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ICOTYDE™

(icotrokinra)

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ICOTYDE™ (icotrokinra)
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ICOTYDE - Use in Pediatric Patients with Plaque Psoriasis

Last Updated: 04/22/2026

SUMMARY

  • The company cannot recommend any practices, procedures, or usage of ICOTYDE that deviate from the approved labeling.
  • ICOTYDE use in adolescents is being studied in 3 plaque psoriasis (PsO) phase 3 clinical trials (ie, ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ASCEND).1-3
  • 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 ICOTYDE 200 mg daily in patients ≥12 years of age with moderate to severe plaque PsO.2
    • In a subgroup analysis of adolescents receiving ICOTYDE, 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.4
    • At week 52, 82% of adolescents in the ICOTYDE group and 91% of adolescents receiving PBO who were crossed over to receive ICOTYDE at week 16 achieved an IGA 0/1 response. Similarly, 86% of adolescents in the ICOTYDE group and 77% of adolescents receiving PBO who were crossed over to receive ICOTYDE at week 16 achieved a PASI 90 response.5,6
    • At week 52, a Psoriasis Symptoms and Signs Diary (PSSD) symptom score of 0 was achieved by 59% of adolescents in the ICOTYDE group and 73% of adolescents who received PBO and crossed over to ICOTYDE at week 16. Similarly, a PSSD sign score of 0 was achieved by 41% and 50% of adolescents in the respective groups.7 
    • Through week 16, 50% and 73% of adolescents experienced any adverse event (AE) in the ICOTYDE and PBO groups, respectively. The AE profile of ICOTYDE in adolescents was comparable to PBO through week 16 and remained consistent from week 16 to week 52.4-6

CLINICAL DATA

ICONIC-LEAD: Adolescent Subgroup

ICONIC-LEAD is a phase 3, multicenter, randomized, double-blind, PBO-controlled clinical trial evaluating the efficacy and safety of oral ICOTYDE for the treatment of adults and adolescents (≥12 years of age) with moderate to severe plaque PsO.2

Bissonnette et al and Eichenfield et al (2025)4,8 reported top-line results through week 24 from a subgroup analysis of adolescents with moderate to severe plaque PsO.

Soung et al (2025, 2026)5-7 assessed longer-term ICOTYDE effects on efficacy, safety, patient-reported outcomes (PROs), and health-related quality of life (HRQoL) measures in adolescents with moderate to severe plaque PsO through week 52.

Study Design/Methods

  • Key, relevant inclusion criteria6,7:
    • Aged 12 to <18 years
    • Plaque PsO for ≥26 weeks
    • Body surface area (BSA) ≥10%, Psoriasis Area and Severity Index (PASI) score ≥12, Investigator’s Global Assessment (IGA) score ≥3
    • Candidate for phototherapy or systemic therapy for plaque PsO
    • Body weight ≥40 kg
  • Adolescent patients were randomized (2:1) to receive oral ICOTYDE 200 mg once daily or PBO, with PBO crossover to ICOTYDE at week 16.
  • Outcome measures of ICOTYDE in adolescent patients through week 52 are presented in Table: Outcomes in the Adolescent Subgroup through Week 52. 

Outcomes in the Adolescent Subgroup through Week 526
Efficacy and Safety Outcomes 
IGA 0/1 and ≥2-grade improvement from baseline, IGA 0 
PASI 75/90/100 
IGA 0/1 at week 52 among week-24 IGA 0/1 responders 
PASI 90 at week 52 among week-24 PASI 90 responders 
Percentage of patients with AEs and exposure-adjusted incidence rates (per 100 PY) 
PROs and HRQoL Outcomes 
CMI in PSSD Itch score (≥4-point improvement from baseline) 
PSSD Symptom score 0 
PSSD Sign score 0 
CDLQI score 0/1 
Abbreviations: AE, adverse event; CDLQI, Children's Dermatology Life Quality Index; CMI, clinically meaningful improvement; HRQoL, health-related quality of life; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PRO, patient-reported outcome; PSSD, Psoriasis Symptoms and Signs Diary; PY, patient years. 

