drugset / Trial / NCT04999839
Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis
Phase 2
Completed
259 enrolled
Takeda
Innovaderm Research Inc. · collabNimbus Lakshmi, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase 2b, randomized, multicenter, double-blind, placebo-controlled, multiple-dose study designed to evaluate the efficacy, safety, and tolerability of NDI-034858 in participants with moderate to severe plaque psoriasis. This study will also evaluate the plasma concentrations of NDI-034858 and explore the immune response to NDI-034858 in participants with moderate to severe plaque psoriasis.
Timeline
- Start
- 2021-08-11
- Primary completion
- 2022-08-19
- Completion
- 2022-09-12
Publications
- Elbuluk N, Armstrong AW, Vender R, Bhutani T, Green L, Ferris LK, Laquer V, Moore A, Weisman J, Zhang W, Winkelman W, Gooderham MJ. Zasocitinib (TAK-279), a Highly Selective Oral TYK2 Inhibitor, Demonstrates Skin Clearance in Patients with Moderate-to-Severe Plaque Psoriasis: Post Hoc Analyses of a Randomized Phase IIb Trial. Dermatol Ther (Heidelb). 2026 Jun;16(6):3215-3234. doi: 10.1007/s13555-026-01738-6. Epub 2026 May 16.
- Armstrong AW, Gooderham M, Lynde C, Maari C, Forman S, Green L, Laquer V, Zhang X, Franchimont N, Gangolli EA, Blau J, Zhao Y, Zhang W, Srivastava B, Heap G, Papp K. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2024 Oct 1;160(10):1066-1074. doi: 10.1001/jamadermatol.2024.2701.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zasocitinib | Small molecule | 2 mg | Oral |
| Subject | Zasocitinib | Small molecule | 5 mg | Oral |
| Subject | Zasocitinib | Small molecule | 15 mg | Oral |
| Subject | Zasocitinib | Small molecule | 30 mg | Oral |