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ICOTYDE™

(icotrokinra)

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ICOTYDE™ (icotrokinra)
Medical Information

ICOTYDE - Onset of Itch Relief in the ICONIC-ADVANCE Program

Last Updated: 08/03/2026

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 ICOTYDE 200 mg daily in adults with moderate to severe plaque psoriasis (PsO).1-3
    • At week 4, more patients receiving ICOTYDE achieved clinically meaningful improvement (CMI; ≥4-point improvement from baseline) in the Psoriasis Symptoms and Signs Diary (PSSD) Itch score vs those receiving PBO (ADVANCE 1: ICOTYDE, 22%; PBO, 7%; P<0.001. ADVANCE 2: ICOTYDE, 21%; PBO, 5%; P=0.008).
    • At week 16, a similar trend was observed (ADVANCE 1: ICOTYDE, 62%; PBO, 17%; P<0.001. ADVANCE 2: ICOTYDE, 60%; PBO, 15%; P<0.001).

CLINICAL DATA

ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2

Stein Gold et al (2025)1 reported results from ADVANCE 1 and 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 Enrollment Criteria for ADVANCE 1 and ADVANCE 21,2
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. ADVANCE 1 and ADVANCE 2 utilized different randomization ratios (2:1:2 and 4:1:4, respectively).1
  • Select key secondary endpoints: Proportion of patients with a CMI in PSSD Itch score at weeks 4 and 16 (ICOTYDE vs PBO) among those with a baseline PSSD Itch score of ≥4.1
  • The safety analysis included all randomized and treated patients. Of note, safety data from ADVANCE 1 and ADVANCE 2 were combined to identify any uncommon adverse events (AEs).1

Results

Patient Characteristics


Select Baseline Demographics and Clinical Characteristics1
ADVANCE 1
ADVANCE 2
ICO
(n=311)
PBO
(n=156)
ICO
(n=322)
PBO
(n=82)
Demographics
Age, years, mean (SD)
47.1 (13)
46.9 (13)
45.9 (14)
48.4 (14)
Male sex, n (%)
223 (72)
105 (67)
218 (68)
55 (67)
White race, n (%)
231 (74)
118 (76)
274 (85)
65 (79)
Disease Characteristics
Duration of PsO, years, mean (SD)
17.52 (11)
17.88 (13)
17.43 (13)
21.21 (15)
PASI total score (0-72), median (IQR)
18.60 (16, 23)
17.15 (14, 22)
18.00 (15, 22)
17.95 (14, 24)
IGA score of 3 (moderate), n (%)
251 (81)
123 (79)
252 (78)
67 (82)
IGA score of 4 (severe), n (%)
60 (19)
33 (21)
70 (22)
15 (18)
PSSD itch scorea,
median (IQR)
7
(5.0, 8.0)
6
(4.0, 8.0)
7
(5.0, 8.0)
7
(4.0, 8.0)
Abbreviations: ICO, ICOTYDE; IGA, Investigator’s Global Assessment; IQR, interquartile range; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis; PSSD, Psoriasis Symptoms and Signs Diary; SD, standard deviation.aAmong 287 and 142 patients in ADVANCE 1 and 299 and 71 patients in ADVANCE 2 in the ICOTYDE and PBO groups, respectively.

Efficacy


CMI in PSSD Itch Score in the ICONIC ADVANCE Programa,1-3
n (%)
ADVANCE 1
ADVANCE 2
ICO
(n=251)
PBO
(n=115)
Difference (95% CI)
ICO
(n=256)
PBO
(n=60)
Difference (95% CI)
CMI in PSSD Itch
score at week 4
56 (22)
8 (7)
15 (8-22)
P<0.001
54 (21)
3 (5)
16 (6-23)
P=0.008
CMI in PSSD Itch
score at week 16
155 (62)
19 (17)
45 (35-54) P<0.001
154 (60)
9 (15)
46 (34-56) P<0.001
Abbreviations: CMI, clinically meaningful improvement; ICO, ICOTYDE; PBO, placebo; PSSD, Psoriasis Symptoms and Signs Diary.aAmong patients with a baseline PSSD itch score of ≥4.

Safety


Combined AEs in the ADVANCE 1 and ADVANCE 2 Safety Analysis Set through Week 161
ICO
(n=632)
PBO
(n=237)
Mean weeks of follow-up (SD)
15.9 (1.88)
15.5 (2.69)
Any AE, n (%)
303 (48)
136 (57)
AEs occurring in ≥5% of patients, n (%)a
    Headache
26 (4)
11 (5)
    Nasopharyngitis
37 (6)
13 (5)
    Upper respiratory tract infection
23 (4)
8 (3)
Serious AE, n (%)
14 (2)
4 (2)
    Serious infection
1 (<1)
1 (<1)
AE leading to discontinuation, n (%)
13 (2)
12 (5)
Gastrointestinal AE, n (%)
45 (7)
15 (6)
Malignancy, n (%)
3 (<1)
1 (<1)
Active TB, n
0
0
Abbreviations: AE, adverse event; ICO, ICOTYDE; PBO, placebo; SD, standard deviation; TB, tuberculosis.aIn any treatment group.
Note: The safety analysis set included all randomized and treated patients.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 17 June 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. 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.  
3 Data on File. Week 24 Clinical Study Report 77242113PSO3004 Addendum 1. Janssen Research & Development, LLC. EDMS-RIM-1877555; 2026.  

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