Results

Patient Characteristics

Demographics and Baseline Clinical Characteristics in Adolescents4,6,7
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, %
23/5/70
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
PROs
   CDLQI score (0-30), mean (SD)c
6.8 (5.6)
6.5 (4.6)
      CDLQI score >1, %
93
86
   PSSD symptom score (0-100), mean (SD)d
35.4 (26.6)
29.9 (12.4)
      PSSD symptom score >0, %
100
100
      PSSD itch score ≥4, %
73
85
   PSSD sign score (0-100), mean (SD)d
46.2 (26.0)
46.7 (17.8)
      PSSD sign score >0, %
100
100
Abbreviations: BMI, body mass index; BSA, body surface area; CDLQI, Children's Dermatology Life Quality Index; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PRO, patient-reported outcome; PsO, psoriasis; PSSD, Psoriasis Symptoms and Signs Diary; PUVA, psoralen plus ultraviolet A; SD, standard deviation; UVB, ultraviolet B.
aIncluding conventional and novel nonbiologics, 1,25-vitamin D3 and analogs, phototherapy, and biologics.
bIncluding adalimumab, alefacept, briakinumab, brodalumab, certolizumab pegol, efalizumab, etanercept, guselkumab, infliximab, ixekizumab, natalizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab.
cAdolescents with nonmissing CDLQI scores at baseline: ICO, n=43; PBO, n=22.
dAdolescents with nonmissing PSSD symptom/sign scores at baseline: ICO, n=37; PBO, n=20.
Efficacy

Key Prespecified Endpoints in Adolescents through Week 524,5,8-10
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)
-
18 (82)
   Week 52
36 (82)
-
20 (91)
PASI 90
   Week 8
14 (32)
1 (5)
-
   Week 16
31 (70)b,d
3 (14)
-
   Week 24
39 (89)
-
11 (50)
   Week 52
38 (86)
-
17 (77)
IGA 0
   Week 16
18 (41)b,e
1 (5)
-
   Week 24
33 (75)
-
9 (41)
   Week 52
27 (61)
-
14 (64)
PASI 75
   Week 4
10 (23)
2 (9)
-
   Week 16
38 (86)b,f
5 (23)
-
   Week 24
40 (91)
-
17 (77)
   Week 52
42 (96)
-
20 (91)
PASI 100
   Week 16
13 (30)b,g
1 (5)
-
   Week 24
28 (64)
-
5 (23)
   Week 52
25 (57)
-
11 (50)
Abbreviations: CI, confidence interval; ICO, ICOTYDE; 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.
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.
  • Among ICOTYDE-randomized adolescents, 89% of those who achieved IGA 0/1 at week 24 and 92% of those who achieved PASI 90 at week 24 maintained the response at week 52.6 
  • Other endpoints at week 52 are presented in Table: PROs and HRQoL Measures through Week 52.

PROs and HRQoL Measures through Week 526,7
Endpoints, %
ICO
PBO
PBO→ICO
Crossover
CMI in PSSD Itch scorea
(n=27)
(n=17)
(n=17)
   Week 4
22
0
-
   Week 16
56b
12
-
   Week 24
93
-
59
   Week 52
81
-
82
PSSD Symptom score 0a
(n=37/32)c
(n=20)
(n=15)
   Week 8
14
0
-
   Week 16
35b
0
-
   Week 24
56
-
33
   Week 52
59
-
73
PSSD Sign score 0a
(n=37)
(n=20)
(n=20)
   Week 8
14
0
-
   Week 16
27d
0
-
   Week 24
41
-
20
   Week 52
41
-
50
CDLQI 0/1a
(n=40)
(n=19)
(n=19)
   Week 16
68e
11
-
   Week 24
82
-
63
   Week 52
85
-
74
Abbreviations: CDLQI, Children's Dermatology Life Quality Index; CMI, clinically meaningful improvement; HRQoL, health-related quality of life; ICO, ICOTYDE; PBO, placebo; PRO, patient-reported outcome;
PSSD, Psoriasis Symptoms and Signs Diary.
aAmong adolescents with a baseline PSSD Itch score ≥4, PSSD Symptom score >0, PSSD Sign score >0, and CDLQI score >1, respectively.
bNominal P<0.01 for ICO vs PBO. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
cData affected by a translation error in the German 7-day recall version of the PSSD after week 16 were excluded.
dNominal P=0.01 for ICO vs PBO. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
eNominal P<0.001 for ICO vs PBO. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
Safety
  • The ICOTYDE AE profile through week 52 in adolescents was consistent with that observed in the overall study population.5
    • Through week 24, no safety signals were identified, and no deaths, active tuberculosis, or malignancies were reported in the ICOTYDE group.4
    • For AE information through week 52, see Table: AEs in Adolescents through Week 52.4,6

