AzTrials
AzTrials

NeurodermatitisPhase 3NCT04183335

Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)

A Phase 3 study testing Dupilumab SAR231893, Moisturizers and Low to medium potent topical corticosteroids in people with Neurodermatitis, run by Sanofi at 63 sites in 8 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 therapies 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
151 participants
Where
63 sitesin 8 countries
Study dates
12 Dec 2019to 3 Feb 2022
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) ranged from 0 to 10, participants who had an average worst itch score of greater than or equal to (>=) 7 in the 7 days prior to Day 1.
  • Participants who had 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 TCS or when TCS were not medically advisable.
  • Had 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.
  • Was willing and abled to complete a daily symptom electronic-diary 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 (AD) that interfered 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 AD 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 had ruled out active infection before randomization.
  • Active chronic or acute infection (except human immunodeficiency virus infection) required treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit or 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

63 sites in 8 countries.

63 sites in 8 countries

United States21 sites

  • Investigational Site Number :8400009

    Athens, Ohio, 45701

  • Investigational Site Number :8400006

    Bellaire, Texas, 77401

  • Investigational Site Number :8400015

    Charleston, South Carolina, 29414

  • Investigational Site Number :8400018

    Clarkston, Michigan, 48346

  • Investigational Site Number :8400004

    Columbus, Georgia, 31904

  • Investigational Site Number :8400001

    Dublin, Ohio, 43016

  • Investigational Site Number :8400024

    East Windsor, New Jersey, 08520

  • Investigational Site Number :8400022

    Fort Smith, Arkansas, 72916

  • Investigational Site Number :8400011

    Gilbert, Arizona, 85234

  • Investigational Site Number :8400025

    Houston, Texas, 77058

  • Investigational Site Number :8400016

    Indianapolis, Indiana, 46250

  • Investigational Site Number :8400014

    Miami, Florida, 33136

  • Investigational Site Number :8400003

    Newnan, Georgia, 30263

  • Investigational Site Number :8400005

    Norfolk, Virginia, 23502

  • Investigational Site Number :8400002

    Pflugerville, Texas, 78660

  • Investigational Site Number :8400010

    Philadelphia, Pennsylvania, 19104

  • Investigational Site Number :8400026

    Sacramento, California, 95816

  • Investigational Site Number :8400019

    San Antonio, Texas, 78249

  • Investigational Site Number :8400017

    Sandy Springs, Georgia, 30328

  • Investigational Site Number :8400013

    St Louis, Missouri, 63110

  • Investigational Site Number :8400007

    Tulsa, Oklahoma, 74136

Other trials in United States

Argentina9 sites

  • Investigational Site Number :0320001

    Buenos Aires, C1121ABE

  • Investigational Site Number :0320006

    Caba, 1425DES

  • Investigational Site Number :0320008

    CABA, Buenos Aires, C1023AAB

  • Investigational Site Number :0320005

    CABA, Buenos Aires, C1055AAO

  • Investigational Site Number :0320002

    CABA, Buenos Aires, C1425BEN

  • Investigational Site Number :0320004

    CABA, Buenos Aires F.D., C1425BEA

  • Investigational Site Number :0320007

    CABA, Buenos Aires F.D., C1431EKK

  • Investigational Site Number :0320009

    Mendoza, M5500

  • Investigational Site Number :0320003

    San Miguel de Tucumán, Tucumán Province, T4000AXL

Other trials in Argentina

Japan9 sites

  • Investigational Site Number :3920004

    Bunkyo-ku, Tokyo, 113-8519

  • Investigational Site Number :3920010

    Izumo-shi, Shimane, 693-8501

  • Investigational Site Number :3920005

    Kyoto, Kyoto, 606-8507

  • Investigational Site Number :3920007

    Nagasaki, Nagasaki, 852-8501

  • Investigational Site Number :3920002

    Nagoya, 454-8509

  • Investigational Site Number :3920001

    Shinagawa-Ku, Tokyo, 141-8625

  • Investigational Site Number :3920006

    tabashi City, Tokyo, 173-8610

  • Investigational Site Number :3920003

    Tokorozawa-shi, Saitama, 359-8513

