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icotrokinra

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Icotrokinra – Overview of the ICONIC-TOTAL Clinical Trial

Last Updated: 09/29/2025

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-TOTAL is an ongoing, phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled study (NCT06095102) evaluating the efficacy and safety of icotrokinra 200 mg daily in patients ≥12 years of age with plaque PsO and high-impact site involvement.1,2    
    • At week 16, the primary endpoint for Investigator’s Global Assessment (IGA) score of 0/1 and ≥2-grade improvement from baseline was achieved by significantly more patients receiving icotrokinra (57%) compared to patients receiving PBO (6%; P<0.001).1  
    • At week 16, the major secondary endpoints of scalp-specific IGA [ss-IGA] 0/1, was achieved by 66% of patients receiving icotrokinra compared to 11% of patients receiving PBO (P<0.001), static Physician’s Global Assessment of Genitalia [sPGA-G] 0/1 was achieved by 77% of patients receiving icotrokinra compared to 21% of patients receiving PBO (P<0.001), and Physician’s Global Assessment of hands and feet [hf-PGA] 0/1 was achieved by 42% of patients receiving icotrokinra compared to 26% of patients receiving PBO.
    • Through week 16, 50% of patients receiving icotrokinra and 42% of patients receiving PBO reported ≥1 adverse event (AE). No new safety signals were identified through week 16.1 

CLINICAL DATA

ICONIC-TOTAL

Gooderham et al (2025)1 reported results through week 16 from ICONIC-TOTAL, a phase 3 clinical trial evaluating the efficacy and safety of icotrokinra compared to PBO for the treatment of adults and adolescents (≥12 years of age) with plaque PsO and high-impact site involvement.

Study Design/Methods

  • Key inclusion criteria are as follows:1,2  
    • Adults and adolescents (≥12 years of age) with a diagnosis of plaque PsO for ≥26 weeks (with or without psoriatic arthritis [PsA]) who were candidates for phototherapy or systemic therapy and failed ≥1 topical therapy
    • Total body surface area (BSA) ≥1%, and IGA ≥2 at screening and baseline
    • Involvement of ≥1 high-impact site with at least moderate severity:
      • Scalp with ss-IGA ≥3
      • Genital with sPGA-G ≥3
      • Hand/Foot with hf-PGA ≥3
  • Key exclusion criteria are as follows:2  
    • 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
    • Patients with palmoplantar pustulosis of the palmoplantar area (if hf-PGA ≥3 at baseline) or dermatoses (other than plaque PsO)
  • Adult and adolescent patients were randomized in a 2:1 ratio to receive icotrokinra 200 mg oral (PO) or PBO once daily with PBO crossover to icotrokinra at week 16.1    
  • Safety will be evaluated through week 1601    
  • The primary and select key secondary outcome measures are described in Table: ICONIC-TOTAL Key Clinical Trial Outcome Measures at Week 16.1,2  

ICONIC-TOTAL Key Clinical Trial Outcome Measures at Week 161,2  
Primary Endpoint
Percentage of patients who achieved an IGA score of cleared (0) or minimal (1) and ≥2-grade improvement from baseline
Key Secondary Endpoints
Percentage of patients who achieved IGA score of cleared (0)
Percentage of patients who achieved ss-IGA score of absence of disease (0) or very mild disease (1)
Percentage of patients who achieved sPGA-G score of clear (0) or minimal (1)
Percentage of patients who achieved hf-PGA score of clear (0) or almost clear (1)
Percentage of patients who achieved PSSI 90 response
Percentage of patients who achieved PSSD Symptom Score of 0
Percentage of patients who achieved ≥4-point improvement from baseline in Scalp Itch NRS score
Note: Additional details regarding study outcome definitions can be found on clinicaltrials.gov.
Abbreviations: hf-PGA, Physician’s Global Assessment of hands and feet; IGA, Investigator’s Global Assessment; PGA, Physician’s Global Assessment; NRS, numeric rating scale; PSSD, Psoriasis Symptom and Sign Diary; PSSI, Psoriasis Scalp Severity Index; sPGA-G, static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global Assessment.

Results

Patient Characteristics

Baseline Demographics and Clinical Characteristics1  
Icotrokinra 200 mg QD
(n=208)
Placebo
(n=103)
Demographics
Age, years, mean (SD)
45.3 (14.6)
43.5 (13.8)
Male, %
66
61
White, %
77
80
BMI, kg/m2, mean (SD)a
29.0 (6.6)
29.4 (8.1)
Disease Characteristics
PsO disease duration, years, mean (SD)
16.8 (13.3)
15.2 (10.5)
% BSA with PsO, mean (SD)
16.6 (13.5)
14.8 (11.7)
   <10%
36
37
   ≥10%
64
63
IGA score, moderate (3), %
74
71
IGA score, severe (4), %
22
21
PASI (0-72), mean (SD)
14.6 (7.6)
14.0 (7.0)
Previous Therapy, %
Phototherapy (PUVA and UVB)
43
31
Systemic therapyb
73
73
Biologic therapyc
34
31
High-Impact Site PsO Severityd
ss-IGA score ≥3, n (%)
167 (80)
85 (83)
   moderate (3), %
80
75
   severe (4)b, %
20
25
sPGA-G score ≥3, n (%)
98 (47)
42 (41)
   moderate (3)b, %
77
69
   severe (4), %
22
29
   very severe (5), %
1
2
hf-PGA score, ≥3, n (%)
48 (23)
23 (22)
   moderate (3), %
65
83
   severe (4), %
35
17
Abbreviations: BMI, body mass index; BSA, body surface area; hf-PGA, Physician’s Global Assessment of hands and feet; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area Severity Index; PGA, Physician’s Global Assessment; PsO, psoriasis; PUVA, psoralen plus ultraviolet A; QD, once daily; SD, standard deviation; sPGA-G, static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global Assessment; UVB, ultraviolet BaIcotrokinra: n=203; Placebo: n=101bIncludes conventional nonbiologic systemics, novel nonbiologic systemics, 1,25-vitamin D3 and analogues, phototherapy, biologics.cIncludes adalimumab, alefacept, briakinumab, brodalumab, certolizumab pegol, efalizumab, etanercept, guselkumab, infliximab, ixekizumab, natalizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumabdPsO involving high-impact sites was not mutually exclusive
Efficacy

