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icotrokinra

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Icotrokinra – Overview of ICONIC-LEAD Clinical Trial

Last Updated: 09/26/2025

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 is being studied in five plaque psoriasis (PsO) phase 3 clinical trials (ICONIC-LEAD, ICONIC-TOTAL, ICONIC ADVANCE-1, ICONIC ADVANCE-2, ICONIC-ASCEND).2-6
  • ICONIC-LEAD is an ongoing, phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled study (NCT06095115) evaluating the efficacy and safety of icotrokinra 200 mg daily in patients ≥12 years of age with moderate to severe plaque PsO.4
    • At week 16, the co-primary endpoints for Investigator’s Global Assessment (IGA) score of 0/1 and ≥2-grade improvement from baseline were achieved by 65% of patients receiving icotrokinra compared to 8% of patients receiving PBO (P<0.001) and Psoriasis Area and Severity Index (PASI) 90 was achieved by 50% of patients receiving icotrokinra compared to 4% of patients receiving PBO (P<0.001).1 
    • At week 24, the prespecified endpoints for IGA 0/1 was achieved by 74% of patients receiving icotrokinra and PASI 90 was achieved by 65% of patients receiving icotrokinra.1 
    • In the high-impact site PsO subgroup analysis at week 16 and week 24, patients receiving icotrokinra showed improvements in the following7:
      • For scalp involvement, Scalp-specific Investigator’s Global Assessment (ss-IGA) 0/1 was achieved by 72% and 81% of patients, and ss-IGA 0 by 53% and 65% of patients, respectively.
      • For genital involvement, Static Physician’s Global Assessment of Genitalia (sPGA-G) 0/1 was achieved by 71% and 80% of patients, and sPGA-G 0 by 58% and 70% of patients, respectively.
      • For hand and foot involvement, hand/foot Physician’s Global Assessment (hf-PGA) 0/1 was achieved by 74% and 76% of patients, and hf-PGA 0 by 59% and 62% of patients, respectively.
      • For nails, fingernail Physician’s Global Assessment (f-PGA) 0/1 was achieved by 50% and 64% of patients, and f-PGA 0 by 24% and 29% of patients, respectively. A least-squares (LS) mean improvement in modified Nail Psoriasis Severity Index (mNAPSI) from baseline was observed in 44% of patients at week 16.
    • In the adolescent subgroup analysis, the prespecified endpoint of IGA 0/1 at week 16 and week 24 was achieved by 84.1% and 86.4% of patients receiving icotrokinra, respectively, and the prespecified endpoint of PASI 90 at week 16 and week 24 was achieved by 70.5% and 88.6% of patients receiving icotrokinra, respectively.8
    • Through week 16, 49% of patients receiving icotrokinra and 49% of patients receiving PBO reported ≥1 adverse event (AE). AEs were generally similar between groups.1
    • Through week 24, the most common AEs were similar to those observed through week 16. No new safety signals were identified through week 24.1

CLINICAL DATA

ICONIC-LEAD

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

Study Design/Methods

  • Key inclusion criteria are as follows1,4,8:
    • Adult and adolescents (12-17 years of age) with a diagnosis of plaque PsO for ≥26 weeks (with or without psoriatic arthritis [PsA]) and who were candidates for phototherapy or systemic therapy
    • Total body surface area (BSA) ≥10%, PASI ≥12, and IGA ≥3 at screening and baseline
    • Body weight ≥40 kilograms (adolescents)
  • Key exclusion criteria are as follows4:
    • Nonplaque form of PsO (eg, erythrodermic, guttate, or pustular)
    • Drug-induced PsO
    • Severe, progressive or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disease
  • Adult and adolescent patients were randomized in a 2:1 ratio to receive icotrokinra 200 mg oral (PO) daily or PBO daily with PBO crossover to icotrokinra at week 16, as shown in Figure: ICONIC-LEAD Study Design.1

ICONIC-LEAD Study Design1

Abbreviations: ICO, icotrokinra; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; R, randomized; QD, daily; WK, week.