  • Investigational Site Number :3920009

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Russia8 sites

  • Investigational Site Number :6430008

    Chelyabinsk, 454048

  • Investigational Site Number :6430007

    Krasnodar, 350020

  • Investigational Site Number :6430005

    Moscow, 107076

  • Investigational Site Number :6430010

    Moscow, 115522

  • Investigational Site Number :6430006

    Moscow, 125993

  • Investigational Site Number :6430002

    Saint Petersburg, 197022

  • Investigational Site Number :6430009

    Saratov, 410026

  • Investigational Site Number :6430001

    Stavropol, 355030

Other trials in Russia

South Korea6 sites

  • Investigational Site Number :4100005

    Incheon, Incheon-gwangyeoksi, 21431

  • Investigational Site Number :4100001

    Incheon, 21565

  • Investigational Site Number :4100007

    Seongnam-si, Gyeonggi-do, 13620

  • Investigational Site Number :4100002

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number :4100003

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number :4100004

    Seoul, Seoul-teukbyeolsi, 07441

Other trials in South Korea

Mexico5 sites

  • Investigational Site Number :4840002

    Guadalajara, Jalisco, 44100

  • Investigational Site Number :4840006

    Guadalajara, 44210

  • Investigational Site Number :4840001

    Monterrey, Nuevo León, 64460

  • Investigational Site Number :4840005

    Monterrey, Nuevo León, 64718

  • Investigational Site Number :4840003

    Veracruz, 91910

Other trials in Mexico

China4 sites

  • Investigational Site Number :1560004

    Beijing, 100050

  • Investigational Site Number :1560001

    Chengdu, 610041

  • Investigational Site Number :1560002

    Hangzhou, 310006

  • Investigational Site Number :1560003

    Wuxi, 214002

Other trials in China

France1 site

  • Investigational Site Number :2500005

    Reims, 51100

Other trials in France

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 therapies or when those therapies are not advisable.

Secondary Objectives:

To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapies or when those therapies are not advisable.

To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.

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 NCT04183335
Study groupRoleWhat they receive
DupilumabExperimentalParticipants received dupilumab at a loading dose of 600 milligrams (mg), subcutaneously (SC) on Day 1 followed by dupilumab 300 mg once every 2 weeks (q2w) for 24 weeks added to background therapy of topical corticosteroids/topical calcineurin inhibitors (TCS/TCI) at stable dose.
Receives: Drug: Dupilumab SAR231893; Drug: Moisturizers; Drug: Low to medium potent topical corticosteroids; Drug: Topical calcineurin inhibitors
PlaceboPlacebo comparatorParticipants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
Receives: Drug: Placebo; 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 Improvement (Reduction) in Worst Itch Numeric Rating Scale (WI-NRS) Scores by Greater Than or Equal to (>=) 4 Points From Baseline to Week 24

    WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with improvement (reduction) in WI-NRS scores by >=4 points from Baseline to Week 24 is reported in this outcome measure.

    Measured: Baseline, Week 24

Secondary outcomes (20)

  1. Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage (IGA PN-S) Scores of 0 or 1 at Week 24

    IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis (PN). In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.

    Measured: At Week 24

  2. Percentage of Participants With Both an Improvement (Reduction) in WI-NRS Scores by >=4 Points and an IGA PN-S Scores of 0 or 1 From Baseline at Week 24

    WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch), higher scores indicated more severity. IGA PN-S assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicated greater severity. Percentage of participants with both an improvement (reduction) in WI-NRS scores by >=4 points (from Baseline) and an IGA PN-S scores of 0 or 1 were reported in this outcome measure.

    Measured: Baseline, Week 24

  3. Percent Change From Baseline in WI-NRS Scores at Week 24

    WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Least squares (LS) mean and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model.

