Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis

Summary

A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165

Timeline

Start

2016-11-15

Primary completion

2017-11-16

Completion

2017-11-16

Outcome

Met primary endpoint

registry NUMBER BMS-986165 3MG QD: 38.6 (24.4 to 54.5) Percentage NCT02931838 ↗

registry analysis (superiority test); Placebo vs BMS-986165 3MG QD; p = 0.0003; Chi-squared; note: Nominal p-value NCT02931838 ↗

Publications

• Catlett IM, Gao L, Hu Y, Banerjee S, Krueger JG. Pharmacodynamic Response to Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in a Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled Psoriasis Trial. Dermatol Ther (Heidelb). 2024 Oct;14(10):2827-2839. doi: 10.1007/s13555-024-01262-5. Epub 2024 Sep 16.
• Thaci D, Strober B, Gordon KB, Foley P, Gooderham M, Morita A, Papp KA, Puig L, Menter MA, Colombo MJ, Elbez Y, Kisa RM, Ye J, Napoli AA, Wei L, Banerjee S, Merola JF, Gottlieb AB. Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. Dermatol Ther (Heidelb). 2022 Feb;12(2):495-510. doi: 10.1007/s13555-021-00649-y. Epub 2022 Jan 13.
• Catlett IM, Hu Y, Gao L, Banerjee S, Gordon K, Krueger JG. Molecular and clinical effects of selective tyrosine kinase 2 inhibition with deucravacitinib in psoriasis. J Allergy Clin Immunol. 2022 Jun;149(6):2010-2020.e8. doi: 10.1016/j.jaci.2021.11.001. Epub 2021 Nov 10.
• Papp K, Gordon K, Thaci D, Morita A, Gooderham M, Foley P, Girgis IG, Kundu S, Banerjee S. Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis. N Engl J Med. 2018 Oct 4;379(14):1313-1321. doi: 10.1056/NEJMoa1806382. Epub 2018 Sep 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CRAVACITINIB	Small molecule	3 mg	Oral
Subject	CRAVACITINIB	Small molecule	6 mg	Oral
Subject	CRAVACITINIB	Small molecule	12 mg	Oral

Indications