ICONIC-LEAD Key Clinical Trial Outcome Measures1,4
Coprimary Endpoints
Time Frame
Percentage of patients who achieved an IGA score of cleared (0) or minimal (1) and ≥2-grade improvement from baseline
Week 16
Percentage of patients who achieved PASI 90 response
Week 16
Key Secondary Endpoints
Percentage of patients who achieved IGA score of cleared (0)
Week 16
Percentage of patients who achieved PASI 75 response
Weeks 4 and 16
Percentage of patients who achieved PASI 90 response
Week 8
Percentage of patients who achieved PASI 100 response
Week 16
Percentage of patients who achieved ss-IGA score of absence of disease (0) or very mild disease (1) and had a ≥2-grade improvement from baseline
Week 16
Percentage of patients who achieved PSSD symptom score of 0
Weeks 8 and 16
Percentage of patients with ≥4-point improvement from baseline in PSSD itch score
Weeks 4 and 16
Note: Additional details regarding study outcome definitions can be found on clinicaltrials.gov.
Abbreviations: IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PSSD, Psoriasis Symptoms and Signs Diary; ss-IGA, scalp-specific Investigator’s Global Assessment.

Results

Patient Characteristics

Baseline Demographics and Clinical Characteristics1,7
Icotrokinra 200 mg QD
(n=456)
Placebo
(n=228)
Demographics
Age, years, mean (SD)
42.4 (16.3)
43.2 (16.6)
   Adolescent cohort, years, mean (SD)
15 (1.8)
15 (1.5)
Male, %
64
68
White, %
72
72
BMI, kg/m2, mean (SD)a
29.2 (6.9)
29.3 (7)
Disease Characteristics
PsO disease duration, years, mean (SD)
17.3 (13.9)
16.6 (12.7)
% BSA with PsO, mean (SD)
24.6 (14.3)
27.1 (16.2)
IGA score, moderate (3), %
75
76
IGA score, severe (4), %
25
24
PASI (0-72), mean (SD)
19.4 (7.1)
20.8 (8.1)
PsO involving the scalp
ss-IGA score, moderate (3)b, %
59
51
ss-IGA score, severe (4)b, %
17
22
Previous Therapy, %
Phototherapy (PUVA and UVB)
30
29
Systemic therapyc
72
71
Biologic therapyd
32
37
High Impact Sites
ss-IGA score ≥3, %
75
72
sPGA-G score ≥3, %
20
19
hf-PGA score ≥3, %
23
21
f-PGA score ≥2, %
30
29
mNAPSI score >0, %
43
44
   mNAPSI score, mean
17.7
19.1
Abbreviations: BMI, body mass index; BSA, body surface area; f-PGA, fingernail Physician’s Global Assessment; hf-PGA, hand/foot Physician’s Global Assessment; IGA, Investigator’s Global Assessment; mNAPSI, modified Nail Psoriasis Severity Index; PASI, Psoriasis Area Severity Index; PsO, psoriasis; PUVA, psoralen plus ultraviolet A; QD, daily; SD, standard deviation; sPGA-G, Static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global Assessment; UVB, ultraviolet B.
aIcotrokinra: n=455; Placebo: n=227.
bIcotrokinra: n=451; Placebo: n=227.
cIncludes conventional nonbiologic systemics, novel nonbiologic systemics, 1,25-vitamin D3 and analogues, phototherapy, biologics.
dIncludes adalimumab, alefacept, briakinumab, brodalumab, certolizumab pegol, efalizumab, etanercept, guselkumab, infliximab, ixekizumab, natalizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab
Efficacy

