Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Mar;92(3):495-502.
doi: 10.1016/j.jaad.2024.10.076. Epub 2024 Nov 14.

FRONTIER-2: A phase 2b, long-term extension, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis

Laura K Ferris  1 , Jerry Bagel  2 , Yu-Huei Huang  3 , Andrew E Pink  4 , Stephen K Tyring  5 , Georgios Kokolakis  6 , Amy M DeLozier  7 , Shu Li  8 , Yaung-Kaung Shen  8 , Charles Iaconangelo  8 , Takayuki Ota  7 , Robert Bissonnette  9
Affiliations
Free article
Clinical Trial

FRONTIER-2: A phase 2b, long-term extension, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis

Laura K Ferris et al. J Am Acad Dermatol. 2025 Mar.
Free article

Abstract

Background: More patients with moderate-to-severe plaque psoriasis achieved responses with JNJ-77242113, a targeted oral peptide inhibiting interleukin-23 receptor signaling, versus placebo (PBO) at week (W)16 of the phase 2 FRONTIER-1 study.

Objective: FRONTIER-2, a long-term extension of FRONTIER-1, evaluated JNJ-77242113 through 1 year.

Methods: FRONTIER-1 participants received JNJ-77242113 at doses from 25 mg daily to 100 mg twice daily or PBO through W16. Patients completing FRONTIER-1 could enroll in FRONTIER-2 and continue JNJ-77242113 at the same dose through W52. Those on PBO crossed over to JNJ-77242113 100 mg daily for W16-52. Safety follow-up continued through W56.

Results: Most (89%) FRONTIER-1 patients continued to FRONTIER-2. Across outcomes, response rates were maintained from W16-52. The highest response rates generally occurred with JNJ-77242113 100 mg twice daily. At W52, 76% of patients achieved up to 75% improvement in Psoriasis Area and Severity Index (PASI75) with 100 mg twice daily; rates of clear or almost clear skin were 64% (PASI90), 74% (Investigator's Global Assessment 0/1), 40% (PASI100), and 43% (Investigator's Global Assessment 0). From W16-56, 59% of JNJ-77242113-treated patients had ≥1 adverse events. Serious adverse events, considered unrelated to treatment by investigators, occurred in 4% of patients.

Limitations: The study was limited by the small number of patients in each treatment group and the descriptive nature of the longer-term data.

Conclusion: Rates of skin clearance with JNJ-77242113 were durable to 1 year and no safety signals were identified.

Keywords: IL-23; JNJ-77242113; long-term extension; oral; phase 2; plaque psoriasis.

PubMed Disclaimer

Conflict of interest statement

Conflicts of interest Dr Ferris served as an investigator for AbbVie, Acelyrin, Amgen, Apogee, Arcutis, Aristea, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, DermTech, Eli Lilly, Galderma, GRAIL, Incyte, Janssen, Leo Pharma, Moberg, Mobius, Novartis, Regeneron, SkinAnalytics, Takeda, and UCB; consultant for AbbVie, Amgen, Apogee, Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, DermTech, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, and Takeda; speaker for AbbVie, Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, and Regeneron. Dr Bagel has research funds payable to Psoriasis Treatment Center from AbbVie, Amgen, Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Corrona, Dermavant, Dermira/UCB, Eli Lilly, Glenmark, Janssen, Kadmon, Leo Pharma, Lycera, Menlo, Novartis, Pfizer, Regeneron, Sun, Taro, and Valeant; consultant/speaking fees from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Sun, and Valeant; and fees for speaking from AbbVie, Celgene, Eli Lilly, Janssen, and Novartis. Dr Huang has conducted clinical trials for or received honoraria as a consultant for AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Johnson & Johnson Innovative Medicine, Novartis, and Pfizer Pharmaceuticals. Dr Pink served as an investigator, advisor, speaker, or received educational support from AbbVie, Almirall, Amgen, BI, BMS, Galderma, Janssen, Johnson & Johnson, Leo, Lilly, Novartis, Pfizer, Sanofi, and UCB. Dr Tyring has received grants, consultant/speaker honoraria (paid to institution) from AbbVie, Agenus, AiCuris GmbH, Almirall, Amgen, Bayer, BMS, Demira, Dr Reddy's Laboratory, Eli Lilly, Foamix Pharma, Galderma, Genocea Biosciences, GlaxoSmithKline Immunology, Glenmark Pharma, IQVIA, Janssen Research & Development, Kiniksa Pharma, LEO Laboratories, Menlo Therapeutics, Merck, Novartis, Nycomed Amersham, Parexel, Quintiles Pharma, Regeneron Pharma, Sanofi, Trevi Therapeutics, UCB, and Vical. Dr Kokolakis is or has acted as a speaker and/or advisory board member for honoraria from AbbVie, Abbott, Actelion Pharmaceuticals, Amgen, Basilea Pharmaceutica, Bayer, Biogen IDEC, Boehringer, Bristol Myers Squibb, Celgene, Hexal, Janssen-Cilag, LEO Pharma, Lilly, MSD, Mylan, Novartis, Parexel, Pfizer, Sanofi-Aventis, Takeda, and UCB. Drs DeLozier, Li, Shen, Iaconangelo, and Ota are employees of Janssen Research & Development, LLC; employees may own stock/stock options in Johnson & Johnson. Dr Bissonnette is an advisory board member, consultant, speaker, and/or investigator for and received honoraria and/or grants from AbbVie, Alumis, Amgen, Arcutis, Bausch Health, BMS/Celgene, Boston Pharma, Dermavant, Eli Lilly, Janssen, LEO Pharma, Nimbus, Novartis, Pfizer, Regeneron, UCB, VentyxBio, and Xencor; also, an employee and shareholder of Innovaderm Research.

Publication types