Johnson & Johnson Initiates Head-to-Head Phase III Trial of IL-23R Antagonist JNJ-77242113 Versus TYK2 Inhibitor Deucravacitinib in Moderate-to-Severe Plaque Psoriasis

On November 22, Johnson & Johnson registered a Phase III clinical study (NCT06143878) on ClinicalTrials.gov comparing the IL-23R antagonist JNJ-77242113 with placebo and the TYK2 allosteric inhibitor deucravacitinib for the treatment of moderate to severe plaque psoriasis.

The study is expected to enroll 750 patients. It is expected to commence in February 2024 and complete the primary research by March 2025.

The study has two primary endpoints, which are: 1) JNJ-77242113 and placebo groups: the percentage of participants who achieve an Investigator's Global Assessment (IGA) score of 0 or 1 and show an improvement of greater than or equal to (>=) 2 points from baseline at Week 16; 2) JNJ-77242113 and placebo groups: the percentage of participants achieving a Psoriasis Area and Severity Index (PASI) 90 response at Week 16.

The study set multiple secondary endpoints, including: 1) JNJ-77242113 and deucravacitinib groups: the percentage of participants with an IGA score of 0 or 1 at weeks 16 and 24, and an improvement of >=2 points from baseline; 2) JNJ-77242113 and deucravacitinib groups: the percentage of participants achieving PASI 75/90/100 at weeks 16 and 24, etc.

JNJ-77242113 is an oral IL-23R inhibitor developed by Protagonist Therapeutics. In July 2021, Johnson & Johnson reached an agreement with Protagonist to co-develop three oral IL-23R inhibitors, including JNJ-77242113. In March this year, the Phase IIb FRONTIER 1 study (NCT05223868) of JNJ-77242113 for the treatment of moderate to severe plaque psoriasis reported successful results.

At week 16, the proportion of patients achieving PASI75 in the JNJ-77242113 treatment groups was as follows: 25mg QD 37.2%, 50mg QD 58.1%, 25mg BID 51.2%, 100mg QD 65.1%, 100mg BID 78.6%, and 9.3% in the placebo group.

The proportion of patients achieving PASI90 at Week 16 was: JNJ-77242113 treatment group 25mg QD 25.6%, 50mg QD 51.2%, 25mg BID 26.8%, 100mg QD 46.5%, 100mg BID 59.5%, and placebo group 2.3%.

Currently, Johnson & Johnson has two IL-23 pathway products: ustekinumab, an anti-IL-12/IL-23 monoclonal antibody, and guselkumab, an anti-IL-23 monoclonal antibody. Among them, ustekinumab has shown very steady growth, with sales reaching $9.723 billion in 2022, just a step away from becoming a $10 billion blockbuster.

Targeting the IL-23 pathway, Johnson & Johnson's development strategy is to develop oral IL-23 receptor antagonists and other oral products targeting the IL-23 pathway based on the company’s existing assets, in order to further improve patient compliance.

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