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icotrokinra

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Icotrokinra – Previous Experience with Deucravacitinib or Apremilast in Patients with Plaque Psoriasis

Last Updated: 03/15/2026

SUMMARY

  • ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 are ongoing, phase 3, multicenter, randomized, double-blind, placebo (PBO)- and active comparator (deucravacitinib)–controlled studies (NCT06143878 and NCT06220604) evaluating the efficacy and safety of oral icotrokinra 200 mg once daily in adults with moderate to severe plaque psoriasis (PsO).1 
    • In ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, 7% and 5% of patients randomized to icotrokinra, respectively, were previously exposed to apremilast or tofacitinib.
    • Data are not yet available from the group of patients who were randomized to deucravacitinib at baseline and crossed over to receive icotrokinra at week 24. Summarized below are the study designs and patient baseline characteristics.
  • ICONIC-LEAD is an ongoing, phase 3, multicenter, randomized, double-blind, PBO-controlled study (NCT06095115) evaluating the efficacy and safety of oral icotrokinra 200 mg once daily in patients ≥12 years of age with moderate to severe plaque PsO.2 
    • In the icotrokinra group, 8% of patients were previously exposed to apremilast, deucravacitinib, and/or tofacitinib.
  • ICONIC-TOTAL is an ongoing, phase 3, multicenter, randomized, double-blind, PBO-controlled study (NCT06095102) evaluating the efficacy and safety of oral icotrokinra 200 mg once daily in patients ≥12 years of age with plaque PsO and high-impact site involvement.3 
    • In the icotrokinra group, 7.2% of patients were previously exposed to apremilast, deucravacitinib, and/or tofacitinib.

CLINICAL DATA

ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2

Stein Gold et al (2025)1 evaluated the efficacy and safety of oral icotrokinra compared to PBO and deucravacitinib for the treatment of adults with moderate to severe plaque PsO.

Study Design/Methods


Select Inclusion/Exclusion Criteria for ICONIC-ADVANCE 1 and ICONIC-ADVANCE 21,4 
Inclusion Criteria
Exclusion Criteria
  • Adults with moderate to severe plaque PsO diagnosed for ≥26 weeks at screening
  • Total BSA involvement of ≥10%, PASI score of ≥12, and IGA score of ≥3 at screening
  • Candidate for phototherapy or systemic treatment
  • Previously received icotrokinra or deucravacitinib
  • Systemic immunomodulating treatments including but not limited to apremilast within 4 weeks prior to the first administration of study drug
  • Primary efficacy failure or clinically significant AE related to IL-23 or TYK2 inhibitors (prior IL-12/23 biologic failure was allowed)
Abbreviations: AE, adverse event; BSA, body surface area; IGA, Investigator’s Global Assessment; IL, interleukin; PASI, Psoriasis Area and Severity Index; PsO, psoriasis; TYK2, tyrosine kinase 2.
  • Patients were randomized to oral icotrokinra 200 mg once daily, PBO, or oral deucravacitinib 6 mg, with PBO crossover to icotrokinra at week 16 and deucravacitinib crossover to icotrokinra at week 24. ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 utilized different randomization ratios (2:1:2 and 4:1:4, respectively). See Figure: ICONIC-ADVANCE Program Study Design.1 

ICONIC-ADVANCE Program Study Design1,5

Abbreviations: ADV, ICONIC-ADVANCE; Deucra, deucravacitinib; ICO, icotrokinra; PBO, placebo; R, randomized; QD, daily; W, week.


Select Key Outcomes in the ICONIC-ADVANCE Program1 
Coprimary Endpoints
Time Frame
Icotrokinra versus PBO
Percentage of patients who achieved an IGA score of 0 (clear skin) or 1 (almost clear skin) with a ≥2-grade improvement from baseline
Week 16
Percentage of patients who achieved PASI 90 response
Week 16
Key Secondary Endpoints
Icotrokinra versus deucravacitinib
Percentage of patients who achieved an IGA score of 0 (clear skin) or 1 (almost clear skin) with a ≥2-grade improvement from baseline
Weeks 16 and 24
Percentage of patients who achieved IGA score of 0 (clear skin)
Weeks 16 and 24
Percentage of patients who achieved PASI 75, PASI 90, and PASI 100 responses
Weeks 16 and 24
Percentage of patients who achieved PSSD symptom score of 0
Week 16
Abbreviations: IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PSSD, Psoriasis Symptoms and Signs Diary.Note: Additional details regarding study outcomes can be found on clinicaltrials.gov (ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2).
  • In both studies, the efficacy analysis included all randomized patients, with a composite strategy (non-responder imputation) being utilized for the coprimary endpoints. The safety analysis set in both studies included all randomized and treated patients. Of note, safety data from ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 were combined to identify any uncommon adverse events (AEs).1 

