 300 mg Q2W
Percentage of Participants With >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Week 2419.557.7
Statistical analysis
  • Placebo vs Dupilumab 300 mg Q2W · Cochran-Mantel-Haenszel · p = <0.0001 (Threshold of significance at 0.05 level.) · Odds ratio (or): 9.0 · 95% CI 3.56 to 22.66Dupilumab 300 mg q2w versus Placebo
SecondaryPercentage 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. 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
Reported as:
Number · percentage of participants
Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage (IGA PN-S) Scores of 0 or 1 at Week 24
percentage of participantsPlaceboDupilumab 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 2415.944.9
Statistical analysis
  • Placebo vs Dupilumab 300 mg Q2W · Cochran-Mantel-Haenszel · p = <0.0001 (Threshold of significance at 0.05 level.) · Odds ratio (or): 4.4 · 95% CI 2.02 to 9.55Dupilumab 300 mg q2w versus Placebo
SecondaryPercentage 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

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.

Time frame:
Baseline, Week 24
Reported as:
Number · percentage of participants
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
percentage of participantsPlaceboDupilumab 300 mg Q2W
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 248.532.1
Statistical analysis
  • Placebo vs Dupilumab 300 mg Q2W · Cochran-Mantel-Haenszel · p = 0.0001 (Threshold of significance at 0.05 level.) · Odds ratio (or): 6.1 · 95% CI 2.03 to 18.11Dupilumab 300 mg q2w versus Placebo
SecondaryPercentage of Participants With IGA PN-S Scores of 0 or 1 at Week 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 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.

Time frame:
At Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With IGA PN-S Scores of 0 or 1 at Week 12
percentage of participantsPlaceboDupilumab 300 mg Q2W
Percentage of Participants With IGA PN-S Scores of 0 or 1 at Week 1212.225.6
Statistical analysis
  • Placebo vs Dupilumab 300 mg Q2W · Cochran-Mantel-Haenszel · p = 0.0194 (Threshold of significance at 0.05 level.) · Odds ratio (or): 2.9 · 95% CI 1.13 to 7.52Dupilumab 300 mg q2w versus Placebo
SecondaryPercent 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) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model.

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · percent change
Percent Change From Baseline in WI-NRS Scores at Week 24
percent changePlaceboDupilumab 300 mg Q2W
Percent Change From Baseline in WI-NRS Scores at Week 24-36.18 ± 6.21-59.34 ± 6.39
Statistical analysis
  • Placebo vs Dupilumab 300 mg Q2W · ANCOVA · p = <0.0001 (Threshold of significance at 0.05 level.) · Ls mean difference: -23.16 · 95% CI -33.81 to -12.51Dupilumab 300 mg q2w versus Placebo
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline in Health-related Quality of Life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) at Week 24
score on a scalePlaceboDupilumab 300 mg Q2W
Change From Baseline in Health-related Quality of Life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) at Week 24-6.77 ± 1.18-13.16 ± 1.21
Statistical analysis
  • Placebo vs Dupilumab 300 mg Q2W · ANCOVA · p = <0.0001 (Threshold of significance at 0.05 level.) · Ls mean difference: -6.39 · 95% CI -8.42 to -4.36Dupilumab 300 mg q2w versus Placebo
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline in Skin Pain-NRS at Week 24
score on a scalePlaceboDupilumab 300 mg Q2W
Change From Baseline in Skin Pain-NRS at Week 24-2.74 ± 0.51-4.35 ± 0.53
Statistical analysis
  • Placebo vs Dupilumab 300 mg Q2W · ANCOVA · p = 0.0003 (Threshold of significance at 0.05 level.) · Ls mean difference: -1.61 · 95% CI -2.49 to -0.73Dupilumab 300 mg q2w versus Placebo
SecondaryChange From Baseline in Sleep-NRS at Week 24

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.

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · score on a scale
Change From Baseline in Sleep-NRS at Week 24
score on a scalePlaceboDupilumab 300 mg Q2W
Change From Baseline in Sleep-NRS at Week 240.76 ± 0.451.30 ± 0.46
Statistical analysis
  • Placebo vs Dupilumab 300 mg Q2W · ANCOVA · p = 0.1658 (Threshold of significance at 0.05 level.) · Ls mean difference: 0.54 · 95% CI -0.22 to 1.30Dupilumab 300 mg q2w versus Placebo
SecondaryChange 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 a severe anxiety and/or depression level. LS means and SE were obtained from ANCOVA model.