Coprimary, Key Secondary, and Other Prespecified Endpoints1,9 

Icotrokinra 200 mg QD
n (%)
Placebo
n (%)
Placebo→Icotrokinra Crossovera
n (%)
n=456
n=228
n=213
Proportion of patients achieving:
IGA 0/1 and ≥2-grade improvement from baseline
Week 16
295 (64.7); P<0.001b
19 (8.3)
-
Week 24
338 (74.1)
-
135 (63.4)
PASI 90
Week 8
98 (21.5); P<0.001c
3 (1.3)
-
Week 16
226 (49.6); P<0.001d
10 (4.4)
-
Week 24
296 (64.9)
-
87 (40.8)
PASI 75
Week 4
68 (14.9); P<0.01e
5 (2.2)
-
Week 16
315 (69.1); P<0.001e
25 (11.0)
-
Week 24
368 (80.7)
-
149 (70.0)
IGA 0
Week 16
152 (33.3); P<0.001e
3(1.3)
-
Week 24
211 (46.3)
-
49 (23.0)
PASI 100
Week 16
123 (27.0); P<0.001e
1 (0.4)
-
Week 24
184 (40.4)
-
29 (13.6)
PSSD symptom score of 0f
n=408
n=208
n=194
Week 8
29 (7.1); P<0.01
3 (1.4)
-
Week 16
82 (20.1); P<0.001g
2 (1.0)
-
Week 24
153 (37.5)
-
43 (22.2)
≥4 point improvement in PSSD itch score from baselinef
n=350
n=176
n=166
Week 4
67 (19.1); P<0.01g
9 (5.1)
-
Week 16
203 (58.0); P<0.001g
23 (13.1)
-
Week 24
255 (72.9)
-
116 (69.9)
ss-IGA 0/1 and ≥2-grade improvement from baselineh
n=405
n=200
n=186
Week 16
293 (72.3); P<0.001e
30 (15.0)
-
Week 24
326 (80.5)
-
143 (76.9)
Abbreviations: IGA, Investigator’s Global Assessment; PASI, Psoriasis Area Severity Index; PASI 75/90/100, reduction from baseline 75%/90%/100% in the PASI score; PSSD, Psoriasis Symptom and Sign Diary; QD, daily; ss-IGA, scalp-specific Investigator’s Global Assessment.
aPatients crossed over from placebo to icotrokinra at week 16.
bCoprimary endpoint; Treatment difference of 56.4% (95% CI, 50.4-61.7); P values were calculated based on Cochran-Mantel-Haenszel chi-square test stratified by age group, baseline weight category (adults only), and geographic region.
cP values were calculated based on Cochran-Mantel-Haenszel chi-square test stratified by age group, baseline weight category (adults only), and geographic region, if applicable.
dCoprimary endpoint; Treatment difference of 45.1% (95% CI, 39.5-50.4); P values were calculated based on Cochran-Mantel-Haenszel chi-square test stratified by age group, baseline weight category (adults only), and geographic region.
eP values were calculated based on Cochran-Mantel-Haenszel chi-square test stratified by age group, baseline weight category (adults only), and geographic region.
fAmong patients with baseline PSSD itch ≥4 or PSSD symptom score >0.
gP values were calculated based on Cochran-Mantel-Haenszel chi-square test stratified by age group, baseline weight category (adults only), and geographic region, if applicable. Fisher’s exact test was used for PSSD symptom 0 at week 8.
hAmong patients with baseline ss-IGA score ≥2.

Soung et al (2025)7  conducted subgroup analyses to evaluate the effect of icotrokinra in patients with plaque PsO and high-impact site (scalp, genitals, hands/feet, nails) involvement through week 24.

