Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
Summary
The main purpose of the study was to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.
Timeline
- Start
- 2019-06-27
- Primary completion
- 2021-12-29
- Completion
- 2022-08-11
Outcome
Met primary endpoint
paper Both trials met the coprimary endpoints; PMID 39067461 ↗
registry p = 0.0003; Strata-adjusted percentage difference 11.5 (97.5% CI 4.7 to 18.3) NCT03985943 ↗
registry p = 0.0002; Strata-adjusted percentage difference 14.3 (97.5% CI 6.1 to 22.5) NCT03985943 ↗
registry p <0.0001; Strata-adjusted percentage difference 14.9 (97.5% CI 7.8 to 22.0) NCT03985943 ↗
registry p <0.0001; Strata-adjusted percentage difference 18.1 (97.5% CI 9.6 to 26.6) NCT03985943 ↗
Publications
- Silverberg JI, Filipenko D, Dias Barbosa C, Rodriguez D, Chambenoit O, Jack K, Piketty C, Subramanian R, Puelles J. Patients' Experiences of Atopic Dermatitis and Nemolizumab Treatment: An In-Trial Interview Study Embedded in a Phase 3 Clinical Trial (ARCADIA). Patient. 2025 Sep;18(5):511-521. doi: 10.1007/s40271-025-00741-x. Epub 2025 May 13.
- Silverberg JI, Rodriguez DN, Dias-Barbosa C, Filipenko D, Ulianov L, Piketty C, Puelles J. Psychometric Validation of the Subject Sleep Diary in Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Apr;15(4):963-995. doi: 10.1007/s13555-025-01385-3. Epub 2025 Mar 21.
- Silverberg JI, Wollenberg A, Reich A, Thaci D, Legat FJ, Papp KA, Stein Gold L, Bouaziz JD, Pink AE, Carrascosa JM, Rewerska B, Szepietowski JC, Krasowska D, Havlickova B, Kalowska M, Magnolo N, Pauser S, Nami N, Sauder MB, Jain V, Padlewska K, Cheong SY, Fleuranceau Morel P, Ulianov L, Piketty C; ARCADIA 1 and ARCADIA 2 Study Investigators. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials. Lancet. 2024 Aug 3;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0. Epub 2024 Jul 24.
- Dias-Barbosa C, Silverberg JI, Stander S, Rodriguez D, Fofana F, Filipenko D, Ulianov L, Piketty C, Puelles J. Capturing patient-reported sleep disturbance in atopic dermatitis clinical trials. J Patient Rep Outcomes. 2024 Jul 15;8(1):73. doi: 10.1186/s41687-024-00751-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nemolizumab | Monoclonal antibody | 30 mg | Subcutaneous |