6/28/23, 11:00 PM LIBERTY-PN PRIME2 Pathway Feedback Search Clinical Topics Home Studies LIBERTY PN PRIME2 LIBERTY PN PRIME2 Disease Pruritus Trial question What is the role of dupilumab in patients with prurigo nodularis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 64.0% female N = 160 36.0% male 160 patients (103 female, 57 male) Inclusion criteria: adults with prurigo nodularis with 20 nodules and severe itch uncontrolled with topical therapies Key exclusion criteria: prurigo nodularis secondary to medications or medical conditions; severe renal conditions; uncontrolled thyroid disease; active tuberculosis or NTM infection Interventions N=78 dupilumab (at a dose of 300 mg SC every 2 weeks for 24 weeks) N=82 placebo (matching placebo SC every 2 weeks for 24 weeks) Primary outcome Reduction in Worst Itch Numeric Rating Scale by 4-point at week 12 https://web.pathway.md/studies/reclQ2aJFyTKkjphZ 1/2 6/28/23, 11:00 PM LIBERTY-PN PRIME2 Pathway 37.2 % 37.2 27.9 % 22 18.6 % Significant increase 9.3 % NNT = 7 0.0 % Dupilumab Placebo Significant increase in reduction in Worst Itch NRS by 4-point at week 12 (37.2% vs. 22%; AD 16.8%, 95% CI 2.3 to 31.2) Secondary outcomes Significant increase in Investigator's Global Assessment for Prurigo Nodularis-Stage score of 0 or 1 at week 24 (44.9% vs. 15.9%; AD 30.8%, 95% CI 16.4 to 45.2) Significant increase in reduction in Worst Itch NRS by 4-point at week 24 (57.7% vs. 19.5%; AD 42.6%, 95% CI 29.1 to 56.1) Significant increase in concomitant reduction in Worst Itch NRS by 4 points and Investigator's Global Assessment for Prurigo Nodularis-Stage score of 0 or 1 at week 24 (32.1% vs. 8.5%; AD 25.5%, 95% CI 13.1 to 37.9) Safety outcomes No significant difference in treatment-emergent serious adverse events. Conclusion In adults with prurigo nodularis with 20 nodules and severe itch uncontrolled with topical therapies, dupilumab was superior to placebo with respect to reduction in Worst Itch NRS by 4- point at week 12. Reference Gil Yosipovitch, Nicholas Mollanazar, Sonja St nder et al. Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials. Nat Med. 2023 May;29(5):1180-1190. Open reference URL https://web.pathway.md/studies/reclQ2aJFyTKkjphZ 2/2