Icotrokinra for Psoriasis: A Small Peptide Poised To Take On the Bigger Biologics | AAD 2025

Dermatology, and particularly the treatment of the many conditions caused by errant inflammation and immune reactions, has been revolutionized by the proliferation of safe and effective monoclonal antibodies.

Johnson & Johnson’s icotrokinra breaks that mold, and in conjunction with the presentation of positive results from a phase 3 trial, the company announced that today it was planning to launch a head-to-head trial of its promising plaque psoriasis drug against its star biologic, Stelara (ustekinumab), which is now facing biosimilar competition.

There are some small-molecule drugs used for skin conditions. Johnson & Johnson has already started trials comparing icotrokinra with Bristol Myers Squibb’s Sotyktu (deucravacitinib), a small-molecule drug used to treat plaque psoriasis.

Robert Bissonnette, M.D., M.Sc.

Robert Bissonnette, M.D., M.Sc., described icotrokinra’s mechanism of action as “interesting” in his presentation of the data from the phase 3 ICONIC-LEAD trial this morning at a late-breaking research session of the 2025 meeting of the American Academy of Dermatology (AAD) in Orlando, Florida.

“It is fairly novel in dermatology. It is a small peptide, so it is not a protein,” said Bissonnette, chairman at Innovaderm Research in Montreal, Canada. Bissonnette said icotrokinra blocks attraction between interleukin (IL) 23 and its receptor, which gives it the virtue of being specific. IL-23 is a cytokine that plays a crucial role in inflammatory processes.

Bissonnette’s presentation of the data from the ICONIC-LEAD trial was expected to be one of the highpoints of the AAD meeting. Johnson & Johnson has launched numerous trials of icotrokinra, so there will be a stream of findings about the drug in the months and years ahead.

Plaque psoriasis is a chronic immune system-mediated disease that causes an overproduction of skin cells. The result of that overproduction is scaly plaques that can be itchy or painful. A study of the prevalence of psoriasis published in JAMA Dermatology in 2021 concluded that the condition affects 3% of the adult population in the U.S., or approximately 7.5 million people.

In the ICONIC-LEAD trial, patients with plaque psoriasis were randomly assigned in a 2 to 1 ratio to either take icotrokinra daily or a placebo pill. The trial investigators ended up enrolling 456 patients into the icotrokinra group and 228 into the placebo group. The co-primary end points were an Investigator’s Global Assessment (IGA) score of 0 or 1 and a Psoriasis Area and Severity Index (PASI) 90 response, both of which are commonly used to measure the response to psoriasis drugs.

Data shared by Bissonnette this morning showed that at week 16 of the trial, 65% of those assigned to the icotrokinra group had an IGA score of 0 or 1 compared with 8% of those in the placebo group. Similarly, 50% in the icotrokinra group had a PASI 90 response compared with 4% in the placebo group.

Bissonnette also showed data that the improvement among those in the icotrokinra group continued between week 16 and week 24 of the trial. By week 24, the proportion of those in the icotrokinra group with a PASI 90 response had increased to 65%, and 40% had a PASI 100 response. The trend was similar for IGA.

In an interview with HCP Live, Bissonnette said that the response to agents that interfere with IL-23 tends to peak at about six months. He said he was encouraged by the data showing that people with plaque psoriasis continued to respond to icotrokinra in the week 16-to-week 24 interval.