ICOTYDE met the primary endpoint, with 58% of patients achieving an American College of Rheumatology 20 (ACR20) response compared with 41% receiving placebo at Week 16.2 Safety findings were consistent with the established safety profile of ICOTYDE, with no new safety signals identified. These results are being presented as a late-breaking poster at the American College of Rheumatology (ACR) Convergence 2026.
Psoriatic arthritis is a chronic, immune-mediated inflammatory disease that can affect both the joints and skin.3,4 Nearly 30 percent of people with plaque psoriasis also develop psoriatic arthritis.5,6 It can cause pain, stiffness and swelling in and around the joints, along with the skin lesions associated with plaque psoriasis.7 Because inflammation can lead to progressive disease, there remains a need for treatment approaches that address the multiple ways psoriatic arthritis can affect patients. In clinical studies, ACR response is a composite measure whereby ACR20 represents ≥20% improvement in tender joint count, swollen joint count and other measures of disease activity. ACR50 and ACR70 use the same framework but represent ≥50% and ≥70% improvement, respectively.
"The significant joint responses observed in this study show the exciting potential for ICOTYDE, a targeted oral peptide therapy, to open an entirely new chapter in treating psoriatic arthritis with an oral option," said Joseph F. Merola, MD MMSc, Rheumatologist, Dermatologist, President of the Psoriasis and Psoriatic Arthritis Multicenter Advancement Network, Co-President of the Group for Research in Psoriasis and Psoriatic Arthritis and President of the Rheumatologic Dermatology Society.d "Effective management of psoriatic arthritis requires addressing both joint and skin disease, and patients continue to need treatment options that can provide meaningful improvement across both."
ICOTYDE demonstrated joint and skin improvements through Week 242
The Phase 3 ICONIC-PsA 1 study met its primary endpoint, with a significantly higher proportion of patients receiving ICOTYDE 200 mg achieving an American College of Rheumatology 20 (ACR20)c response compared with placebo (58% vs. 41%) at Week 16. Numerically higher proportions of patients receiving ICOTYDE also achieved ACR50 (29% vs. 16%) and ACR70 (13% vs. 5%). Among patients with qualifying skin involvement, 57% receiving ICOTYDE achieved clear or almost clear skin (Investigator's Global Assessment [IGA] 0/1)e, compared with 14% receiving placebo (nominal p<0.001), while 37% achieved a Psoriasis Area and Severity Index (PASI)f score of 90 compared with 6% receiving placebo (nominal p<0.001).
Response rates with ICOTYDE 200 mg continued to increase numerically through Week 24, with 69% of patients achieving ACR20, 40% achieving ACR50, and 18% achieving ACR70. Among patients with qualifying baseline skin involvement (BSA)g, 64% achieved clear or almost clear skin (IGA 0/1) and 56% achieved PASI 90. Safety data through Week 24 were consistent with the established safety profile of ICOTYDE, with no new safety signals identified.
"Many people living with psoriatic arthritis are still searching for treatments that can effectively address the full burden of their disease," said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "These new findings underscore the potential of ICOTYDE to meaningfully improve outcomes in psoriatic arthritis and add to the growing body of evidence across psoriatic disease."
About the ICONIC clinical development program
Phase 3 studies investigating ICOTYDE in active psoriatic arthritis include:
ICONIC-PsA 1 (NCT06878404) is a RCT to evaluate the efficacy and safety of ICOTYDE compared to placebo for the treatment of biologic-naïve participants with active PsA.11
ICONIC-PsA 2 (NCT06807424) is a RCT to evaluate the efficacy and safety of ICOTYDE compared to placebo for the treatment of biologic-experienced and biologic-naïve participants with active PsA.12
Pivotal Phase 3 studies in moderate-to-severe plaque psoriasis include:
- ICONIC-LEAD (NCT06095115) is a RCT to evaluate the efficacy and safety of ICOTYDE compared with placebo in participants with moderate-to-severe plaque PsO.13
- ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of ICOTYDE compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet).14
- ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) are RCTs to evaluate the efficacy and safety of ICOTYDE compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.15,16
About psoriatic arthritis
Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO).20,3,4 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.21 Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.22 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.23 Studies show up to 30% of people with plaque PsO also develop PsA.5,6
About ICOTYDE® (icotrokinra)
ICOTYDE® (icotrokinra) is the only targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque PsO.1,24,25 ICOTYDE binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, precise inhibition of IL-23 signaling in human T cells.26 Clinical significance of these findings is unknown.
ICOTYDE is currently approved in the U.S. for the treatment of moderate-to-severe plaque PsO in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. Patients on ICOTYDE take one pill, once daily upon waking with water on an empty stomach, at least 30 minutes before eating.27
ICOTYDE was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop ICOTYDE in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.28,29,30
ICOTYDE is also being studied in active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease.12,13,14
WHAT IS ICOTYDE (icotrokinra)?
ICOTYDE 200 mg is a prescription medicine used to treat moderate to severe plaque psoriasis in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg), who may benefit from taking injections or medicines by mouth (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
What is the most important information I should know about ICOTYDE?
Infections. Medicines that interact with the immune system, such as ICOTYDE, may lower your ability to fight infections and may increase your risk of infections. Your healthcare provider may check you for infections and tuberculosis (TB) before starting treatment and may treat you for TB before you begin treatment with ICOTYDE if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with ICOTYDE.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
For more information please visit, https://www.jnj.com/
