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)
Completed · Phase 3 · NCT04202679
Conditions: Neurodermatitis
At a glance
- Research payments reported, 2025
- $2,000
- U.S. investigators named
- 0
- Sites paid
- 0
- Planned or actual enrollment
- 160
About the trial
- Sponsor
- Sanofi (with Regeneron Pharmaceuticals)
- Tested
- Dupilumab SAR231893 (drug), Placebo (drug), Moisturizers (drug), Low to medium potent topical corticosteroids (drug), Topical calcineurin inhibitors (drug)
- Dates
- Started 2020-01-16; completion 2021-11-22
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2025-09-17. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Genzyme Corporation reported $2,000 in research payments for this study in 2025 (4 payments).
Products named: Dupixent
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
Sites paid to run it
- $2,000
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.