icotrokinra
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icotrokinra
Medical Information
Icotrokinra – Treatment of Ulcerative Colitis (ANTHEM-UC)
Last Updated: 10/09/2025
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- ANTHEM-UC (NCT06049017) is an ongoing clinical trial to evaluate the efficacy and safety of icotrokinra in adult patients with moderately to severely active ulcerative colitis (UC) who had an inadequate response or intolerance to advanced or conventional therapy.1
- Interim results through week 12 of the phase 2b, randomized, double-blind, placebo-controlled, treat-through, 28-week dose-ranging study are reported below.2
CLINICAL DATA
ANTHEM-UC Phase 2b Dose-Ranging Study
Study Population and Design
- Adults with modified Mayo Score (mMS) of 5-9 and a Mayo endoscopy subscore
(MES) ≥22 - History of inadequate response (IR)/intolerance to advanced therapy (tumor necrosis factor [TNF]-alpha inhibitors, vedolizumab, ustekinumab, Janus kinase [JAK] inhibitors, sphingosine type-1 receptor modulators [S1PRM]) or conventional therapy (corticosteroids, azathioprine, mercaptopurine)2
- Patients were stratified by MES 2 or 3 and by history of IR to advanced therapy (yes or no) and randomized 1:1:1:1 to either:2
- Icotrokinra 100 mg by mouth (PO) once daily
- Icotrokinra 200 mg PO once daily
- Icotrokinra 400 mg PO once daily
- Placebo
- Primary endpoint: Clinical response at week 12 (decrease in the mMS by ≥30% and ≥2 points with either ≥1-point decrease in rectal bleeding from baseline or a rectal bleeding score of 0 or 1)2
Results
- Overall, 252 patients were randomized. The mean age and UC duration were 41.6 years and 7.8 years, respectively. At baseline, 37.3% of patients were receiving concomitant corticosteroids and 43.3% had a history of IR to advanced therapy.2
Efficacy
- At week 12, icotrokinra met the primary endpoint at doses of 100 mg, 200 mg, and 400 mg once daily. For details, see Table: Week 12 Endpoints vs Placebo.2
| Placebo N=63 | Icotrokinra 400 mg once daily N=63 | Icotrokinra 200 mg once daily N=62 | Icotrokinra 100 mg once daily N=64 | |
|---|---|---|---|---|
| Primary Endpoint, % Clinical Response | 27.0 | 63.5 P<0.001 | 58.1 P<0.001 | 54.7 P<0.001 |
| Secondary Endpoints, % | ||||
| Clinical Remissiona | 11.1 | 30.2 P=0.006 | 24.2 P=0.054 | 21.9 P=0.092 |
| Symptomatic Remissionb | 19.0 | 46.0 P<0.001 | 41.9 Nominal P-valuec | 53.1 Nominal P-valuec |
| Endoscopic Improvementd | 14.3 | 36.5 P=0.002 | 33.9 Nominal P-valuec | 26.6 P=0.072 |
| HEMIe | 11.1 | 28.6 Nominal P-valuec | 25.8 Nominal P-valuec | 15.6 P=0.419 |
| Abbreviations: CI, confidence interval; HEMI, histologic-endoscopic mucosal improvement; MES, Mayo endoscopic subscore.aClinical remission was defined as stool frequency subscore of 0 or 1, rectal bleeding score of 0, and MES of 0 or 1.bSymptomatic remission was defined as a stool frequency subscore of 0 or 1 and a rectal bleeding score of 0.cNominal P-value vs placebo – these endpoints were not adjusted for multiple comparisons therefore, the P-values are nominal and statistical significance has not been established. dEndoscopic improvement was defined as MES of 0 or 1.eHEMI was defined as histologic remission (absence of neutrophils from the mucosa [both lamina propria and epithelium], no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system) and endoscopic improvement (MES of 0 or 1). | ||||
Safety
- Similar proportions of adverse events, serious adverse events, and serious infections were reported among patients receiving placebo and icotrokinra, see Table: Safety Through Week 12. No opportunistic infections, tuberculosis, malignancies, clinically important hepatic disorders, major adverse cardiovascular events, or deaths were reported in icotrokinra groups through week 12.2
| Placebo N=63 | Icotrokinra 100 mg once daily N=64 | Icotrokinra 200 mg once daily N=62 | Icotrokinra 400 mg once daily N=63 | |
|---|---|---|---|---|
| ≥1 AEs, % | 50.8 | 50.0 | 45.2 | 46.0 |
| SAEs, % | 4.8 | 0 | 3.2 | 1.6 |
| Serious Infections, % | 1.6 | 0 | 0 | 0 |
| AEs leading to discontinuation of study agent, % | 7.9 | 0 | 6.5 | 1.6 |
| Abbreviations: AEs, adverse event; SAEs, serious adverse events.aClinical remission was defined as stool frequency subscore of 0 or 1, rectal bleeding score of 0, and MES of 0 or 1.bSymptomatic remission was defined as a stool frequency subscore of 0 or 1 and a rectal bleeding score of 0.cEndoscopic improvement was defined as MES of 0 or 1.dHEMI was defined as histologic remission (absence of neutrophils from the mucosa [both lamina propria and epithelium], no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system) and endoscopic improvement (MES of 0 or 1). | ||||
Literature Search
A literature search of MEDLINE®
(and /or other resources, including internal/external databases) was conducted on 25 September 2025.
References
| 1 | Janssen Research & Development, LLC. A study of JNJ-77242113 in participants with moderately to severely active ulcerative colitis (ANTHEM-UC). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 September 9]. Available from: https://clinicaltrials.gov/study/NCT06049017 NLM Identifier: NCT06049017. |
| 2 |