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(icotrokinra)

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ICOTYDE™ (icotrokinra)
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ICOTYDE – Previous Experience with Deucravacitinib or Apremilast in Patients with Plaque Psoriasis

Last Updated: 04/28/2026

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 ICOTYDE 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 ICOTYDE, respectively, were previously exposed to apremilast or tofacitinib.
    • The skin clearance rates were observed at week 52 in patients who transitioned from deucravacitinib→ICOTYDE (ADVANCE 1/ADVANCE 2: Investigator’s Global Assessment [IGA] 0 or 1, 75%/80%; Psoriasis Area and Severity Index [PASI] 90, 71%/78%; IGA 0, 45%/57%; PASI 100, 42%/52%).2,3
    • Through week 52, across both studies, 65% of the patients receiving ICOTYDE reported ≥1 adverse event (AE), and 4% reported serious AEs.2
  • ICONIC-LEAD is an ongoing, phase 3, multicenter, randomized, double-blind, PBO-controlled study (NCT06095115) evaluating the efficacy and safety of oral ICOTYDE 200 mg once daily in patients ≥12 years of age with moderate to severe plaque PsO.4
    • In the ICOTYDE 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 ICOTYDE 200 mg once daily in patients ≥12 years of age with plaque PsO and high-impact site involvement.5
    • In the ICOTYDE 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 and 2026)1,2 evaluated the efficacy and safety of oral ICOTYDE 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 21,6
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 ICOTYDE 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 ICOTYDE 200 mg once daily, PBO, or oral deucravacitinib 6 mg, with PBO crossover to ICOTYDE at week 16 and deucravacitinib crossover to ICOTYDE 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 Design1,7

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


Select Key Endpoints in the ICONIC-ADVANCE Program1
Key Secondary Endpoints
Time Frame
ICOTYDE 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. The safety analysis included all randomized and treated patients. Of note, safety data from ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 were combined to identify any uncommon 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)
46.9 (13)
46.3 (14)
45.9 (14)
48.4 (14)
45.6 (13)
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)
17.88 (13)
16.81 (13)
17.43 (13)
21.21 (15)
16.82 (12)
PASI total score (0-72), median (IQR)
18.60
(16-23)
17.15
(14-22)
18.00
(15-23)
18.00
(15-22)
17.95
(14-24)
17.60 (15-21)
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, ICOTYDE; 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.
Efficacy through Week 52

Select Endpoints through Week 522,3,8
Endpoint
ICONIC-ADVANCE 1
ICONIC-ADVANCE 2
Deucra
Deucra→ICO
Deucra
Deucra→ICO
IGA/PASI at week 24
n=307
n=322
   IGA 0/1, %
52
-
56
-
   PASI 90, %
41
-
44
-
   IGA 0, %
21
-
21
-
   PASI 100, %
16
-
16
-
IGA/PASI at week 52
n=283
n=296
   IGA 0/1, %
-
75
-
80
   PASI 90, %
-
71
-
78
   IGA 0, %
-
45
-
57
   PASI 100, %
-
42
-
52
CMI at week 52
n=218
n=223
   PSSD itch score,a %
-
81
-
84
PSSD at week 52
n=222
n=259
   Symptom score 0,a,b %
-
38
-
43
Abbreviations: CMI, clinically meaningful improvement; Deucra, deucravacitinib; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; PSSD, Psoriasis Symptoms and Signs Diary.
aAmong patients with a baseline PSSD itch score ≥4 or PSSD symptom score >0.
bData impacted by a translation error in the German 7-day recall version of the PSSD after week 24 were excluded.
Note: ICONIC-ADVANCE 2 enrolled 731 patients, of which 723 patients were evaluable for efficacy.
Safety through Week 52

