NCT04202679

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)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-16
• Primary completion: 2021-08-30
• Completion: 2021-11-22
• First posted: 2019-12-17
• Last updated: 2025-09-17
• Results posted: 2022-09-28

Locations

57 sites across 11 countries: United States, Canada, Chile, France, Hungary, Italy, Portugal, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study