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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)

NCT04202679 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-09-17

Study results available
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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.

Conditions

  • Neurodermatitis

Interventions

DRUG

Dupilumab SAR231893

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2021-08-30
Completion
2021-11-22
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Chile
  • France
  • Hungary
  • Italy
  • Portugal
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04202679 on ClinicalTrials.gov