Johnson & Johnson (J&J) has reported new data from the Phase III ICONIC-TOTAL trial, which evaluated icotrokinra, an oral peptide, in treating plaque psoriasis (PsO).
The randomised clinical trial focused on the adult and adolescent patients aged 12 and above, having a body surface area as low as 1% and with at least moderate psoriasis affecting critical skin sites.
The study is designed to assess the safety and efficacy of the therapy against placebo for treating plaque PsO in 311 subjects who have at least moderate severity affecting areas such as scalp, genital and/or hands and feet), with overall Investigator’s Global Assessment (IGA) score of 0 or 1 with a minimum of a two-grade improvement as the primary goal.
The primary endpoint was met, with 57% of subjects treated with the therapy achieving clear or almost clear skin at the mark of week 16 based on the IGA score, against the 6% in the placebo group.
J&J noted that the therapy also showed high skin clearance rates in subjects having scalp and genital psoriasis, with 66% and 77% of patients, respectively, achieving clear or almost clear skin, compared to 11% and 21% with placebo.
In a smaller subset of subjects having hand/foot psoriasis, the therapy’s treatment demonstrated a numerically higher rate of skin clearance, with 42% achieving a hand and/or foot Physician’s Global Assessment (hf-PGA)score of clear (0) or almost clear skin (1) against 26% for placebo.
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By GlobalDataThe safety profile of the therapy was found to be favourable, without any safety signals observed.
Johnson & Johnson Innovative Medicine vice-president and immunodermatology disease area lead Liza O’Dowd said: “These new findings build upon the impressive scalp psoriasis results seen in ICONIC-LEAD and strengthen the breadth of data demonstrating the potential for icotrokinra to shift the treatment paradigm in moderate-to-severe plaque psoriasis, by offering a combination of skin clearance and favourable safety in a once daily pill.”
This study is part of the larger ICONIC clinical development programme, which began in the fourth quarter of 2023 with two trials, ICONIC-LEAD and ICONIC-TOTAL, under a licence and partnership agreement between J&J’s Janssen Biotech and Protagonist Therapeutics.
Plaque PsO is stated to be a chronic immune-mediated condition leading to painful, inflamed, scaly plaques on the skin.
Also known as JNJ-77242113 or JNJ-2113, icotrokinra is tailored to selectively block the Interleukin-23 (IL-23) receptor, which is a key player in the inflammatory response associated with plaque PsO, ulcerative colitis, and other IL-23-mediated conditions.
Last month, Johnson & Johnson reported data from the ICONIC-LEAD trial’s subgroup analysis, assessing icotrokinra in treating moderate-to-severe plaque PsO.