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · score on a scale
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 24
score on a scalePlaceboDupilumab 300 mg Q2W
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 24-2.59 ± 1.03-5.55 ± 1.06
SecondaryProbability of Participants With an Improvement (Reduction) in WI-NRS by >=4 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
Reported as:
Number · probability of participants
Probability of Participants With an Improvement (Reduction) in WI-NRS by >=4 From Baseline at Week 24
probability of participantsPlaceboDupilumab 300 mg Q2W
Probability of Participants With an Improvement (Reduction) in WI-NRS by >=4 From Baseline at Week 240.353 (0.250 to 0.457)0.670 (0.552 to 0.764)
SecondaryChange From Baseline in WI-NRS Scores at Weeks 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
Reported as:
Least squares mean · score on a scale
Change From Baseline in WI-NRS Scores at Weeks 12 and 24
score on a scalePlaceboDupilumab 300 mg Q2W
Week 12-3.04 ± 0.46-4.11 ± 0.47
Week 24-3.10 ± 0.53-5.05 ± 0.54
SecondaryPercent 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
Reported as:
Least squares mean · percent change
Percent Change From Baseline in WI-NRS Scores at Weeks 2, 4 and 12
percent changePlaceboDupilumab 300 mg Q2W
Week 2-15.61 ± 3.06-17.41 ± 3.15
Week 4-22.61 ± 4.00-30.09 ± 4.12
Week 12-35.83 ± 5.42-48.86 ± 5.59
SecondaryPercent 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
Reported as:
Least squares mean · percent change
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
percent changePlaceboDupilumab 300 mg Q2W
Week 1-9.49 ± 2.12-8.66 ± 2.18
Week 2-15.61 ± 3.06-17.41 ± 3.15
Week 3-20.44 ± 3.66-25.26 ± 3.77
Week 4-22.61 ± 4.00-30.09 ± 4.12
Week 5-25.21 ± 4.21-34.41 ± 4.33
Week 6-27.87 ± 4.33-36.98 ± 4.46
Week 7-28.99 ± 4.69-39.30 ± 4.84
Week 8-30.45 ± 4.56-41.32 ± 4.70
Week 9-34.86 ± 4.89-47.08 ± 5.04
Week 10-32.90 ± 5.04-44.65 ± 5.20
Week 11-34.64 ± 5.25-45.98 ± 5.41
Week 12-35.83 ± 5.42-48.86 ± 5.59
Week 13-34.49 ± 5.69-48.32 ± 5.86
Week 14-36.60 ± 5.71-50.67 ± 5.88
Week 15-35.96 ± 5.74-51.89 ± 5.91
Week 16-37.80 ± 5.74-54.36 ± 5.91
Week 17-39.15 ± 5.98-55.95 ± 6.15
Week 18-40.38 ± 6.15-56.80 ± 6.32
Week 19-40.03 ± 6.05-57.75 ± 6.23
Week 20-36.12 ± 5.94-56.80 ± 6.10
Week 21-36.43 ± 6.16-56.91 ± 6.34
Week 22-37.34 ± 6.19-58.78 ± 6.33
Week 23-36.87 ± 6.19-59.43 ± 6.32
Week 24-36.18 ± 6.21-59.34 ± 6.39
SecondaryPercentage of Participants With Improvement (Reduction) in WI-NRS >=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 scale by \>=4 Points at Week 4 is reported in this outcome measure.

Time frame:
Baseline, Week 4
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement (Reduction) in WI-NRS >=4 Points From Baseline at Week 4
percentage of participantsPlaceboDupilumab 300 mg Q2W
Percentage of Participants With Improvement (Reduction) in WI-NRS >=4 Points From Baseline at Week 47.316.7
SecondaryPercentage 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
Reported as:
Number · 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
percentage of participantsPlaceboDupilumab 300 mg Q2W
Week 11.21.3
Week 21.25.1
Week 36.112.8
Week 47.316.7
Week 54.917.9
Week 613.423.1
Week 715.924.4
Week 814.628.2
Week 924.432.1
Week 1018.332.1
Week 1117.133.3
Week 1222.037.2
Week 1319.539.7
Week 1422.039.7
Week 1520.744.9
Week 1619.544.9
Week 1723.247.4
Week 1824.448.7
Week 1923.251.3
Week 2020.751.3
Week 2120.748.7
Week 2222.050.0
Week 2320.755.1
Week 2419.557.7
SecondaryOnset of Action Based on Change From Baseline in WI-NRS at Week 4

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.