Key Clinical Endpoints at Week 161,7  
% (n/N)
Icotrokinra 200 mg QD

Placebo
Proportion of patients achieving:
IGA 0/1 and ≥2-grade improvement from baseline
57 (118/208); P<0.001a,b
6 (6/103)
IGA 0
25 (53/208); P<0.001b
1 (1/103)
ss-IGA 0/1c
66 (110/167); P<0.001d
11 (9/85)
sPGA-G 0/1c
77 (75/98); P<0.001d
21 (9/42)
hf-PGA score 0/1c
42 (20/48)e
26 (6/23)
ss-IGA 0c
49 (82/167); Nominal P<0.001d,f
2 (2/85)
sPGA-G 0c
62 (61/98); Nominal P<0.001d,f
10 (4/42)
PSSD Symptom Score of 0g
16 (31/191); P<0.01b
3 (3/87)
PSSI 90h
57 (96/167); P<0.01i
6 (5/85)
CMI in Scalp Itch NRSj
59 (77/131); P<0.01i
9 (5/58)
Abbreviations: BSA, body surface area; CI, confidence interval; CMI, clinically meaningful improvement (≥4-point improvement from baseline); hf-PGA, Physician’s Global Assessment of hands and feet; IGA, Investigator’s Global Assessment; NRS, numeric rating scale; PSSI, Psoriasis Scalp Severity Index; PSSI 90, reduction from baseline of ≥90% in the PSSI score; QD, once daily; sPGA-G, static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global AssessmentaPrimary endpoint; Treatment difference of 51.1% (95% CI, 42.1-58.8); Treatment difference and 95% CI (using Miettinen-Nurminen method) were calculated adjusting for high-impact site involvement and BSA category using Mantel- Haenszel weights.bP values were calculated based on Cochran-Mantel-Haenszel chi-square test stratified by high-impact site involvement and BSA category, if applicable.cAmong patients with a baseline ss-IGA score, sPGA-G score, or hf-PGA score ≥3dP values were based on Cochran-Mantel-Haenszel chi-square test stratified by geographic region and/or BSA category.eResults were not statistically significantfThese endpoints were not adjusted for multiple comparisons. Therefore, the p-values displayed are nominal, and statistical significance has not been establishedgAmong patients with a baseline PSSD Symptom score>0.hAmong patients with a baseline ss-IGA score ≥3iP values were based on Cochran-Mantel-Haenszel chi-square test stratified by geographic region and BSA categoryjAmong patients with a baseline Scalp Itch NRS score ≥4 and a ss-IGA score ≥3.
Safety
  • Through week 16, 50% (104/208) of patients receiving icotrokinra and 42% (43/103) of patients receiving PBO reported ≥1 AE (see Table: Adverse Events through Week 16).1 
  • No new safety signals were identified through week 16.1 

Adverse Events Through Week 161 
Icotrokinra 200 mg QD
(n=208)
Placebo
(n=103)
Mean weeks of follow-up
16
15.7
Any AE
104 (50%)
43 (42%)
Most common AEs (≥5%)
   Nasopharyngitis
26 (12%)
11 (11%)
   Upper respiratory tract infection
9 (4%)
5 (5%)
   Headache
6 (3%)
6 (6%)
SAEa
1 (<1%)
2 (2%)
Infection
59 (28%)
22 (21%)
   Serious Infection
0
1 (1%)
AE leading to discontinuationb
4 (2%)
3 (3%)
Gastrointestinal AE
15 (7%)
8 (8%)
Active tuberculosis
0
0
Malignancyc
1 (<1%)
0
Abbreviations: AE, adverse events; COVID-19, coronavirus disease 2019; QD, once daily; SAEs, serious adverse events aSAEs through week 16 included COVID-19 pneumonia, sepsis, sciatica, and acute respiratory failure in the placebo group; and hepatitis in the icotrokinra group.bAEs leading to discontinuation through W16 included COVID-19 pneumonia, psoriatic arthropathy, and psoriasis in the placebo group; and vision blurred, visual field defect, laryngitis fungal, malignant melanoma in situ, and headache in the icotrokinra group.cMalignancy reported in the icotrokinra group was malignant melanoma in situ in a patient with a recent personal history of melanoma (in 2021).

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 03 May 2025.

 

References

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1 Gooderham M, Lain E, Bissonnette R, et al. Phase 3 results from an innovative trial design of treating plaque psoriasis involving difficult-to-treat, high-impact sites with icotrokinra, a targeted oral peptide that selectively inhibits the IL-23-receptor. Poster presented at: SID Annual Meeting; May 7-10, 2025; San Diego, CA.  
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 Sep 15].  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 Sep 18]. 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 Sep 15]. 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 Sep 12]. 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 Sep 12]. Available from: https://clinicaltrials.gov/study/NCT06934226 NLM identifier: NCT06934226.  
7 Data on File. Icotrokinra. Clinical Study Report 77242113PSO3003. Janssen Research & Development, LLC. EDMS-RIM-1306699, 1.0; 2025.