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icotrokinra

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Icotrokinra – Occurrence of Gastrointestinal Adverse Events in Patients with Plaque Psoriasis

Last Updated: 01/29/2026

SUMMARY

  • Icotrokinra (JNJ-77242113) is a targeted oral peptide that selectively binds the interleukin-23 (IL-23) receptor and inhibits IL-23 pathway signaling.1 
  • The safety of icotrokinra in patients with moderate to severe plaque psoriasis (PsO) was evaluated in the ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 phase 3 clinical trials. The following summarizes the incidence of gastrointestinal adverse events (AEs) across these trials.1-5 
    • The incidence rate of gastrointestinal AEs reported in the icotrokinra group was 11% through week 52 in ICONIC-LEAD, 10% through week 52 in ICONIC-TOTAL, and 9% through week 24 in the ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 combined safety analysis.

CLINICAL DATA

ICONIC-LEAD

Bissonnette et al (2025)1 and Soung et al (2025)2 evaluated the efficacy and safety of oral icotrokinra 200 mg daily in patients ≥12 years of age with moderate to severe plaque PsO in an ongoing phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled study with randomized withdrawal and retreatment (NCT06095115).


Incidence of Gastrointestinal AEs Through Week 52 in ICONIC-LEAD1,2 
PBO-Controlled
(Adults & Adolescents)
Active Treatment
(Adults & Adolescents)
ICO Responders Re-Randomized at W24 (Adults)
ICO
N=456
PBO
N=228
ICO
N=456
ICOa
N=213
ICO→ICO N=168
ICO→PBOb N=172
Treatment period
W0-16
W0-52
W16-52
W24-52
W24-52
Mean weeks of follow-up
15.9
15.8
43.4
35.3
27.7
27.8
Gastrointestinal AEc, n (%)
26 (6)
13 (6)
51 (11)
9 (4)
7 (4)
8 (5)
Abbreviations: AE, adverse event; ICO, icotrokinra; PBO, placebo; W, week.
aIncludes data after week 16 for PBO-randomized patients who crossed over to receive ICO.bCombined withdrawal and retreatment group.cBased on gastrointestinal disorders System Organ Class.
  • From weeks 0 through 16, the total patient-years (PY) of follow up was 139.2 and 68.9 for the icotrokinra and PBO groups, respectively.1 
    • The incidence of gastrointestinal AEs per 100 PY was 19.4 (95% confidence interval [CI], 12.7-28.5) and 19.6 (95% CI, 10.5-33.6), respectively.
  • Through week 16, the most common gastrointestinal AE in the icotrokinra group was nausea (n=8 [2%], versus n=1 [<1%] in the PBO group).6 

ICONIC-TOTAL

Gooderham et al (2025)3 and Lain et al (2025)4 evaluated the efficacy and safety of oral icotrokinra 200 mg daily in patients ≥12 years of age with moderate to severe plaque PsO affecting special sites (scalp, genitals, and/or palms of the hands and soles of the feet) in an ongoing phase 3, multicenter, randomized, double-blind, PBO-controlled study (NCT06095102).


Incidence of Gastrointestinal AEs Through Week 52 in ICONIC-TOTAL4 
PBO-Controlled
Crossover
Active Treatment
ICO
N=208
PBO
N=103
PBO→ICO
N=92
ICO
N=208
ICO Combineda N=300
Treatment period
W0-16
W16-52
W0-52
Mean weeks/total PY of follow-up
16.0/63.6
15.6/30.8
36.2/63.9
49.3/196.4
45.3/260.2
Gastrointestinal AE, n (%)
15 (7)
8 (8)
7 (8)
21 (10)
28 (9)
Incidence/100 PY (95% CI)b
25 (12-37)
27 (8-46)
11 (3-20)
12 (7-17)
12 (7-16)
Abbreviations: AE, adverse event; CI, confidence interval; ICO, icotrokinra; PBO, placebo; PY, patient-years; W, week.
aIncludes data for ICO-randomized patients through W52 and for PBO-to-ICO patients from W16 through W52.bCIs were based on a Wald statistic using the normal assumption.
  • Through week 16, the most common gastrointestinal AE in the icotrokinra group was diarrhea (n=8 [3.8%], versus n=4 [3.9%] in the PBO group).7 

ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2

Stein Gold et al (2025)5 evaluated the efficacy and safety of oral icotrokinra 200 mg daily in adults with moderate to severe plaque PsO in 2 ongoing, phase 3, multicenter, randomized, double-blind studies comparing icotrokinra with PBO and deucravacitinib (NCT06143878 and NCT06220604).


Incidence of Gastrointestinal AEs Through Week 24 in the Combined Safety Analysis Set (ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2)5 
PBO-Controlled
Active Comparator-Controlled
Crossover
ICO
N=632
PBO
N=237
Deucra
N=634
ICO
N=632
Deucra
N=634
PBO→ICO
N=215
Treatment period
W0-16
W0-24
W16-24
Mean weeks of follow-up
15.9
15.5
15.8
23.5
23.3
8.1
Gastrointestinal AE, n (%)
45 (7)
15 (6)
63 (10)
55 (9)
80 (13)
5 (2)
Abbreviations: AE, adverse event; Deucra, deucravacitinib; ICO, icotrokinra; PBO, placebo; W, week.
Note: The safety analysis set included all randomized and treated participants.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 4 January 2026.

 

References

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1 Bissonnette R, Soung J, Hebert AA, et al. Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393(18):1784-1795.  
2 Soung J, Cui Y, Bissonnette R, et al. Maintenance of response with icotrokinra, a targeted oral peptide, for the treatment of moderate-to-severe plaque psoriasis: randomized treatment withdrawal in adults (weeks 24-52) and continuous treatment in adolescents (through week 52) from the phase 3, ICONIC-LEAD trial. Oral Presentation presented at: European Academy of Dermatology and Venereology (EADV); September 17-20, 2025; Paris, France.  
3 Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12).  
4 Lain E, Warren RB, Gooderham M, et al. Durability of response to the targeted oral peptide icotrokinra for high-impact site psoriasis: 1-year ICONIC-TOTAL findings. Poster presented at: Fall Clinical Dermatology Conference; October 23-26, 2025; Las Vegas, NV.  
5 Stein Gold L, Armstrong AW, Bissonnette R, et al. Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomised, placebo-controlled and active-comparator-controlled trials. The Lancet. 2025;406(10510):1363-1374.  
6 Bissonnette R, Soung J, Hebert AA, et al. Supplement to: Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393:1784-1795.  
7 Gooderham M, Lain E, Bissonnette R, et al. Supplement to: Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12).