Combined AEs from ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 through Week 522
AEa
PBO-Controlled
(Through Week 16)
Active Comparator-Controlled
(Through Week 24)
Through Week 52
ICO
(n=632)
PBO
(n=237)
ICO
(n=632)
Deucra
(n=634)
ICO
(n=1431)b
Mean weeks/total PY of follow-up
16/193
16/70
24/285
23/283
39/1057
Any AE, n (%)
308 (49)
137 (58)
368 (58)
417 (66)
931 (65)
   Incidence/100 PY (95% CI)
230
(205-256)
316
(257-364)
207
(186-229)
269
(243-295)
169
(158-180)
Serious AE, n (%)
14 (2)
4 (2)
18 (3)
20 (3)
56 (4)
   Incidence/100 PY (95% CI)
7 (3-11)
6 (<1-9)
6 (3-9)
7 (4-10)
5 (4-7)
AE leading to discontinuation, n (%)
14 (2)
12 (5)
17 (3)
19 (3)
32 (2)
   Incidence/100 PY (95% CI)
7 (3-11)
17 (7-25)
6 (3-9)
7 (4-10)
3 (2-4)
Infection, n (%)
146 (23)
74 (31)
193 (31)
254 (40)
610 (43)
   Incidence/100 PY (95% CI)
87
(72-100)
130
(96-154)
82
(70-93)
119
(104-134)
80
(73-86)
Serious infection, n (%)
1 (<1)
1 (<1)
3 (<1)
5 (1)
10 (1)
   Incidence/100 PY (95% CI)
1 (0-3)
1 (0-9)
1 (<1-3)
2 (1-4)
1 (<1-2)
Gastrointestinal AE, n (%)
45 (7)
14 (6)
55 (9)
82 (13)
135 (9)
   Incidence/100 PY (95% CI)
24 (17-32)
21 (11-36)
20 (15-26)
31 (25-38)
14 (11-16)
Malignancy, n (%)
3 (<1)
1 (<1)
3 (<1)
2 (<1)
6 (<1)
   Incidence/100 PY (95% CI)
2 (<1-5)
1 (0-9)
1 (<1-3)
1 (<1-3)
1 (<1-1)
Abbreviations: AE, adverse event; CI, confidence interval; Deucra, deucravacitinib; ICO, ICOTYDE; PBO, placebo; PY, patient-years.
aThe safety analysis set included all randomized and treated patients; ADVANCE 1 and ADVANCE 2: PBO, n=155/82 (PBO→ICO, n=141/74); ICO, n=310/322; Deucra, n=307/327 (Deucra→ICO, n=283/301).
bIncludes patients receiving ICO through week 52 and data after week 16 for patients receiving PBO and after week 24 for patients receiving Deucra who transitioned to ICO.

ICONIC-LEAD

Bissonnette et al (2025)4 evaluated the efficacy and safety of oral ICOTYDE 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-LEAD4,9
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 ICOTYDE
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 ICOTYDE 200 mg once daily or PBO daily, with PBO crossover to ICOTYDE at week 16.4

Results

Select Baseline Demographics and Clinical Characteristics4
  • A total of 684 (ICOTYDE, n=456; PBO, n=228) patients were included in the study. Of those, 66 were adolescents ≥12 and <18 years old (ICOTYDE, n=44; PBO, n=22).
  • The mean (standard deviation [SD]) age was 42.4 (16.3) in the ICOTYDE 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 ICOTYDE 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, ICOTYDE =75%, PBO=76%).
  • In the ICOTYDE 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)5 evaluated the efficacy and safety of oral ICOTYDE 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-TOTAL5,10
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 ICOTYDE
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 ICOTYDE 200 mg once daily or PBO, with PBO crossover to ICOTYDE at week 16.5

Results

Select Baseline Demographics and Clinical Characteristics5
  • A total of 311 (ICOTYDE, n=208; PBO, n=103) patients were included in the study. 
  • The mean (SD) age was 45.3 (14.6) in the ICOTYDE 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 ICOTYDE arm and 15.2 (10.5) in the PBO arm. Most patients had an IGA score of 3 (ICOTYDE, 73.6%; PBO, 70.9%).
  • In the ICOTYDE 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 Stein Gold L, Armstrong AW, Soung J, et al. Durability of response with icotrokinra, a targeted oral peptide, in adults with moderate-to-severe plaque psoriasis: one-year results from the phase 3, placebo- and active comparator-controlled ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 trials. Oral Presentation presented at: The American Academy of Dermatology (AAD) Annual Meeting; March 27-31, 2026; Denver, Colorado.  
3 Data on File. Clinical Study Report. 77242113PSO3004. Janssen Research & Development, LLC. EDMS-RIM-1877558; 2026.  
4 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.  
5 Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12).  
6 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.  
7 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.  
8 Data on File. Clinical Study Report. 77242113PSO3004. Janssen Research & Development, LLC. EDMS-RIM-1877555; 2026.  
9 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.  
10 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).