    Measured: Baseline, Week 24

  4. 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

  5. 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

  6. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 24

    HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale comprised of 7 items with a scoring range from 0 (less severity of anxiety and depression) to 21 (greater severity of anxiety and depression symptoms) for each subscale. The total HADS score ranges from 0 (less severity) to 42 (more severity), with a high score indicative of severe anxiety and/or depression level. LS means and SE were obtained from ANCOVA model.

    Measured: Baseline, Week 24

  7. Probability of Participants With an Improvement (Reduction) in WI-NRS Scores by >=4 Points From Baseline at Week 24

    WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Probability of participants with an improvement (reduction) in WI-NRS at Week 24 was based on Kaplan-Meier estimates and was reported in this outcome measure.

    Measured: Baseline, Week 24

  8. Change From Baseline in WI-NRS Scores at Week 12 and 24

    WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.

    Measured: Baseline, Weeks 12 and 24

  9. 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

  10. Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

    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

  11. Percentage of Participants With Improvement (Reduction) in WI-NRS Scores by >=4 Points From Baseline at Week 12

    WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with improvement (reduction) in WI-NRS score by >=4 points from Baseline to Week 12 is reported in this outcome measure.

    Measured: Baseline, Week 12

  12. Percentage of Participants With Improvement (Reduction) in WI-NRS Scores by >=4 Points From Baseline at Week 4

    WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with improvement (reduction) in WI-NRS scores by >=4 Points at Week 4 is reported in this outcome measure.

    Measured: Baseline, Week 4

  13. 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

  14. Onset of Action Based on Change From Baseline in WI-NRS Scores at Week 3

    Onset of action was defined as the first p<0.05 difference from placebo in the weekly average WI-NRS that remained significant at subsequent measurements. WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated greater severity. LS means and SE were obtained from ANCOVA model.

    Measured: Baseline, Week 3

  15. Percentage of Participants With Investigator's Global Assessment for PN-Stage (IGA PN-S) 0 or 1 Score at Weeks 4, 8, and 12

    IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.

    Measured: At Weeks 4, 8 and 12

  16. Change From Baseline in IGA PN-S Scores at Weeks 4, 8, 12, and 24

    IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN. LS means and SE were obtained from ANCOVA model.

    Measured: Baseline, Weeks 4, 8, 12, and 24

  17. Percentage of Participants With Investigator's Global Assessment for PN-Activity (IGA PN-A) 0 or 1 Score at Weeks 4, 8, 12 and 24

    The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear (0% nodules showing excoriations/crusts), 1 = almost clear (up to 10% nodules showing excoriations/crusts), 2 = mild (11-25% nodules showing excoriations/crusts), 3 = moderate (26-75% nodules showing excoriations/crusts) and 4 = severe (76-100% of nodules showing excoriations/crusts). Higher scores indicate severe PN. In this outcome measure, percentage of participants with IGA PN-A score of either 0 (clear) or 1 (almost clear) has been reported.

    Measured: At Weeks 4, 8, 12 and 24

  18. 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

  19. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the treatment-emergent (TE) period (from the first investigational medicinal product [IMP] administration to the last IMP administration + 14 weeks).

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

  20. 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 posted3 Dec 2019
  2. Study start12 Dec 2019
  3. Primary completion12 Nov 2021
  4. Study completion3 Feb 2022

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
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04183335
Sponsor's protocol ID
EFC16459
Other IDs
2019-003774-41, U1111-1241-8153, 2019
Status last verified
Sep 2025
First submitted
27 Nov 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

  • 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 63 sites in 8 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 63 sites in United States, Argentina, Japan, Russia, South Korea and 3 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 12 Dec 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 Improvement (Reduction) in Worst Itch Numeric Rating Scale (WI-NRS) Scores by Greater Than or Equal to (>=) 4 Points From Baseline to Week 24 (time frame: Baseline, Week 24). 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 NCT04183335, which also lists 5 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.

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