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icotrokinra

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Icotrokinra - Use in Pediatric Patients with Plaque Psoriasis

Last Updated: 02/10/2026

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
  • Icotrokinra use in adolescents is being studied in 3 plaque psoriasis (PsO) phase 3 clinical trials (ie, ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ASCEND).2-4
  • ICONIC-LEAD is an ongoing, phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled study with randomized withdrawal and retreatment (NCT06095115) evaluating the efficacy and safety of oral icotrokinra 200 mg daily in patients ≥12 years of age with moderate to severe plaque PsO.3
    • In a subgroup analysis of adolescents receiving icotrokinra, an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) at week 16 and week 24 was achieved by 84.1% and 86.4% of patients, respectively, and ≥90% reduction in Psoriasis Area and Severity Index from baseline (PASI 90) at week 16 and week 24 was achieved by 70.5% and 88.6% of patients, respectively.5 
    • At week 52, 82% of adolescents in the icotrokinra group and 91% of adolescents receiving PBO who were crossed over to receive icotrokinra at week 16 achieved an IGA 0/1 response. Similarly, 86% of adolescents in the icotrokinra group and 77% of adolescents receiving PBO who were crossed over to receive icotrokinra at week 16 achieved a PASI 90 response.6 
    • Through week 16, 50% and 73% of adolescents experienced any adverse event (AE) in the icotrokinra and PBO groups, respectively, with the most common AEs being upper respiratory tract infection and nasopharyngitis. The icotrokinra AE profile in adolescents through week 52 was consistent with that observed through week 16 and in the overall study population.5,6

CLINICAL DATA

ICONIC-LEAD: Overall Population

Bissonnette et al (2025)1,7 reported results through week 24 from ICONIC-LEAD, a phase 3, multicenter, randomized, double-blind, PBO-controlled clinical trial evaluating the efficacy and safety of oral icotrokinra 200 mg daily compared with PBO for the treatment of adults and adolescents (≥12 years of age) with moderate to severe plaque PsO.

Study Design/Methods

  • Key inclusion criteria1,3,5,7:
    • Age ≥12 years with moderate to severe plaque PsO diagnosed for ≥26 weeks at screening who were candidates for phototherapy or systemic therapy.
      • Total body surface area (BSA) involvement of ≥10%, PASI score ≥12, IGA score ≥3.
      • Body weight ≥40 kg (adolescents).
  • Adult and adolescent patients were randomized (2:1) to receive oral icotrokinra 200 mg daily or PBO daily, with PBO crossover to icotrokinra at week 16.
  • Coprimary endpoints: IGA 0/1 with a ≥2-grade improvement from baseline to week 16 and PASI 90 at week 16.

Results

Patient Characteristics
  • A total of 684 (icotrokinra, n=456; PBO, n=228) patients were included in the study, with 65% being male, 72% being white and a mean age of 42.6 years. Of those randomized, 66 (10%) were adolescents.1
Efficacy
  • Results for the coprimary endpoints at week 16 were as follows1:
    • IGA 0/1 was achieved by 65% of patients receiving icotrokinra compared to 8% of patients receiving PBO (P<0.001).
    • PASI 90 was achieved by 50% of patients receiving icotrokinra compared to 4% of patients receiving PBO (P<0.001).
Safety
  • Through week 16, 49% of patients receiving icotrokinra and 49% of patients receiving PBO reported ≥1 AE. The most common AEs were nasopharyngitis and upper respiratory tract infection.1

ICONIC-LEAD: Adolescent Subgroup

Bissonnette et al and Eichenfield et al (2025)1,5 reported top-line results through week 24 from a subgroup analysis of adolescents with moderate to severe plaque PsO.

Soung et al (2025)6 reported longer-term icotrokinra effects in adolescents through week 52.

Results

Patient Characteristics

Demographics and Baseline Clinical Characteristics in Adolescents5 
ICO
(n=44)
PBO
(n=22)
Demographics
   Age, years, mean (SD)
15.0 (1.8)
15.0 (1.5)
   Male, %
48
36
   Race, Asian/Black/White, %
23/4/70
23/0/77
   BMI, kg/m2, mean (SD)
26.0 (7.1)
24.4 (7.9)
Disease characteristics
   PsO disease duration, years, mean (SD)
4.9 (4.0)
5.8 (3.4)
   % BSA with PsO, mean (SD)
26.1 (15.6)
27.1 (14.0)
   IGA score of 3, moderate, %
70
82
   IGA score of 4, severe, %
30
18
   PASI (0-72), mean (SD)
19.8 (8.2)
18.6 (4.0)
Previous therapy, %
   Systemic therapya
52
50
   Biologic therapyb
14
41
   Phototherapy (PUVA or UVB)
23
14
Abbreviations: BMI, body mass index; BSA, body surface area; ICO, icotrokinra; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis; PUVA, psoralen plus ultraviolet A; SD, standard deviation; UVB, ultraviolet B.
aIncludes conventional nonbiologics, novel nonbiologics, 1,25-vitamin D3 and analogues, phototherapy, and biologics.
bIncludes adalimumab, alefacept, briakinumab, brodalumab, certolizumab pegol, efalizumab, etanercept, guselkumab, infliximab, ixekizumab, natalizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab.
Efficacy