Time frame:
Baseline, Week 4
Reported as:
Least squares mean · score on a scale
Onset of Action Based on Change From Baseline in WI-NRS at Week 4
score on a scalePlaceboDupilumab 300 mg Q2W
Onset of Action Based on Change From Baseline in WI-NRS at Week 4-1.94 ± 0.33-2.55 ± 0.34
Statistical analysis
  • Placebo vs Dupilumab 300 mg Q2W · ANCOVA · p = 0.0370 (Threshold of significance was \<0.05.) · Ls mean difference: -0.61 · 95% CI -1.18 to -0.04Dupilumab 300 mg q2w versus Placebo
SecondaryPercentage of Participants With Investigator's Global Assessment for PN-Stage (IGA PN-S) Score of 0 or 1 at Weeks 4 and 8

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.

Time frame:
At Weeks 4 and 8
Reported as:
Number · 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
percentage of participantsPlaceboDupilumab 300 mg Q2W
Week 46.17.7
Week 89.815.4
SecondaryChange 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 prurigo nodularis. LS means and SE were obtained from ANCOVA model.

Time frame:
Baseline, Weeks 4, 8, 12, and 24
Reported as:
Least squares mean · score on a scale
Change From Baseline in IGA PN-S Scores at Weeks 4, 8, 12, and 24
score on a scalePlaceboDupilumab 300 mg Q2W
Week 4-0.54 ± 0.13-0.69 ± 0.13
Week 8-0.79 ± 0.17-1.19 ± 0.17
Week 12-0.86 ± 0.18-1.47 ± 0.18
Week 24-1.07 ± 0.20-2.03 ± 0.20
SecondaryPercentage 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

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.

Time frame:
At Weeks 4, 8, 12 and 24
Reported as:
Number · 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
percentage of participantsPlaceboDupilumab 300 mg Q2W
Week 44.914.1
Week 815.923.1
Week 1219.542.3
Week 2418.351.3
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline in HRQoL, as Measured by DLQI at Week 12
score on a scalePlaceboDupilumab 300 mg Q2W
Change From Baseline in HRQoL, as Measured by DLQI at Week 12-7.05 ± 1.12-12.07 ± 1.16
SecondaryNumber 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 (time 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)
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
ParticipantsPlaceboDupilumab 300 mg Q2W
TEAEs4747
TESAEs42
SecondaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent and Treatment Boosted Antidrug Antibodies (ADA)
ParticipantsPlaceboDupilumab 300 mg Q2W
Treatment-emergent ADAs17
Treatment-boosted ADAs00

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/82 (0%)4/82 (4.9%)10/82 (12.2%)
Dupilumab 300 mg Q2W0/77 (0%)2/77 (2.6%)11/77 (14.3%)
Most frequent serious events
Most frequent serious events
EventPlaceboDupilumab 300 mg Q2W
Pelvic Inflammatory DiseaseInfections and infestations0/821/77
Pyelonephritis AcuteInfections and infestations0/821/77
LipomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/821/77
Uterine LeiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/821/77
Cutaneous T-Cell LymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/820/77
Large Granular LymphocytosisNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/820/77
Cauda Equina SyndromeNervous system disorders1/820/77
Cholecystitis AcuteHepatobiliary disorders1/820/77
Rotator Cuff SyndromeMusculoskeletal and connective tissue disorders1/820/77
Most frequent other events
Most frequent other events
EventPlaceboDupilumab 300 mg Q2W
HeadacheNervous system disorders5/824/77
Accidental OverdoseInjury, poisoning and procedural complications5/824/77
NasopharyngitisInfections and infestations0/824/77

Baseline characteristics

Analysis was performed on randomized population.