Results


High-impact Site Response Rates7,9
% (n/N)
Icotrokinra 200 mg QD
Placebo
Proportion of patients achieving:
ss-IGA 0/1a
Week 16
72.4 (249/344)
13.9 (23/165)b,c
Week 24
80.8 (278/344)
-
ss-IGA 0a
Week 16
52.9 (182/344)
9.1 (15/165)c,d
Week 24
65.1 (224/344)
-
sPGA-G 0/1e
Week 16
70.7 (65/92)
38.6 (17/44)c,f
Week 24
80.4 (74/92)
-
sPGA-G 0e
Week 16
57.6 (53/92)
25.0 (11/44)c,g
Week 24
69.6 (64/92)
-
hf-PGA 0/1h
Week 16
74.0 (77/104)
23.4 (11/47)c,i
Week 24
76 (79/104)
-
hf-PGA 0h
Week 16
58.7 (61/104)
17.0 (8/47)c,j
Week 24
62.5 (65/104)
-
f-PGA 0/1k
Week 16
50.4 (69/137)
21.2 (14/66)c,l
Week 24
63.5 (87/137)
-
f-PGA 0k
Week 16
24.1 (33/137)
12.1 (8/66)m,n
Week 24
29.2 (40/137)
-
mNAPSI, LS mean (95% CI) improvement from baselineo
N=187
N=98
Week 16
-43.5 (22.99-63.99)
-2.2 (23.29-27.76)p,q
Abbreviations: CI, confidence interval; CMH, Cochran-Mantel-Haenszel; f-PGA, fingernail Physician’s Global Assessment; hf-PGA, hand/foot Physician’s Global Assessment; ICE, intercurrent event; LS, least squares; MMRM, Mixed-Effects Model for Repeated Measures; mNAPSI, modified Nail Psoriasis Severity Index; sPGA-G, Static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global Assessment; QD, daily.
aAmong patients with a baseline ss-IGA score ≥3.
bTreatment difference of 58.4% (95% CI, 50.8-64.8); Treatment difference and 95% CI (using Miettinen-Nurminen method) were calculated adjusting for age group, baseline weight category for adults, and geographic region using Mantel-Haenszel weights. P-values were based on CMH chi-square test stratified by age group, baseline weight category for adults, and geographic region.
cNominal P-value <0.001 for icotrokinra vs placebo. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
dTreatment difference of 43.6% (95% CI, 36.5-50.1); Treatment difference and 95% CI (using Miettinen-Nurminen method) were calculated adjusting for age group, baseline weight category for adults, and geographic region using Mantel-Haenszel weights. P-values were based on CMH chi-square test stratified by age group, baseline weight category for adults, and geographic region.
eAmong patients with a baseline sPGA-G score ≥3.
fTreatment difference of 33.8% (95% CI, 15.7-49.6); Treatment difference and 95% CI (using Miettinen-Nurminen method) were calculated adjusting for age group and baseline weight category for adults using Mantel-Haenszel weights. P-values were based on CMH chi-square test stratified by age group and baseline weight category for adults.
gTreatment difference of 34.4% (95% CI, 16.6-49.3); Treatment difference and 95% CI (using Miettinen-Nurminen method) were calculated adjusting for age group and baseline weight category for adults using Mantel-Haenszel weights. P-values were based on CMH chi-square test stratified by age group and baseline weight category for adults.
hAmong patients with a baseline hf-PGA score ≥3.
iTreatment difference of 50.6% (95% CI, 34.2-63.6); Treatment difference and 95% CI (using Miettinen-Nurminen method) were calculated adjusting for age group and baseline weight category for adults using Mantel-Haenszel weights. P-values were based on CMH chi-square test stratified by age group and baseline weight category for adults.
jTreatment difference of 42.0% (95% CI, 25.9-54.8); Treatment difference and 95% CI (using Miettinen-Nurminen method) were calculated adjusting for age group and baseline weight category for adults using Mantel-Haenszel weights. P-values were based on CMH chi-square test stratified by age group and baseline weight category for adults.
kAmong patients with a baseline f-PGA score ≥2.
lTreatment difference of 30.1% (95% CI, 16.4-42.0); Treatment difference and 95% CI (using Miettinen-Nurminen method) were calculated adjusting for age group and baseline weight category for adults using Mantel-Haenszel weights. P-values were based on CMH chi-square test stratified by age group and baseline weight category for adults.
mTreatment difference of 11.9% (95% CI, 0.2-22.0); Treatment difference and 95% CI (using Miettinen-Nurminen method) were calculated adjusting for age group and baseline weight category for adults using Mantel-Haenszel weights. P-values were based on CMH chi-square test stratified by age group and baseline weight category for adults.
nNominal P-value <0.05 for icotrokinra vs placebo. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
oAmong patients with a baseline mNAPSI score >0. LS Means and LS Mean differences, and P-value were based on the MMRM model with treatment group, visit, treatment group by visit interaction, age group, baseline weight, geographic region, baseline mNAPSI total score, and baseline mNAPSI total score by visit interaction.
pTreatment difference of 41.3% (95% CI, 12.8-69.7); Treatment difference and 95%  as covariates. CI (using Miettinen-Nurminen method) were calculated adjusting for age group and baseline weight category for adults using Mantel-Haenszel weights. P-values were based on CMH chi-square test stratified by age group and baseline weight category for adults.
qNominal P-value <0.01 for icotrokinra vs placebo. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.

