AzTrials
AzTrials

NeurodermatitisPhase 3NCT04202679

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 study testing Dupilumab SAR231893, Moisturizers and Low to medium potent topical corticosteroids in people with Neurodermatitis, run by Sanofi at 57 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Neurodermatitis
What is being tested?
Dupilumab SAR231893, Moisturizers and Low to medium potent topical corticosteroids
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
57 sitesin 11 countries
Study dates
16 Jan 2020to 22 Nov 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be 18 to 80 years of age, at the time of signing the informed consent.
  • 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 corticosteroids (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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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 HIV) 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 malignancy 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-metastatic 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.

Trial locations and contacts

57 sites in 11 countries.

57 sites in 11 countries

France8 sites

  • Investigational Site Number :2500007

    Bordeaux, 33075

  • Investigational Site Number :2500001

    Brest, 29200

  • Investigational Site Number :2500008

    Le Mans, 72037

  • Investigational Site Number :2500002

    Lille, 59037

  • Investigational Site Number :2500006

    Lyon, 69003

  • Investigational Site Number :2500004

    Paris, 75010

  • Investigational Site Number :2500005

    Reims, 51100

  • Investigational Site Number :2500003

    Toulouse, 31059

Other trials in France

United States7 sites

  • Investigational Site Number :8400003

    Baltimore, Maryland, 21205

  • Investigational Site Number :8400006

    East Windsor, New Jersey, 08520

  • Investigational Site Number :8400054

    Fort Smith, Arkansas, 72916

  • Investigational Site Number :8400005

    Pembroke Pines, Florida, 33028

  • Investigational Site Number :8400002

    Plainfield, Indiana, 46168

  • Investigational Site Number :8400008

    Sacramento, California, 95816

  • Investigational Site Number :8400001

    Sugar Land, Texas, 77479

Other trials in United States

Spain7 sites

  • Investigational Site Number :7240009

    Badalona, Barcelona [Barcelona], 08916

  • Investigational Site Number :7240004

    Córdoba, 14004

  • Investigational Site Number :7240007

    Madrid, 28034

  • Investigational Site Number :7240001

    Pontevedra, Galicia [Galicia], 36071

  • Investigational Site Number :7240008

    Santullano, Principality of Asturias, 33619

  • Investigational Site Number :7240003

    Valencia, 46026

  • Investigational Site Number :7240002

    Zaragoza, 50009

Other trials in Spain

Canada6 sites

  • Investigational Site Number :1240002

    Calgary, Alberta, T2G 1B1

  • Investigational Site Number :1240007

    Markham, Ontario, L3P 1X3

  • Investigational Site Number :1240008

    Newmarket, Ontario, L3Y 5G8

  • Investigational Site Number :1240009

    Saskatoon, Saskatchewan, S7K 0H6

  • Investigational Site Number :1240006

    Surrey, British Columbia, V3R 6A7

  • Investigational Site Number :1240001

    Toronto, Ontario, M5A 3R6

Other trials in Canada

Chile6 sites

  • Investigational Site Number :1520006

    Osorno, Reg Metropolitana de Santiago, 5311523

  • Investigational Site Number :1520003

    Santiago, Reg Metropolitana de Santiago, 7580206

  • Investigational Site Number :1520001

    Santiago, Reg Metropolitana de Santiago, 7640881

  • Investigational Site Number :1520004

    Santiago, Reg Metropolitana de Santiago, 80004005

  • Investigational Site Number :1520002

    Santiago

  • Investigational Site Number :1520005

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

South Korea6 sites

  • Investigational Site Number :4100003

    Bucheon-si, Gyeonggi-do, 14584

  • Investigational Site Number :4100002

    Busan, Busan, 49241

  • Investigational Site Number :4100007

    Incheon, Incheon-gwangyeoksi, 21431

  • Investigational Site Number :4100005

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number :4100001

    Seoul, Seoul-teukbyeolsi, 06973

  • Investigational Site Number :4100006

    Seoul, Seoul-teukbyeolsi, 07441

Other trials in South Korea

Taiwan5 sites

  • Investigational Site Number :1580005

    Hsinchu, 30059

  • Investigational Site Number :1580006

    Kaohsiung City, 833

  • Investigational Site Number :1580008

    Taichung

  • Investigational Site Number :1580001

    Taipei, 10002

  • Investigational Site Number :1580002

    Taipei, 10449

Other trials in Taiwan

Hungary4 sites

  • Investigational Site Number :3480004

    Debrecen, 4032

  • Investigational Site Number :3480002

    Orosháza, 5900

  • Investigational Site Number :3480005

    Pécs, 7632

  • Investigational Site Number :3480003

    Szeged, 6720

Other trials in Hungary

Italy4 sites

  • Investigational Site Number :3800004

    Ancona, 60032

  • Investigational Site Number :3800003

    Catanzaro, 88100

  • Investigational Site Number :3800002

    Milan, 20122

  • Investigational Site Number :3800001

    Rozzano, Milano, 20089

Other trials in Italy

Portugal3 sites

  • Investigational Site Number :6200001

    Coimbra, 3000-075

  • Investigational Site Number :6200002

    Lisbon, 1998-018

  • Investigational Site Number :6200003

    Porto, 4099-001

Other trials in Portugal

United Kingdom1 site

  • Investigational Site Number :8260001

    Redhill, Surrey, RH1 5RH

Other trials in United Kingdom

About this study

Official title: A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable

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.

Conditions
Neurodermatitis
Being tested
Dupilumab SAR231893, Placebo, Moisturizers, Low to medium potent topical corticosteroids, Topical calcineurin inhibitors
Medical subject headings
Neurodermatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dupilumab SAR231893Drug

    Pharmaceutical form:Injection solution Route of administration: Subcutaneous

  • PlaceboDrug

    Pharmaceutical form:Injection solution Route of administration: Subcutaneous

  • MoisturizersDrug

    Pharmaceutical form:

    Route of administration: Topical

  • Low to medium potent topical corticosteroidsDrug

    Pharmaceutical form:

    Route of administration: Topical

  • Topical calcineurin inhibitorsDrug

    Pharmaceutical form:

    Route of administration: Topical

Study groups in NCT04202679
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo; Drug: Moisturizers; Drug: Low to medium potent topical corticosteroids; Drug: Topical calcineurin inhibitors
Dupilumab 300 mg Q2WExperimentalParticipants 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.
Receives: Drug: Dupilumab SAR231893; Drug: Moisturizers; Drug: Low to medium potent topical corticosteroids; Drug: Topical calcineurin inhibitors

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 12

Secondary outcomes (22)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2019
  2. Study start16 Jan 2020
  3. Primary completion30 Aug 2021
  4. Study completion22 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04202679
Sponsor's protocol ID
EFC16460
Other IDs
2019-003801-90, U1111-1241-8174, 2019
Status last verified
Sep 2025
First submitted
16 Dec 2019
Last updated
17 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab SAR231893, Moisturizers and Low to medium potent topical corticosteroids in people with Neurodermatitis, run by Sanofi at 57 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in France, United States, Spain, Canada, Chile and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04202679, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in