Johnson & Johnson has halted a Phase IIb clinical trial evaluating JNJ-95475939 (JNJ-5939) for atopic dermatitis after interim results did not meet the required efficacy standards. The DUPLEX-AD study, which began in February 2025, enrolled 240 participants with moderate-to-severe atopic dermatitis and compared the investigational drug to a placebo.
The decision to stop the trial followed a planned interim analysis that met criteria for early termination due to insufficient efficacy. In a statement on December 26, Johnson & Johnson said the asset failed to reach the "high-bar efficacy" set for its atopic dermatitis programs.
JNJ-5939 is a bispecific antibody designed to target IL-4 and IL-31, two Type II cytokines involved in inflammation and itch associated with atopic dermatitis. IL-4 is already targeted by Dupixent, an established treatment from Regeneron and Sanofi.
David Lee, global immunology therapeutic area head at Johnson & Johnson, previously explained: “IL-31 [is] a big driver of itch,” noting that single-target drugs against this cytokine have shown “some modest efficacy” in treating atopic dermatitis. He referenced Galderma’s anti-IL-31 antibody Nemluvio, which received FDA approval for this indication in December 2024.
John Reed, executive vice president for innovative medicine R&D at Johnson & Johnson, discussed the rationale behind JNJ-5939’s dual targeting approach: “break through efficacy ceilings of the monotherapies.”
With JNJ-5939 discontinued for this indication, attention will shift to other assets within Johnson & Johnson's pipeline. The company currently lists JNJ-7528 as its only other public candidate for atopic dermatitis; it started Phase I trials in 2024 and plans to begin Phase IIb enrollment next month.
In addition to internal development efforts, Johnson & Johnson acquired Proteologix in May 2024 for $850 million. This acquisition included rights to another bispecific antibody targeting IL-13 and TSLP—targets also pursued by Amgen and AstraZeneca’s Tezspire—which was ready for Phase I entry when acquired. David Lee stated last November that this program was “progressing at pace, getting into the clinic.”
Johnson & Johnson also holds an exclusive license to Kaken Pharmaceutical’s STAT6 program after reaching an agreement in late 2024. Plans were underway to start clinical testing of this oral drug candidate in 2025.