Key Prespecified Endpoints in Adolescents1,5,6,8,9 
n (%)
ICO
(n=44)
PBO
(n=22)
PBO→ICO
Crossovera
(n=22)
IGA 0/1 and ≥2-grade improvement from baseline
   Week 16
37 (84)b,c
6 (27)
-
   Week 24
38 (86.4)
-
18 (81.8)
   Week 52
36 (81.8)
-
20 (90.9)
PASI 90
   Week 8
14 (32)
1 (5)
-
   Week 16
31 (70)b,d
3 (14)
-
   Week 24
39 (88.6)
-
11 (50)
   Week 52
38 (86.4)
-
17 (77.3)
IGA 0
   Week 16
18 (40.9)b,e
1 (4.5)
-
   Week 24
33 (75)
-
9 (40.9)
PASI 75
   Week 4
10 (23)
2 (9)
-
   Week 16
38 (86)b,f
5 (23)
-
   Week 24
40 (90.9)
-
17 (77.3)
   Week 52
42 (95.5)
-
20 (90.9)
PASI 100
   Week 16
13 (30)b,g
1 (5)
-
   Week 24
28 (63.6)
-
5 (22.7)
Abbreviations: CI, confidence interval; ICO, icotrokinra; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo.
aPBO→ICO group includes patients receiving PBO who were crossed over to receive ICO at week 16 through week 24.
bNominal P-values vs PBO (P<0.001 for IGA 0/1 and PASI 90, P<0.01 for IGA 0, and P<0.05 for PASI 100). These endpoints were not controlled for multiple comparisons. Therefore, the P-values are nominal, and statistical significance has not been established.
cIGA 0/1 at week 16: treatment difference of 56.2% (95% CI, 33.2-74.1).
dPASI 90 at week 16: treatment difference of 56.3% (95% CI, 32.5-73.0).
eIGA 0 at week 16: treatment difference of 35.7% (95% CI, 14.6-51.9).
fPASI 75 at week 16: treatment difference of 63.3% (95% CI, 39.7-79.7).
gPASI 100 at week 16: treatment difference of 24.4% (95% CI, 4.9-40.6).
Note: 95% CIs are based on a normal assumption without adjustment (Wald Method). P-values were derived from a Cochran-Mantel-Haenszel chi-square test stratified by geographic region.
Safety
  • The icotrokinra AE profile through week 52 in adolescents was consistent with that observed in the overall study population.6 
    • Through week 24, no safety signals were identified, and no deaths, active tuberculosis, or malignancies were reported in the icotrokinra group.5 
    • For AE information through week 16, see Table: AEs in Adolescents through Week 16.5 

AEs in Adolescents through Week 165
ICO
(n=44)
PBO
(n=22)
Mean weeks of follow-up
16.2
16.2
Any AE, n (%)
22 (50)
16 (73)
Infection, n (%)
14 (32)
6 (27)
   Upper respiratory tract infection
6 (14)
1 (4)
   Nasopharyngitis
5 (11)
3 (14)
SAE, n (%)
2 (4)a,b
0
Abbreviations: AE, adverse event; CT, computed tomography; ICO, icotrokinra; PBO, placebo; SAE, serious adverse event.
aSeventeen-year-old female with a medical history of obesity and a gastric sleeve procedure leading to rapid weight loss before study entry underwent CT and ultrasound, which showed pancreatitis due to choledocholithiasis. Cholecystectomy was performed, and she was discharged in good condition. Treatment was interrupted but resumed after resolution, and she has continued with the study.
bSeventeen year-old female with a medical history of joint pain was admitted to the hospital at week 4 of the study for further diagnostic evaluation of joint pain. No imaging studies were completed. Treatment was continued without interruption. She was discharged the next day in good condition. No diagnosis was confirmed.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 05 December 2025.

References

Show
1 Bissonnette R, Soung J, Hebert AA, et al. Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393:1784-1795.  
2 Janssen Research & Development, LLC. A study of JNJ-77242113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/​or palms of the hands and the soles of the feet) (ICONIC-TOTAL). ln: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 December 08]. Available from: https://clinicaltrials.gov/study/NCT06095102 NLM Identifier: NCT06095102.  
3 Janssen Research & Development, LLC. A study of JNJ-77242113 in adolescent and adult participants with moderate to severe plaque psoriasis (ICONIC-LEAD). ln: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 December 08]. Available from: https://clinicaltrials.gov/study/NCT06095115 NLM Identifier: NCT06095115.  
4 Janssen Research & Development, LLC. A study to assess efficacy and safety of JNJ-77242113 compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis (ICONIC-ASCEND). ln: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 December 05]. Available from: https://clinicaltrials.gov/study/NCT06934226 NLM Identifier: NCT06934226.  
5 Eichenfield L, Galimberti R, Hebert A, et al. Icotrokinra, a novel targeted oral peptide (IL-23R-inhibitor), in adolescents with moderate-to-severe plaque psoriasis: results of subgroup analyses from a phase 3, randomized, double-blind, placebo-controlled study (ICONIC-LEAD). Oral Presentation presented at: World Congress of Pediatric Dermatology; April 8-11, 2025; Buenos Aires, Argentina.  
6 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.  
7 Bissonnette R, Soung J, Adelaide H, et al. Icotrokinra, a targeted oral peptide that selectively blocks the interleukin-23-receptor, for the treatment of moderate-to-severe plaque psoriasis: results through week 24 of the phase 3, randomized, double-blind, placebo-controlled ICONIC-LEAD trial. Oral Presentation presented at: American Academy of Dermatology; March 7-11, 2025; Orlando, FL.  
8 Data on File. Icotrokinra. Clinical Study Report 77242113PSO3001. Janssen Research & Development, LLC. EDMS-RIM-1306643; 2025.  
9 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.