Age, Continuous
Age, Continuous(years)PlaceboDupilumab 300 mg Q2WTotal
Mean46.7 ± 15.251.0 ± 15.848.8 ± 15.6
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboDupilumab 300 mg Q2WTotal
Female5152103
Male312657
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboDupilumab 300 mg Q2WTotal
American Indian or Alaska Native101
Asian272552
Native Hawaiian or Other Pacific Islander011
Black or African American538
White484896
More than one race011
Unknown or Not Reported101
08

Study locations

57 sites
  • Investigational Site Number :8400054
    Fort Smith, Arkansas 72916, United States
  • Investigational Site Number :8400008
    Sacramento, California 95816, United States
  • Investigational Site Number :8400005
    Pembroke Pines, Florida 33028, United States
  • Investigational Site Number :8400002
    Plainfield, Indiana 46168, United States
  • Investigational Site Number :8400003
    Baltimore, Maryland 21205, United States
  • Investigational Site Number :8400006
    East Windsor, New Jersey 08520, United States
  • Investigational Site Number :8400001
    Sugar Land, Texas 77479, United States
  • Investigational Site Number :1240002
    Calgary, Alberta T2G 1B1, Canada
  • Investigational Site Number :1240006
    Surrey, British Columbia V3R 6A7, Canada
  • Investigational Site Number :1240007
    Markham, Ontario L3P 1X3, Canada
  • Investigational Site Number :1240008
    Newmarket, Ontario L3Y 5G8, Canada
  • Investigational Site Number :1240001
    Toronto, Ontario M5A 3R6, Canada
  • Investigational Site Number :1240009
    Saskatoon, Saskatchewan S7K 0H6, Canada
  • Investigational Site Number :1520005
    Valdivia, Los Ríos Region 5110683, Chile
  • Investigational Site Number :1520006
    Osorno, Reg Metropolitana de Santiago 5311523, Chile
  • Investigational Site Number :1520003
    Santiago, Reg Metropolitana de Santiago 7580206, Chile
  • Investigational Site Number :1520001
    Santiago, Reg Metropolitana de Santiago 7640881, Chile
  • Investigational Site Number :1520004
    Santiago, Reg Metropolitana de Santiago 80004005, Chile
  • Investigational Site Number :1520002
    Santiago, Chile
  • Investigational Site Number :2500007
    Bordeaux, 33075, France
  • Investigational Site Number :2500001
    Brest, 29200, France
  • Investigational Site Number :2500008
    Le Mans, 72037, France
  • Investigational Site Number :2500002
    Lille, 59037, France
  • Investigational Site Number :2500006
    Lyon, 69003, France
  • Investigational Site Number :2500004
    Paris, 75010, France
  • Investigational Site Number :2500005
    Reims, 51100, France
  • Investigational Site Number :2500003
    Toulouse, 31059, France
  • Investigational Site Number :3480004
    Debrecen, 4032, Hungary
  • Investigational Site Number :3480002
    Orosháza, 5900, Hungary
  • Investigational Site Number :3480005
    Pécs, 7632, Hungary
  • Investigational Site Number :3480003
    Szeged, 6720, Hungary
  • Investigational Site Number :3800001
    Rozzano, Milano 20089, Italy
  • Investigational Site Number :3800004
    Ancona, 60032, Italy
  • Investigational Site Number :3800003
    Catanzaro, 88100, Italy
  • Investigational Site Number :3800002
    Milan, 20122, Italy
  • Investigational Site Number :6200001
    Coimbra, 3000-075, Portugal
  • Investigational Site Number :6200002
    Lisbon, 1998-018, Portugal
  • Investigational Site Number :6200003
    Porto, 4099-001, Portugal
  • Investigational Site Number :4100002
    Busan, Busan 49241, South Korea
  • Investigational Site Number :4100003
    Bucheon-si, Gyeonggi-do 14584, South Korea
  • Investigational Site Number :4100007
    Incheon, Incheon-gwangyeoksi 21431, South Korea
  • Investigational Site Number :4100005
    Seoul, Seoul-teukbyeolsi 03722, South Korea
  • Investigational Site Number :4100001
    Seoul, Seoul-teukbyeolsi 06973, South Korea
  • Investigational Site Number :4100006
    Seoul, Seoul-teukbyeolsi 07441, South Korea
  • Investigational Site Number :7240009
    Badalona, Barcelona [Barcelona] 08916, Spain
  • Investigational Site Number :7240001
    Pontevedra, Galicia [Galicia] 36071, Spain
  • Investigational Site Number :7240008
    Santullano, Principality of Asturias 33619, Spain
  • Investigational Site Number :7240004
    Córdoba, 14004, Spain
  • Investigational Site Number :7240007
    Madrid, 28034, Spain
  • Investigational Site Number :7240003
    Valencia, 46026, Spain
  • Investigational Site Number :7240002
    Zaragoza, 50009, Spain
  • Investigational Site Number :1580005
    Hsinchu, 30059, Taiwan
  • Investigational Site Number :1580006
    Kaohsiung City, 833, Taiwan
  • Investigational Site Number :1580008
    Taichung, Taiwan
  • Investigational Site Number :1580001
    Taipei, 10002, Taiwan
  • Investigational Site Number :1580002
    Taipei, 10449, Taiwan
  • Investigational Site Number :8260001
    Redhill, Surrey RH1 5RH, United Kingdom
09