Adolescents (12-17 years of age)

Eichenfield et al (2025)8presented top line results through week 24 from a subgroup analysis of adolescent patients with moderate-to-severe plaque PsO.

Results

Patient Characteristics

Baseline Demographics and Clinical Characteristics in Adolescents8 
Icotrokinra 200 mg QD
(n=44)
Placebo
(n=22)
Demographics
Age, years, mean (SD)
15.0 (1.8)
15.0 (1.5)
Female, %
52
64
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, moderate (3), %
70
82
IGA score, severe (4), %
30
18
PASI (0-72), mean (SD)
19.8 (8.2)
18.6 (4.0)
Previous Therapy, %
Phototherapy (PUVA and UVB)
23
14
Systemic therapya
52
50
Biologic therapyb
14
41
Abbreviations: BMI, body mass index; BSA, body surface area; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area Severity Index; PsO, psoriasis; PUVA, psoralen plus ultraviolet A; QD, daily; SD, standard deviation; UVB, ultraviolet B.
aIncludes conventional nonbiologic, novel nonbiologic, 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 Adolescents8,9 
Icotrokinra 200 mg QD
n (%)
Placebo
n (%)
Placebo→Icotrokinra Crossover
n (%)
n=44
n=22
n=22
Proportion of patients achieving:
IGA 0/1 and ≥2-grade improvement from baseline
Week 16
37 (84.1)a
6 (27.3)
-
Week 24
38 (86.4)
-
18 (81.8)
PASI 90
Week 16
31 (70.5)b
3 (13.6)
-
Week 24
39 (88.6)
-
11 (50.0)
IGA 0
Week 16
18 (40.9)c
1 (4.5)
-
Week 24
33 (75.0)
-
9 (40.9)
PASI 100
Week 16
13 (29.5)d
1 (4.5)
-
Week 24
28 (63.6)
-
5 (22.7)
Abbreviations: CI, confidence interval; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area Severity Index; QD, daily.
aNominal P-value <0.001 for icotrokinra vs placebo. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established; IGA 0/1 at week 16: Treatment Difference of 56.2% (CI, 33.2-74.1); 95% CI are based on the normal assumption without adjustment (Wald Method). P-value derived from Cochran-Mantel-Haenszel chi-square test stratified by geographic region.
bNominal P-value <0.001 for icotrokinra vs placebo. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established; PASI 90 at week 16: Treatment Difference of 56.3% (CI, 32.5-73.0); 95% CI are based on the normal assumption without adjustment (Wald Method). P-value derived from Cochran-Mantel-Haenszel chi-square test stratified by geographic region.
cNominal P-value <0.001 for icotrokinra vs placebo. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established;IGA 0 at week 16: Treatment Difference of 35.7% (CI, 14.6-51.9); 95% CI are based on the normal assumption without adjustment (Wald Method). P-value derived from Cochran-Mantel-Haenszel chi-square test stratified by geographic region.
dNominal P-value <0.05 for icotrokinra vs placebo. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established; PASI 100 at week 16: Treatment Difference of 24.4% (CI, 4.9-40.6); 95% CI are based on the normal assumption without adjustment (Wald Method). P-value derived from Cochran-Mantel-Haenszel chi-square test stratified by geographic region.

Safety

  • Through week 16, 49% (225/456) of patients receiving icotrokinra and 49% (112/228) of patients receiving PBO reported ≥1 AE (see Table: Adverse Events in the Overall Study Population through Week 16).1 
  • Through week 24, the most common AEs were similar to those observed through week 16. No safety signals were identified through week 24.1 