Results

Patient Characteristics

Select Baseline Demographics and Clinical Characteristics1 
ICONIC-ADVANCE 1
ICONIC-ADVANCE 2
ICO
(n=311)
PBO
(n=156)
Deucra (n=307)
ICO (n=322)
PBO (n=82)
Deucra (n=327)
Demographics
Age, years, mean (SD)
47.1 (13.19)
46.9 (12.78)
46.3 (13.87)
45.9 (13.78)
48.4 (13.90)
45.6 (13.22)
Male sex, %
72
67
65
68
67
68
Race, Asian/Black/White, %
22/1/74
22/2/76
25/1/72
11/3/85
18/2/79
12/3/81
Disease Characteristics
Duration of PsO, years, mean (SD)
17.52 (11.10)
17.88 (12.75)
16.81 (12.81)
17.43 (13.38)
21.21 (15.17)
16.82 (12.03)
PASI total score (0-72), median (IQR)
18.60 (15.50,
22.70)
17.15 (14.40,
21.65)
18.00 (15.00,
23.40)
18.00
(15.10,
22.20)
17.95
(14.30,
23.60)
17.60 (15.20,
21.40)
IGA score of 3 (moderate), %
81
79
79
78
82
82
IGA score of 4 (severe), %
19
21
21
22
18
18
Previous PsO Therapy, %
Systemic therapya
76
71
73
70
71
70
Phototherapyb
36
34
32
30
38
33
Conventional non-biologicsc
55
51
50
51
48
50
Novel non-biologicsd
7
8
12
5
4
4
Biologic therapye
28
27
26
24
32
24
Abbreviations: Deucra, deucravacitinib; ICO, icotrokinra; IGA, Investigator’s Global Assessment; IQR, interquartile range; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis; PUVA, psoralen and ultraviolet A radiation; SD, standard deviation; UVB, ultraviolet B.
aIncludes conventional non-biologic systemics, novel non-biologic systemics, 1,25-vitamin D3 and analogues, phototherapy, and biologics.
bIncludes PUVA and UVB.cIncludes PUVA, methotrexate, cyclosporine, acitretin, azathioprine, and fumarate.dIncludes apremilast and tofacitinib.eIncludes etanercept, infliximab, adalimumab, ustekinumab, briakinumab, secukinumab, ixekizumab, brodalumab, guselkumab, risankizumab, tildrakizumab, alefacept, efalizumab, natalizumab, and certolizumab pegol.

ICONIC-LEAD

Bissonnette et al (2025)2 evaluated the efficacy and safety of oral icotrokinra compared to PBO for the treatment of patients ≥12 years of age with moderate to severe plaque PsO.

Study Design/Methods


Select Inclusion and Exclusion Criteria for ICONIC-LEAD2,6 
Inclusion Criteria
Exclusion Criteria
  • Age ≥12 years with moderate to severe plaque PsO diagnosed for ≥26 weeks at screening
  • Candidate for phototherapy or systemic therapy
  • Total BSA involvement ≥10%, total PASI score ≥12, and IGA score ≥3 at screening and baseline
  • Body weight ≥40 kg (adolescents)
  • Systemic immunomodulating treatments including but not limited to apremilast and deucravacitinib within 4 weeks prior to the first administration of study drug
  • Prior primary efficacy failure or clinically significant AE to ≥1 biological agent targeting IL-23 (prior IL-12/23 biologic failure was allowed)
  • Prior use of icotrokinra
Abbreviations: AE, adverse event; BSA, body surface area; IGA, Investigator’s Global Assessment; IL, interleukin; PASI, Psoriasis Area and Severity Index; PsO, psoriasis.
  • Patients were randomized (2:1) to oral icotrokinra 200 mg once daily or PBO daily, with PBO crossover to icotrokinra at week 16.2 

