Ucenprubart is an agonistic antibody to CD200R with the potential to treat inflammatory skin disease: preclinical development and a phase 1 clinical study

Anja Koester (), Derrick R. Witcher, Mark Lee, Stephen J. Demarest, Scott Potter, Katie Werle, Scott Bauer, Diana Ruiz, Laurent Malherbe, Josh Poorbaugh, Andrew Glasebrook, Christoph Preuss, Gourab Datta, Ziqiao Wang, Jack Knorr, David Manner, Dipak Patel, Carsten Schmitz, Paul Klekotka and Ajay Nirula
Additional contact information
Anja Koester: Immunology Research
Derrick R. Witcher: Biotechnology
Mark Lee: Progressive Clinical Research
Stephen J. Demarest: Biotechnology
Scott Potter: Immunology Research
Katie Werle: Immunology Research
Scott Bauer: Biotechnology
Diana Ruiz: Biotechnology
Laurent Malherbe: Toxicology
Josh Poorbaugh: Biotechnology
Andrew Glasebrook: Immunology Research
Christoph Preuss: Biotechnology
Gourab Datta: Biotechnology
Ziqiao Wang: Biotechnology
Jack Knorr: Biotechnology
David Manner: Biotechnology
Dipak Patel: Immunology Research
Carsten Schmitz: Immunology Research
Paul Klekotka: Immunology Research
Ajay Nirula: Immunology Research

Nature Communications, 2025, vol. 16, issue 1, 1-15

Abstract: Abstract CD200R is a checkpoint inhibitory receptor central to the pathogenesis of inflammatory skin disease. Here we describe the development and phase 1 clinical study (NCT03750643) of ucenprubart, a CD200R agonist antibody to downregulate immune system inflammation. Preclinical studies find ucenprubart inhibiting Fcγ receptor-induced cytokine secretion from myeloid cells in vitro and demonstrating efficacy in a mouse contact hypersensitivity model. The randomized, placebo-controlled, NCT03750643 trial assesses safety and pharmacokinetics in healthy subjects, and efficacy in atopic dermatitis patients. The primary efficacy outcome is the proportion of patients achieving Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) 0 or 1 with ≥2-point improvement from baseline at week 12. Secondary outcomes are proportions of patients achieving the primary outcome and mean changes in Eczema Area and Severity Index (EASI) and SCORing Atopic Dermatitis (SCORAD) across weeks 1 through 12, and cutoffs at week 12. Sixty-two healthy participants and 40 patients are enrolled. No serious adverse events or discontinuations due to adverse events is seen with ucenprubart. The primary endpoint is not met; however, overall improvements are observed in EASI-75 and SCORAD through 12 weeks. CD200R may be a promising therapeutic target for treating autoimmune disease, including inflammatory skin diseases.

Date: 2025
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DOI: 10.1038/s41467-025-59147-w

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