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)

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.

Timeline

Start

2020-01-16

Primary completion

2021-08-30

Completion

2021-11-22

Publications

• Stander S, Yosipovitch G, Kwatra SG, Mendes-Bastos P, Tsai TF, Nakajima S, Praestgaard AH, Zahn J, Wiggins S. Dupilumab Treatment Provides Multidimensional Benefits in Patients with Prurigo Nodularis. Dermatol Ther (Heidelb). 2026 Jun;16(6):3189-3200. doi: 10.1007/s13555-026-01777-z. Epub 2026 May 13.
• Stander S, Zeidler C, Msihid J, Makhija M, Bansal A, Wiggins S, Zahn J, Thomas RB, Bahloul D. Dupilumab Improves Prurigo Activity and Severity in Patients with Prurigo Nodularis: A Post Hoc Analysis of Pooled Results from the PRIME and PRIME2 Trials. Dermatol Ther (Heidelb). 2026 Jun;16(6):2829-2835. doi: 10.1007/s13555-026-01692-3. Epub 2026 Apr 1.
• Yosipovitch G, Kim BS, Koo JY, Chen Z, Wiggins S, Zahn J, Sugerman P, Haddad EB, Cyr SL. Dupilumab Reduces Pruritus in Clinically Distinct Dermatologic Diseases: Data from Clinical Trials on Atopic Dermatitis, Prurigo Nodularis, and Chronic Spontaneous Urticaria. Dermatol Ther (Heidelb). 2026 Apr;16(4):1983-1995. doi: 10.1007/s13555-025-01596-8. Epub 2025 Nov 22.
• Kim BS, Goncalo M, Ugajin T, Gao XH, Praestgaard AH, Makhija M, Zahn J, Bansal A, Wiggins S. Efficacy and Safety of Dupilumab in Adults with Prurigo Nodularis with or Without Atopic Comorbidities: A Subgroup Analysis from Two Randomized Phase III Clinical Trials. Am J Clin Dermatol. 2026 Jan;27(1):167-180. doi: 10.1007/s40257-025-00993-1. Epub 2025 Nov 11.
• Kwatra SG, Yosipovitch G, Kim B, Stander S, Rhoten S, Ivanescu C, Haeusler N, Brookes E, Msihid J, Makhija M, Bansal A, Thomas RB, Bahloul D. Worst Itch Numeric Rating Scale for Prurigo Nodularis: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Dermatol. 2024 Aug 1;160(8):813-821. doi: 10.1001/jamadermatol.2024.1634.
• Yosipovitch G, Mollanazar N, Stander S, Kwatra SG, Kim BS, Laws E, Mannent LP, Amin N, Akinlade B, Staudinger HW, Patel N, Yancopoulos GD, Weinreich DM, Wang S, Shi G, Bansal A, O'Malley JT. Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials. Nat Med. 2023 May;29(5):1180-1190. doi: 10.1038/s41591-023-02320-9. Epub 2023 May 4.

Drugs

Indications