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)
Condition: Neurodermatitis
MeSH terms: Prurigo; Neurodermatitis
Intervention: Dupilumab SAR231893; Placebo; Moisturizers; Low to medium potent topical corticosteroids; Topical calcineurin inhibitors
Intervention description: Pharmaceutical form:Injection solution Route of administration: Subcutaneous; Pharmaceutical form:Injection solution Route of administration: Subcutaneous; Pharmaceutical form:
Route of administration: Topical; Pharmaceutical form:
Route of administration: Topical; Pharmaceutical form:
Route of administration: Topical
Intervention MeSH terms: Calcineurin Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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.
    

Eligibility 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 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.

        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 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.