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icotrokinra

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Icotrokinra – Treatment of Ulcerative Colitis (ANTHEM-UC)

Last Updated: 11/03/2025

SUMMARY  

  • ANTHEM-UC (NCT06049017) is an ongoing phase 2b 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 
  • Results through week 28 of the phase 2b, randomized, double-blind, placebo-controlled, treat-through dose-ranging study are reported below.2,3 

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) ≥22,3 
  • 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)2,3 
  • 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:2,3 
    • 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)2,3 
  • The study was powered to detect a treatment difference between icotrokinra 400 mg and placebo for the primary endpoint; it was not powered for the secondary or exploratory endpoints.2 
  • Patients meeting inadequate response criteria at week 16 had a treatment adjustment:3
    • Placebo patients switched to icotrokinra 400 mg PO once daily
    • Icotrokinra patients had a sham adjustment
  • All patients meeting inadequate response criteria were considered non-responders moving forward.3

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 
  • At week 16, 38.1% of patients were nonresponders.3
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 

Week 12 Endpoints vs Placebo2 
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: 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).
  • Compared to placebo, all icotrokinra doses demonstrated clinically meaningful rates of clinical response, clinical remission, symptomatic remission, endoscopic improvement and HEMI at week 28.
  • Relative to week 12 outcomes, rates of clinical response, clinical remission, endoscopic improvement, and HEMI continued to increase through week 28 in each icotrokinra group, see Table: Week 28 Endpoints vs Placebo.3

Week 28 Endpoints vs Placebo3
Placebo
N=63
Icotrokinra
400 mg once daily
N=63
Icotrokinra
200 mg once daily
N=62
Icotrokinra
100 mg once daily
N=64
Endpoints, %
Clinical Response
25.4

66.7
Nominal P-valuec
62.9
Nominal P-valuec
60.9
Nominal P-valuec
Clinical Remissiona
9.5
31.7
Nominal P-valuec
33.9
Nominal P-valuec
40.6
Nominal P-valuec
Symptomatic Remissionb
20.6
52.4
Nominal P-valuec
53.2
Nominal P-valuec
51.6
Nominal P-valuec
Endoscopic Improvementd
11.1
38.1
Nominal P-valuec
38.7
Nominal P-valuec
50.0
Nominal P-valuec
HEMIe
11.1
33.3
Nominal P-valuec
30.6
Nominal P-valuec
40.6
Nominal P-valuec
Abbreviations: 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
  • Through week 12, no opportunistic infections, tuberculosis, malignancies, clinically important hepatic disorders, major adverse cardiovascular events, or deaths were reported in icotrokinra groups.2
  • Similar proportions of adverse events and serious adverse events were reported among patients receiving placebo and icotrokinra, see Table: Safety Through Week 28.3 
  • Through week 28, no serious or opportunistic infections, tuberculosis, malignancies, clinically important hepatic disorders, venous thromboembolism (VTE), major adverse cardiovascular events (MACE), or deaths were reported with icotrokinra.3

Safety Through Week 283
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, %
61.9
65.6
66.1
60.3
SAEs, %
9.5
0
4.8
1.6
AEs leading to discontinuation of study agent, %
11.1
0
6.5
3.2
Abbreviations: AEs, adverse event; SAEs, serious adverse events.

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File
(and /or other resources, including internal/external databases) was conducted on 23 October 2025.

 

References

Show
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 October 10]. Available from: https://clinicaltrials.gov/study/NCT06049017 NLM Identifier: NCT06049017.  
2 Abreu M, Siegmund B, Surace L, et al. Icotrokinra, a targeted oral peptide that selectively blocks IL-23 receptor activation, in moderately to severely active ulcerative colitis: week 12 results from the phase 2b, randomized, double-blind, placebo-controlled, treat-through, dose-ranging ANTHEM-UC trial [abstract]. UEG. 2025;13:172-173. Abstract OP206.  
3 Jairath V, Siegmund B, Surace L, et al. Efficacy and safety of icotrokinra, a targeted oral peptide that selectively blocks IL- 23 receptor activation, in ulcerative colitis: results from week 28 of ANTHEM-UC, a phase 2b dose-ranging trial. Abstract presented at: American College of Gastroenterology; October 24-29, 2025; Phoenix, Arizona.