On Monday, Protagonist Therapeutics, Inc ( PTGX ). announced topline results from ANTHEM-UC Phase 2b study of icotrokinra (JNJ-2113) in adults with moderately to severely active ulcerative colitis (UC).
The study conducted by Protagonist’s collaboration partner, Johnson & Johnson ( JNJ ), met its primary endpoint of clinical response in all icotrokinra dose groups evaluated.
Additionally, the study demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic improvement at Week 12.
All three doses of once daily icotrokinra met the primary endpoint of clinical response at Week 12.
At Week 12, patients treated with the highest dose of icotrokinra achieved a response rate of 63.5% versus 27.0% for placebo.
30.2% of patients treated with the highest dose of icotrokinra demonstrated clinical remission at Week 12, compared to 11.1% of patients who received placebo.
Clinical remission and response rates continued to improve through Week 28.
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On Saturday, Johnson & Johnson ( JNJ ) released new icotrokinra data from its comprehensive Phase 3 program in adults and adolescents 12 years and older with moderate-to-severe plaque psoriasis (PsO).
Data from the Phase 3 ICONIC-LEADa study, presented at the 2025 American Academy of Dermatology Annual Meeting, show once daily icotrokinra demonstrated significant skin clearance and a favorable safety profile.
In the ICONIC-LEAD study, nearly two-thirds (65%) of patients treated with once daily icotrokinra achieved an Investigator’s Global Assessment (IGA)b score of 0/1 (clear or almost clear skin) and 50% achieved a Psoriasis Area and Severity Index (PASI)c 90 response, compared to 8% and 4% receiving placebo, respectively (P