References and documents

Publications

  • Stander S, Yosipovitch G, Kwatra SG, Mendes-Bastos P, Tsai TF, Nakajima S, Praestgaard AH, Zahn J, Wiggins S. Dupilumab Treatment Provides Multidimensional Benefits in Patients with Prurigo Nodularis. Dermatol Ther (Heidelb). 2026 Jun;16(6):3189-3200. doi: 10.1007/s13555-026-01777-z. Epub 2026 May 13. PubMed 42120670 ↗
  • Stander S, Zeidler C, Msihid J, Makhija M, Bansal A, Wiggins S, Zahn J, Thomas RB, Bahloul D. Dupilumab Improves Prurigo Activity and Severity in Patients with Prurigo Nodularis: A Post Hoc Analysis of Pooled Results from the PRIME and PRIME2 Trials. Dermatol Ther (Heidelb). 2026 Jun;16(6):2829-2835. doi: 10.1007/s13555-026-01692-3. Epub 2026 Apr 1. PubMed 41922877 ↗
  • Yosipovitch G, Kim BS, Koo JY, Chen Z, Wiggins S, Zahn J, Sugerman P, Haddad EB, Cyr SL. Dupilumab Reduces Pruritus in Clinically Distinct Dermatologic Diseases: Data from Clinical Trials on Atopic Dermatitis, Prurigo Nodularis, and Chronic Spontaneous Urticaria. Dermatol Ther (Heidelb). 2026 Apr;16(4):1983-1995. doi: 10.1007/s13555-025-01596-8. Epub 2025 Nov 22. PubMed 41272364 ↗
  • Kim BS, Goncalo M, Ugajin T, Gao XH, Praestgaard AH, Makhija M, Zahn J, Bansal A, Wiggins S. Efficacy and Safety of Dupilumab in Adults with Prurigo Nodularis with or Without Atopic Comorbidities: A Subgroup Analysis from Two Randomized Phase III Clinical Trials. Am J Clin Dermatol. 2026 Jan;27(1):167-180. doi: 10.1007/s40257-025-00993-1. Epub 2025 Nov 11. PubMed 41219577 ↗
  • Kwatra SG, Yosipovitch G, Kim B, Stander S, Rhoten S, Ivanescu C, Haeusler N, Brookes E, Msihid J, Makhija M, Bansal A, Thomas RB, Bahloul D. Worst Itch Numeric Rating Scale for Prurigo Nodularis: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Dermatol. 2024 Aug 1;160(8):813-821. doi: 10.1001/jamadermatol.2024.1634. PubMed 38865146 ↗
  • Yosipovitch G, Mollanazar N, Stander S, Kwatra SG, Kim BS, Laws E, Mannent LP, Amin N, Akinlade B, Staudinger HW, Patel N, Yancopoulos GD, Weinreich DM, Wang S, Shi G, Bansal A, O'Malley JT. Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials. Nat Med. 2023 May;29(5):1180-1190. doi: 10.1038/s41591-023-02320-9. Epub 2023 May 4. PubMed 37142763 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

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

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Aug 2021, 19 months.

Results were first posted in Sep 2022, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2019
First posted
Dec 17, 2019
StartActual
Jan 16, 2020
Primary completionActual
Aug 30, 2021
CompletionActual
Nov 22, 2021
Results first posted
Sep 28, 2022
Last update
Sep 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04202679
Lead sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Dec 17, 2019
Start date
Jan 16, 2020
Primary completion
Aug 30, 2021
Completion
Nov 22, 2021
Results posted
Sep 28, 2022
Last update
Sep 17, 2025

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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