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icotrokinra

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Icotrokinra – Occurrence of Headaches 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 headaches across these studies.1-3 
    • The incidence rate of headaches reported in the icotrokinra group was 5% through week 24 in ICONIC-LEAD, 3% through week 16 in ICONIC-TOTAL, and 4% through week 24 in the ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 combined safety analysis.

CLINICAL DATA

ICONIC-LEAD

Bissonnette et al (2025)1 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 Headaches Through Week 24 in ICONIC-LEAD1 
PBO-Controlled
Active Treatment
ICO
N=456
PBO
N=228
ICO
N=456
PBO→ICOa
N=213
Treatment period
W0-16
W0-24
W16-24
Mean weeks of follow-up
15.9
15.8
23.6
8.2
Headache, n (%)
19 (4)
2 (<1)
21 (5)
0
Abbreviations: ICO, icotrokinra; PBO, placebo; W, week.
aThe data shown are for the period after participants transitioned from PBO to ICO at week 16 and continuing through week 24.

ICONIC-TOTAL

Gooderham 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 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 Headaches Through Week 16 in ICONIC-TOTAL2,4 
ICO
N=208
PBO
N=103
Mean weeks of follow-up
16.0
15.7
Headache, n (%)
6 (2.9)
6 (5.8)
Tension headache, n (%)
1 (0.5)
0
Abbreviations: ICO, icotrokinra; PBO, placebo.
  • One report of headache in the icotrokinra group led to discontinuation of trial drug.2 

ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2

Stein Gold et al (2025)3 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 Headaches Through Week 24 in the Combined Safety Analysis Set (ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2)3 
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
Headache, n (%)
26 (4)
11 (5)
19 (3)
28 (4)
20 (3)
3 (1)
Abbreviations: 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 13 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 Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12).  
3 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.  
4 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).