Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)
Summary
Primary Objective: This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders) Secondary Objectives: This study aimed to demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints This study aimed to demonstrate the efficacy of dupilumab on angioedema This study aimed to demonstrate the efficacy of dupilumab on urticaria control This study aimed to demonstrate improvement in health-related quality of life and overall disease status and severity This study aimed to evaluate the ability of dupilumab in reducing the proportion of participants who require treatment with oral corticosteroids (OCS) This study aimed to evaluate safety outcome measures This study aimed to evaluate immunogenicity of dupilumab
Timeline
- Start
- 2019-12-11
- Primary completion
- 2024-08-01
- Completion
- 2024-10-25
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry Study A: Placebo vs Study A: Dupilumab; p = 0.0005; LS Mean Difference -4.23 (95% CI -6.63 to -1.84) reads as mixed primary results NCT04180488 ↗
registry Study B: Placebo vs Study B: Dupilumab; p = 0.0449; LS Mean Difference -2.87 reads as mixed primary results NCT04180488 ↗
registry note: Threshold for significance at 2-sided 0.043 level. reads as mixed primary results NCT04180488 ↗
registry Study C: Placebo vs Study C: Dupilumab; p = 0.0184; LS Mean Difference -2.54 (95% CI -4.65 to -0.43) reads as mixed primary results NCT04180488 ↗
release “A pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU) met its primary and all key secondary endpoints” reads as met primary endpoint regeneron.com ↗
release “Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naïve patients, compared to those treated with antihistamines alone (placebo) in Study A” reads as met primary endpoint sanofi.com ↗
release “a Phase 3 trial in patients with moderate-to-severe chronic spontaneous urticaria (CSU) met its primary and all key secondary endpoints at 24 weeks.” reads as met primary endpoint regeneron.com ↗
release “Dupixent ® met its primary and all key secondary endpoints in Study A (the first of two trials) of the pivotal LIBERTY CUPID clinical program” reads as met primary endpoint sanofi.com ↗
release “CUPID STUDY B) evaluating Dupixent ® (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility” reads as missed primary endpoint sanofi.com ↗
release “results from the interim analysis did not demonstrate statistical significance for the primary endpoints.” reads as missed primary endpoint sanofi.com ↗
release “The CUPID Study B evaluating Dupixent ® in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, stopped due to futility” reads as missed primary endpoint sanofi.com ↗
release “NCT04180488; Study A and Study C ), both of which demonstrated Dupixent significantly reduced itch and hives” reads as met primary endpoint sanofi.com ↗
Publications
- Casale TB, Saini SS, Ben-Shoshan M, Gimenez-Arnau AM, Bernstein JA, Hayama K, Amin N, Robinson LB, Bauer D, Dakin P, Laws E, Radin A, Makhija M. Dupilumab in Patients With Chronic Spontaneous Urticaria: Phase 3 LIBERTY-CSU CUPID Randomized Clinical Trials. JAMA Dermatol. 2026 Apr 1;162(4):350-358. doi: 10.1001/jamadermatol.2025.6023.
- Gimenez-Arnau AM, Casale TB, Yosipovitch G, Ensina LF, Inomata N, Msihid J, Makhija M, Radin A, Cyr SL, Sugerman P, Thomas RB, Chuang CC. Dupilumab Improves Health-Related Quality of Life in Omalizumab-Naive Patients with Chronic Spontaneous Urticaria. Dermatol Ther (Heidelb). 2026 Jan;16(1):549-562. doi: 10.1007/s13555-025-01605-w. Epub 2025 Dec 2.
- 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.
- Maurer M, Casale TB, Saini SS, Ben-Shoshan M, Laws E, Maloney J, Bauer D, Radin A, Makhija M. Dupilumab Reduces Urticaria Activity, Itch, and Hives in Patients with Chronic Spontaneous Urticaria Regardless of Baseline Serum Immunoglobulin E Levels. Dermatol Ther (Heidelb). 2024 Sep;14(9):2427-2441. doi: 10.1007/s13555-024-01231-y. Epub 2024 Jul 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | 200 mg | Subcutaneous |
| Subject | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |