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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)

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ClinicalTrials.gov Identifier: NCT04202679
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : September 14, 2020
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate the efficacy of dupilumab on itch response in patients 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 patients 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


Condition or disease Intervention/treatment Phase
Neurodermatitis Drug: Dupilumab SAR231893 Drug: Placebo Drug: Moisturizers Drug: Low to medium potent topical corticosteroids Drug: Topical calcineurin inhibitors Phase 3

Detailed Description:
The duration of study for each participant will include 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 16, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Dupilumab
Dose regimen 1 on top of moisturizers and if applicable low to medium potent topical corticosteroids or topical calcineurin inhibitors
Drug: Dupilumab SAR231893
Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Drug: Moisturizers

Pharmaceutical form:

Route of administration: Topical


Drug: Low to medium potent topical corticosteroids

Pharmaceutical form:

Route of administration: Topical


Drug: Topical calcineurin inhibitors

Pharmaceutical form:

Route of administration: Topical


Placebo Comparator: Matched placebo
Placebo on top of moisturizers and if applicable low to medium potent topical corticosteroids or topical calcineurin inhibitors
Drug: Placebo
Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Drug: Moisturizers

Pharmaceutical form:

Route of administration: Topical


Drug: Low to medium potent topical corticosteroids

Pharmaceutical form:

Route of administration: Topical


Drug: Topical calcineurin inhibitors

Pharmaceutical form:

Route of administration: Topical





Primary Outcome Measures :
  1. Improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 [ Time Frame: Baseline to Week 12 ]
    Proportion of participants with improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 from baseline to Week 12


Secondary Outcome Measures :
  1. Improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 [ Time Frame: Baseline to Week 24 ]
    Proportion of participants with improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 from baseline to Week 24.

  2. Proportion of participants with Investigator's Global Assessment 0 or 1 score for PN-stage at Week 24 [ Time Frame: Baseline to Week 24 ]
    Proportion of participants with Investigator's Global Assessment 0 or 1 score for PN-Stage (IGA PN-S) at Week 24.

  3. Time to onset of effect on pruritus [ Time Frame: Baseline to overtime until Week 24 ]
    Time to onset of effect on pruritus as measured by proportion of participants with an improvement (reduction) in WI-NRS by ≥4 from baseline during the 24-week treatment period.

  4. Change from baseline in WI-NRS [ Time Frame: Baseline to Week 12 and Week 24 ]
    Change from baseline in WI-NRS at Week 12 and Week 24

  5. Percent change from baseline in WI-NRS [ Time Frame: Baseline to Week 2, Week 4, Week 12 and Week 24 ]
    Percent change from baseline in WI-NRS at Week 2, Week 4, Week 12 and Week 24.

  6. Percent change from baseline in WI-NRS over time [ Time Frame: Baseline to overtime until Week 24 ]
    Percent change from baseline in WI-NRS over time until Week 24.

  7. Proportion of participants with WI-NRS reduction ≥4 at Week 4 [ Time Frame: Baseline to Week 4 ]
    Proportion of participants with WI-NRS reduction ≥4 at Week 4

  8. Proportion of participants with WI-NRS reduction ≥4 over time [ Time Frame: Baseline to overtime until Week 24 ]
    Proportion of participants with WI-NRS reduction ≥4 over time until Week 24.

  9. Onset of action in change from baseline in WI-NRS [ Time Frame: Baseline to overtime until Week 12 ]
    Onset of action in change from baseline in WI-NRS (first p<0.05 difference from placebo in the daily WI-NRS that remains significant at subsequent measurements) until Week 12.

  10. Proportion of participants with Investigator's Global Assessment 0 or 1 score for PN-stage [ Time Frame: Baseline to Week 4, Week 8 and Week 12 ]
    Proportion of participants with Investigator's Global Assessment 0 or 1 score for PN-Stage (IGA PN-S) at Week 4, Week 8 and Week 12.

  11. Change from baseline in IGA PN-S score [ Time Frame: Baseline to Week 4, Week 8, Week 12, and Week 24 ]
    Change from baseline in IGA PN-S score at Week 4, Week 8, Week 12 and Week 24.

  12. Proportion of participants with Investigator's Global Assessment 0 or 1 score for PN-Activity [ Time Frame: Baseline to Week 4, Week 8, Week 12, and Week 24 ]
    Proportion of participants with Investigator's Global Assessment 0 or 1 score for PN-Activity (IGA PN-A) at Week 4, Week 8, Week 12, and Week 24.

  13. Change from baseline in health-related quality-of-life [ Time Frame: Baseline to Week 12 and Week 24 ]
    Change from baseline in health-related quality-of-life, as measured by Dermatology Life Quality Index (DLQI) to Week 12 and Week 24.

  14. Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through Week 24 [ Time Frame: Baseline to Week 24 ]
    Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through Week 24.

  15. Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab over time [ Time Frame: Baseline to Week 24 ]
    Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab over time.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

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 WI-NRS ranging from 0 to 10, patients must have an average worst itch score of ≥7 in the 7 days prior to Day1.
  • Patients 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

Exclusion criteria:

Participants are 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 AD from screening visit to randomization visit
  • Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the patient's participation in the study
  • Severe renal conditions (eg, patients 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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04202679


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04202679    
Other Study ID Numbers: EFC16460
2019-003801-90
U1111-1241-8174 ( Other Identifier: UTN )
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prurigo
Neurodermatitis
Skin Diseases
Dermatitis
Skin Diseases, Eczematous
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action