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ICOTYDE™

(icotrokinra)

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ICOTYDE™ (icotrokinra)
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ICOTYDE - Comparison to Deucravacitinib in the Treatment of Plaque Psoriasis

Last Updated: 06/05/2026

SUMMARY

  • The company cannot recommend any practices, procedures, or usage of ICOTYDE that deviate from the approved labeling.
  • 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).1-5
    • At week 16, a higher proportion of patients in the ICOTYDE group achieved Investigator’s Global Assessment (IGA) 0/1 response vs those receiving deucravacitinib (ADVANCE 1: 68% vs 50%, P<0.001; ADVANCE 2: 71% vs 55%, P<0.001).
    • In addition, more patients in the ICOTYDE cohort experienced clear skin (IGA 0) and Psoriasis Area and Severity Index (PASI) 100 response at week 16 compared to those in the deucravacitinib cohort (ADVANCE 1, IGA 0: 37% vs 16%; ADVANCE 2, IGA 0: 37% vs 18%; ADVANCE 1, PASI 100: 31% vs 11%; ADVANCE 2, PASI 100: 32% vs 14%; all P values were <0.001).
    • Through week 24, across both studies, 58% and 66% of patients receiving ICOTYDE and deucravacitinib, respectively, reported at least 1 adverse event (AE). Serious AEs occurred in 3% of the ICOTYDE group and 3% of the deucravacitinib group.

CLINICAL DATA

ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2

Stein Gold et al (2025 and 2026)1,5 reported results from ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, 2 phase 3, multicenter, randomized, double-blind clinical trials evaluating the efficacy and safety of ICOTYDE compared to 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
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
  • Nonplaque form of PsO (eg, erythrodermic, guttate, or pustular)
  • Primary efficacy failure or clinically significant side effects related to IL-23 or TYK2 inhibitors (except for prior IL-12/23 biologic failure)
Abbreviations: 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 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.

ICONIC-ADVANCE Program Study Design1,2

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


Select Endpoints in the ICONIC-ADVANCE Program1
Key Secondary Endpoints
Time Frame
ICOTYDE vs 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).
  • 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, n (%)
223 (72)
105 (67)
200 (65)
218 (68)
55 (67)
223 (68)
White race, n (%)
231 (74)
118 (76)
221 (72)
274 (85)
65 (79)
265 (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), n (%)
251 (81)
123 (79)
242 (79)
252 (78)
67 (82)
267 (82)
IGA score of 4 (severe), n (%)
60 (19)
33 (21)
65 (21)
70 (22)
15 (18)
60 (18)
Previous PsO Therapy
Systemic therapy, n (%)a
236 (76)
110 (71)
225 (73)
225 (70)
58 (71)
230 (70)
   Phototherapyb
112 (36)
53 (34)
97 (32)
98 (30)
31 (38)
109 (33)
   Conventional non-biologicsc
171 (55)
79 (51)
152 (50)
165 (51)
39 (48)
163 (50)
   Novel non-biologicsd
22 (7)
12 (8)
38 (12)
16 (5)
3 (4)
12 (4)
   Biologic therapye
86 (28)
42 (27)
80 (26)
78 (24)
26 (32)
77 (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 nonbiologic systemics, novel nonbiologic 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 at Week 16 and 24