Results

Select Baseline Demographics and Clinical Characteristics2
  • A total of 684 (icotrokinra, n=456; PBO, n=228) patients were included in the study. Of those, 66 were adolescents ≥12 and <18 years old (icotrokinra, n=44; PBO, n=22).
  • The mean (standard deviation [SD]) age was 42.4 (16.3) in the icotrokinra arm and 43.2 (16.6) in the PBO arm. Most patients were male (65%) and White (72%).
  • The mean (SD) years of PsO duration was 17.3 (13.9) in the icotrokinra arm and 16.6 (12.7) in the PBO arm. Most patients had PsO of moderate severity (Investigator’s Global Assessment [IGA] score of 3, icotrokinra=75%, PBO=76%).
  • In the icotrokinra and PBO groups, 8% and 7% of patients, respectively, had novel non-biologics (including apremilast, deucravacitinib, and tofacitinib) as previous therapy for PsO.

ICONIC-TOTAL

Gooderham et al (2025)3 evaluated the efficacy and safety of oral icotrokinra compared to PBO for the treatment of patients ≥12 years of age with plaque PsO and high-impact site involvement.

Study Design/Methods


Select Inclusion/Exclusion Criteria for ICONIC-TOTAL3,7 
Inclusion Criteria
Exclusion Criteria
  • Age ≥12 years with plaque PsO diagnosed for ≥26 weeks
  • Candidate for phototherapy or systemic therapy and failed ≥1 topical therapy
  • Total BSA involvement ≥1% and IGA score ≥2
  • 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
  • Systemic immunomodulating treatments including but not limited to apremilast and deucravacitinib within 4 weeks prior to the first administration of study drug.
  • Prior primary efficacy failure or clinically significant AE to ≥1 biological agent targeting IL-23 (prior IL-12/23 biologic failure was allowed)
  • Previously treated with icotrokinra
Abbreviations: AE, adverse event; BSA, body surface area; hf-PGA, Physician’s Global Assessment of hands and feet; IGA, Investigator’s Global Assessment; IL, interleukin; PsO, psoriasis; sPGA-G, static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global Assessment.
  • Patients were randomized (2:1) to oral icotrokinra 200 mg once daily or PBO, with PBO crossover to icotrokinra at week 16.3 

Results

Select Baseline Demographics and Clinical Characteristics3
  • A total of 311 (icotrokinra, n=208; PBO, n=103) patients were included in the study. 
  • The mean (SD) age was 45.3 (14.6) in the icotrokinra arm and 43.5 (13.8) in the PBO arm. Most patients were male (64.3%) and White (78.1%).
  • The mean (SD) years of PsO duration was 16.8 (13.3) in the icotrokinra arm and 15.2 (10.5) in the PBO arm. Most patients had an IGA score of 3 (icotrokinra, 73.6%; PBO, 70.9%).
  • In the icotrokinra and PBO groups, 7.2% and 6.8% of patients, respectively, had novel non-biologics (including apremilast, deucravacitinib, and tofacitinib) as previous therapy for PsO.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 26 January 2026.

References

Show
1 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. Lancet. 2025;406(10510):1363-1374.  
2 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.  
3 Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12).  
4 Stein Gold L, Armstrong AW, Bissonnette R, et al. Supplement to: 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. Lancet. 2025;406(10510):1363-1374.  
5 Stein Gold L, Armstrong AW, Bissonnette R, et al. Icotrokinra demonstrated superior responses compared with placebo and deucravacitinib in the treatment of moderate-to-severe plaque psoriasis. Oral presentation presented at: European Academy of Dermatology and Venereology (EADV); September 17-20, 2025; Paris, France.  
6 Bissonnette R, Soung J, Hebert AA, et al. Protocol to: Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393(18):1784-1795.  
7 Gooderham M, Lain E, Bissonnette R, et al. Protocol to: Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12).