Setback in Autoimmune Bispecifics: J&J Halts IL-4R/IL-31 Bispecific Antibody JNJ-95475939 Due to Suboptimal Efficacy in Phase IIb Atopic Dermatitis Trial

▎Armstrong

On December 26, 2025, Johnson & Johnson announced the early termination of the Phase 2b clinical trial for the IL-4R/IL-31 dual antibody JNJ-95475939 in the treatment of atopic dermatitis. The reason was that the study did not meet the pre-set high standard efficacy threshold to support continued development of the project.

In May 2024, Johnson & Johnson acquired Yellow Jersey Therapeutics, a wholly-owned subsidiary of Numab, for $1.25 billion. Its core pipeline is an IL-4R/IL-31 bispecific antibody for the treatment of atopic dermatitis.

Summary

In recent years, transactions in the autoimmune field have been particularly active, with long-acting formulations and bispecific/multispecific antibodies being the most important directions for iterative development. Johnson & Johnson has been especially proactive in the layout of bispecific antibodies for autoimmune diseases, including acquiring IL-4R/IL-31 bispecific antibodies through the acquisition of Yellow Jersey, and obtaining IL-13/IL-TSLP and IL-13/IL-22 bispecific antibodies via the acquisition of Proteologix. The positioning of bispecific antibodies in autoimmune diseases is naturally to achieve efficacy surpassing that of single-target therapies; otherwise, there would be no point in continuing their development. Besides, issues such as immunogenicity also pose significant challenges in the development of bispecific/multispecific antibodies for autoimmune diseases.