Key Secondary Endpoints (ICOTYDE vs Deucravacitinib)1,3,4
% (n)
ICONIC-ADVANCE 1
ICONIC-ADVANCE 2
ICO
(n=311)
Deucra
(n=307)
Difference
% (95% CI)
Adjusted
P-value
ICO
(n=320)
Deucra
(n=322)
Difference
% (95% CI)
Adjusted
P-value
IGA 0/1 at week 16a
68 (213)
50 (154)
18 (11-26)
P<0.001
71 (227)
55 (177)
16 (9-23)
P<0.001
PASI 75 at week 16
74 (231)
57 (176)
17 (10-24)
P<0.001
78 (249)
62 (198)
17 (10-23)
P<0.001
IGA 0 at week 16a
37 (114)
16 (48)
21 (14-28)
P<0.001
37 (118)
18 (57)
19 (13-26)
P<0.001
PASI 90 at week 16
55 (171)
30 (91)
25 (18-33)
P<0.001
58 (184)
35 (111)
23 (16-30)
P<0.001
PASI 100 at week 16
31 (97)
11 (34)
20 (14-26)
P<0.001
32 (102)
14 (46)
18 (11-24)
P<0.001
PSSD Symptom score 0 at week 16b
24 (68)
9 (25)
14 (8-21)
P<0.001
22 (64)
13 (36)
9 (3-15)
P=0.005
IGA 0 at week 24a
48 (150)
21 (63)
28 (20-35)
P<0.001
40 (128)
21 (68)
19 (12-26)
P<0.001
PASI 90 at week 24
66 (205)
41 (127)
24 (17-32)
P<0.001
65 (208)
44 (141)
21 (14-29)
P<0.001
PASI 100 at week 24
41 (129)
16 (49)
26 (19-32)
P<0.001
33 (107)
16 (52)
17 (11-24)
P<0.001
IGA 0/1 at week 24a
74 (230)
52 (161)
22 (14-29)
P<0.001
69 (220)
56 (179)
13 (6-21)
P<0.001
PASI 75 at week 24
82 (254)
64 (196)
18 (11-25)
P<0.001
83 (265)
67 (216)
16 (9-23)
P<0.001
Abbreviations: CI, confidence interval; Deucra, deucravacitinib; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PSSD, Psoriasis Symptoms and Signs Diary.
aAmong the 311 and 307 patients with an IGA score ≥2 at baseline in the ICO and Deucra groups, respectively, in ICONIC-ADVANCE 1, and 320 and 322, respectively, in ICONIC-ADVANCE 2.
bAmong the 286 and 272 patients with a baseline PSSD Symptom score >0 in the ICO and Deucra groups, respectively, in ICONIC-ADVANCE 1, and 296 and 282 patients, respectively, in ICONIC-ADVANCE 2.
Note: ICONIC-ADVANCE 2 enrolled 731 patients, of which 723 patients were evaluable for efficacy.

Safety through Week 24


Combined AEs from the ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 Safety Analysis Set through Week 245
AEsa
PBO-controlled
(W0-16)
Active Comparator-controlled (W0-24)
ICO
(n=632)
PBO
(n=237)
ICO
(n=632)
Deucra
(n=634)
Mean weeks/total PY of follow-up
16/193
16/70
24/285
23/283
Any AE, n (%)
308 (49)
137 (58)
368 (58)
417 (66)
   Incidence/100 PY (95% CI)
230
(205-256)
316
(257-364)
207
(186-229)
269
(243-295)
Serious AE, n (%)
14 (2)
4 (2)
18 (3)
20 (3)
   Incidence/100 PY (95% CI)
7 (3-11)
6 (<1-9)
6 (3-9)
7 (4-10)
AE leading to discontinuation, n (%)
14 (2)
12 (5)
17 (3)
19 (3)
   Incidence/100 PY (95% CI)
7 (3-11)
17 (7-25)
6 (3-9)
7 (4-10)
Infection, n (%)
146 (23)
74 (31)
193 (31)
254 (40)
   Incidence/100 PY (95% CI)
87
(72-100)
130
(96-154)
82
(70-93)
119
(104-134)
Serious infection, n (%)
1 (<1)
1 (<1)
3 (<1)
5 (1)
   Incidence/100 PY (95% CI)
1 (0-3)
1 (0-9)
1 (<1-3)
2 (1-4)
Gastrointestinal AE, n (%)
45 (7)
14 (6)
55 (9)
82 (13)
   Incidence/100 PY (95% CI)
24 (17-32)
21 (11-36)
20 (15-26)
31 (25-38)
Malignancy, n (%)
3 (<1)
1 (<1)
3 (<1)
2 (<1)
   Incidence/100 PY (95% CI)
2 (<1-5)
1 (0-9)
1 (<1-3)
1 (<1-3)
Abbreviations: AE, adverse event; CI, confidence interval; Deucra, deucravacitinib; ICO, ICOTYDE; PBO, placebo; PY, patient‑years; W, week.
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).

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 11 May 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, 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.  
3 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.  
4 Data on File. Week 24 Clinical Study Report 77242113PSO3004 Addendum 1. Janssen Research & Development, LLC. EDMS-RIM-1877555; 2026.  
5 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.  

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