PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus
Summary
The primary purpose of the proof of concept study is to elucidate the efficacy of secukinumab in the treatment of adult patients with biopsy-proven lichen planus not adequately controlled by topical therapies, and to assess the safety and tolerability over 32 weeks.
Timeline
- Start
- 2020-07-27
- Primary completion
- 2021-11-16
- Completion
- 2022-05-03
Outcome
Missed primary endpoint
registry AIN457 300 mg Q4W - TP 1 - CLP Cohort vs Placebo - TP 1 - CLP Cohort; Posterior median difference -13.9 (95% CI -44.8 to 19.3) NCT04300296 ↗
registry AIN457 300 mg Q4W - TP 1 - MLP Cohort vs Placebo - TP 1 - MLP Cohort; Posterior median difference 14.1 (95% CI -17.0 to 40.7) NCT04300296 ↗
registry AIN457 300 mg Q4W - TP 1 - LPP Cohort vs Placebo - TP 1 - LPP Cohort; Posterior median difference 6.5 (95% CI -25.4 to 35.4) NCT04300296 ↗
Publications
- Mahon-Smith A, Skingley G, Ayala-Nunes L, Batish A, Sharp R, Naujoks C, Schruf E, Compagno N, Moreno SG. Evaluating the Appropriateness of Existing Health-Related Quality of Life Measures in Lichen Planus. Dermatol Ther (Heidelb). 2023 Nov;13(11):2817-2837. doi: 10.1007/s13555-023-00990-4. Epub 2023 Oct 5.
- Mahon-Smith A, Clifford M, Batish A, Sharp R, Panter C, Naujoks C, Schruf E, Compagno N, Moreno SG. Patient Experience of Lichen Planus: A Qualitative Exploration of Signs, Symptoms, and Health-Related Quality of Life Impacts. Dermatol Ther (Heidelb). 2023 Sep;13(9):2001-2017. doi: 10.1007/s13555-023-00968-2. Epub 2023 Jul 28.
- Miteva M, Nadji M, Billero V, LaSenna C, Nattkemper L, Romanelli P. IL-17 Expression in the Perifollicular Fibrosis in Biopsies From Lichen Planopilaris. Am J Dermatopathol. 2022 Dec 1;44(12):874-878. doi: 10.1097/DAD.0000000000002316. Epub 2022 Sep 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secukinumab | Monoclonal antibody | 300 mg | — |