AEs in Adolescents through Week 524,6
PBO-Controlled (Through Week 16)
Through
Week 52
ICO
(n=44)
PBO
(n=22)
ICO Combined (N=66)a
Mean weeks/total PY of follow-up
16.2/13.7
16.2/6.8
46.3/58.6
Any AE, n (%)
22 (50)
16 (73)
46 (70)
   Incidence/100 PY (95% CI)b,c
238 (139-338)
521 (266-776)
164 (117-212)
Infection, n (%)
14 (32)
6 (27)
31 (47)
   Incidence/100 PY (95% CI)b,c
130 (62-198)
116 (23-209)
78 (50-105)
SAE, n (%)
2 (5)
0
4 (6)
   Incidence/100 PY (95% CI)b,d
15 (2-54)
0 (0-44)
7 (2-18)
AE leading to discontinuation, n
0
0
0
   Incidence/100 PY (95% CI)b,d
0 (0-22)
0 (0-44)
0 (0-5)
Gastrointestinal AE, n (%)
2 (5)
1 (5)
5 (8)
   Incidence/100 PY (95% CI)b,d
15 (2-53)
15 (<1-85)
9 (3-21)
Malignancy, n
0
0
0
   Incidence/100 PY (95% CI)b,d
0 (0-22)
0 (0-44)
0 (0-5)
Abbreviations: AE, adverse event; CI, confidence interval; ICO, ICOTYDE; PBO, placebo; PY, patient year; SAE, serious adverse event.
Note: Safety analysis set included all randomized and treated patients.
aIncludes patients who received ICO through week 52 and data after week 16 for patients initially on PBO who switched to ICO.
bIncidence/100 PY: (number of patients with AEs/total PY at risk) × 100
cCls were calculated using a Wald statistic with the normal assumption
dCIs were calculated based on an exact method assuming that the observed number of events follows a Poisson distribution.

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 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 2026 March 13]. Available from: https://clinicaltrials.gov/study/NCT06095102 NLM Identifier: NCT06095102.  
2 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 2026 April 13]. Available from: https://clinicaltrials.gov/study/NCT06095115 NLM Identifier: NCT06095115.  
3 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 2026 April 13]. Available from: https://clinicaltrials.gov/study/NCT06934226 NLM Identifier: NCT06934226.  
4 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.  
5 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.  
6 Soung J, Lebwohl MG, Hebert A, et al. Durability of icotrokinra (targeted oral peptide) effects in adolescents with moderate-to-severe plaque psoriasis: one-year results from the ICONIC-LEAD study. Posters presented at: AAD Annual Meeting; March 27-31, 2026; Denver, Colorado, USA.  
7 Soung J, Lebwohl MG, Hebert A, et al. Early and durable improvements in patient-reported outcomes with the targeted oral peptide icotrokinra in adolescents with moderate-to-severe plaque psoriasis: one-year results from the ICONIC-LEAD study. Poster presented at: AAD Annual Meeting; March 27-31, 2026; Denver, Colorado, USA.  
8 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.  
9 Data on File. Icotrokinra. Clinical Study Report 77242113PSO3001. Janssen Research & Development, LLC. EDMS-RIM-1306643; 2025.  
10 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(18):1784-1795.