Adverse Events in the Overall Study Population through Week 161 
Icotrokinra 200 mg QD
(n=456)
Placebo
(n=228)
Mean weeks of follow-up
15.9
15.8
Any AE
225 (49%)
112 (49%)
Most common AEs (≥5%)
   Nasopharyngitis
31 (7%)
15 (7%)
   Upper respiratory tract infection
30 (7%)
16 (7%)
SAEa
6 (1%)
6 (3%)
Infection
107 (23%)
51 (22%)
   Serious Infection
1 (<1%)
0
AE leading to discontinuationb
6 (1%)
1 (<1%)
Gastrointestinal AE
26 (6%)
13 (6%)
Active tuberculosis
0
0
Malignancyc
2 (<1%)
0
Abbreviations: AE, adverse events; QD, daily; SAEs, serious adverse events.
aSAEs through week 16 included acute cholecystitis, concussion, craniofacial fracture, pelvic fracture, psoriasis, and hypertensive urgency in the placebo group; and adenocarcinoma of the colon, prostate cancer, pancreatitis, bacterial gastroenteritis (serious infection), arthralgia, and subarachnoid hemorrhage in the icotrokinra group.
bAEs leading to discontinuation through week 16 included blood glucose increased in the placebo group; and adenocarcinoma of the colon, prostate cancer, hypertriglyceridemia, subarachnoid hemorrhage, erectile dysfunction, and psoriasis in the icotrokinra group.
cMalignancies reported were adenocarcinoma of the colon (n=1 in a patient who had a history of smoking; the patient reported mild gastroenteritis during screening, and severe colitis starting on study day 7, and severe ileus on day 14 leading up to the diagnosis of grade 3 adenocarcinoma of the colon on day 19) and prostate cancer (n=1 in a patient who had a history smoking and a family history of prostate cancer; grade 1 prostate cancer was diagnosed on study day 48)
  • Through week 16, in the adolescent sub group analysis, the rates of clinical laboratory abnormalities were similar between the icotrokinra group and PBO group and remained low through week 24.8 
  • Through week 24, in the adolescent subgroup analysis, the most common AEs were similar to those observed through week 16. No safety signals were identified through week 24 (see Table: Adverse Events through Week 16 in Adolescents).8 
  • Through week 24, no death, malignancies or active tuberculosis were reported in the icotrokinra group.8 

Adverse Events through Week 16 in Adolescents8
Icotrokinra 200 mg QD
(n=44)
Placebo
(n=22)
Mean weeks of follow-up
16.2
16.2
Any AE
22 (50%)
16 (73%)
Infection
14 (32%)
6 (27%)
   Upper respiratory tract infection
6 (14%)
1 (4%)
   Nasopharyngitis
5 (11%)
3 (14%)
SAE
2 (4%)a,b
0
Abbreviations: AE, adverse events; QD, daily; 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 entering the study. CT and ultrasound showed pancreatitis due to choledocholithiasis. Cholecystectomy was performed and she was discharged in good condition. Treatment was interrupted but resumed after resolution and she continues in 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 16 July 2025.

 

References

Show
1 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.  
2 Janssen Research & Development, LLC. A study of JNJ-772421113 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: ClinicalTrial.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 Mar 24].  Available from: https://clinicaltrials.gov/study/NCT06095102 NLM identifier: NCT06095102.  
3 Janssen Research & Development, LLC. A study of JNJ-77242113 for the treatment of participants with moderate to severe plaque psoriasis. ln: ClinicalTrial.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 Mar 24]. Available from: https://clinicaltrials.gov/study/NCT06143878 NLM Identifier: NCT06143878.  
4 Janssen Research & Development, LLC. A study of JNJ-77242113 in adolescent and adult participants with moderate to severe plaque psoriasis (ICONIC-LEAD). ln: ClinicalTrial.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 Mar 1]. Available from: https://clinicaltrials.gov/study/NCT06095115 NLM Identifier: NCT06095115.  
5 Janssen Research & Development, LLC. A study of JNJ-77242113 for the treatment of participants with moderate to severe plaque psoriasis (ICONIC-ADVANCE 2). ln: ClinicalTrial.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 Mar 24]. Available from: https://clinicaltrials.gov/study/NCT06220604 NLM Identifier: NCT06220604.  
6 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: ClinicalTrial.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 May 07]. Available from: https://clinicaltrials.gov/study/NCT06934226 NLM identifier: NCT06934226.  
7 Soung J, Chih-ho Hong H, Ehst B, et al. Treatment of plaque psoriasis involving high-impact sites with icotrokinra: subgroup analyses of the phase 3, ICONIC-LEAD trial. Poster presented at: AAD Innovation Academy; July 10-13, 2025; Chicago, IL.  
8 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.  
9 Data on File. Icotrokinra. Clinical Study Report 77242113PSO3001. Janssen Research & Development, LLC. EDMS-RIM-1306643; 2025.