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)

Conditions

• Neurodermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Dupilumab SAR231893 — DRUG
  Pharmaceutical form:Injection solution Route of administration: Subcutaneous
• Placebo — DRUG
  Pharmaceutical form:Injection solution Route of administration: Subcutaneous
• Moisturizers — DRUG
  Pharmaceutical form: Route of administration: Topical
• Low to medium potent topical corticosteroids — DRUG
  Pharmaceutical form: Route of administration: Topical
• Topical calcineurin inhibitors — DRUG
  Pharmaceutical form: Route of administration: Topical

Study Details

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.

Key Dates

Start date

Jan 16, 2020

Status verified

Sep 2025

Primary completion

Aug 30, 2021

Completion

Nov 22, 2021

Study Design

Enrollment

160 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.
• 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.

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 ]

Locations (7)

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