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ICOTYDE™ (icotrokinra)
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ICOTYDE – Previous Experience with Biologics 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, 28% and 24% of patients randomized to ICOTYDE, respectively, were previously exposed to biologic therapy.
  • 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.2
    • In the ICOTYDE group, 32% of patients were previously exposed to biologics.
  • 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.3
    • In the ICOTYDE group, 34% of patients were previously exposed to biologics.
  • Across all studies, patients who used any biologic therapy within 12 weeks or 5 half-lives of the first administration of study drug were excluded from the trials.4-6
  • Pooled efficacy data by prior biologic exposure (from ICONIC-ADVANCE 1, ICONIC-ADVANCE 2 and ICONIC-LEAD) are summarized below.7

CLINICAL DATA

ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2

Stein Gold et al (2025)1 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 21,4
Inclusion Criteria
Exclusion Criteria
  • Adults (≥18 years of age) 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
  • Previous use of any biologic therapy (eg, IL-23 inhibitors, IL-17 inhibitors, IL-12/23 inhibitors, TNFα antagonists, natalizumab, belimumab, abatacept, visilizumab, and experimental or investigational therapy) within 12 weeks or 5 half-lives, whichever is longer, 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)
  • Previously received ICOTYDE or deucravacitinib
Abbreviations: AE, adverse event; BSA, body surface area; IGA, Investigator’s Global Assessment;
IL, interleukin; PASI, Psoriasis Area and Severity Index; PsO, psoriasis; TNFα, tumor necrosis factor-alpha;
TYK2, tyrosine kinase 2.
  • Patients were randomized to oral ICOTYDE 200 mg once daily, PBO, or oral deucravacitinib 6 mg once daily, 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).1

Results

Select Baseline Demographics and Clinical Characteristics1
  • A total of 774 patients were randomized in ICONIC-ADVANCE 1 (ICOTYDE n=311; PBO n=156; deucravacitinib n=307).
  • A total of 731 patients were randomized in ICONIC-ADVANCE 2 (ICOTYDE n=322; PBO n=82; deucravacitinib n=327).
  • In ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2:
    • The mean (standard deviation [SD]) age was 46.7 (13.4) and 46.1 (13.6), respectively.
    • Most patients were White (74% and 83%, respectively) and male (68% and 68%, respectively).
    • The mean (SD) years of PsO duration was 17.3 (12.1) and 17.6 (13.1), respectively.
    • Mean (SD) Psoriasis Area and Severity Index (PASI) scores were 20.1 (7.3) and 19.8 (6.9), respectively.
  • In ICONIC-ADVANCE 1, biologics were used as previous PsO therapy by 28%, 27%, and 26% of patients in the ICOTYDE, PBO, and deucravacitinib groups, respectively.
  • In ICONIC-ADVANCE 2, biologics were used as previous PsO therapy by 24%, 32%, and 24% of patients in the ICOTYDE, PBO, and deucravacitinib groups, respectively.
  • Previously used biologics included 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 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-LEAD2,5
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)
  • Previous use of any biologic therapy (eg, IL-23 inhibitors, IL-17 inhibitors, IL-12/23 inhibitors, TNFα antagonists, natalizumab, belimumab, abatacept, visilizumab, and experimental or investigational therapy) within 12 weeks or 5 half-lives, whichever is longer, 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; TNFα, tumor necrosis factor-alpha.
  • Patients were randomized (2:1) to oral ICOTYDE 200 mg once daily or PBO daily, with PBO crossover to ICOTYDE at week 16.2

Results

Select Baseline Demographics and Clinical Characteristics2,8
  • 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 (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:
    • Biologics were used as previous PsO therapy by 32% and 37% of patients, respectively.
    • Tumor necrosis factor-alpha (TNFα) inhibitors were used by 15% and 17% of patients, respectively.
    • Interleukin (IL)-17 inhibitors were used by 10% and 12% of patients, respectively.
    • IL-12/23 inhibitors were used by 11% and 8% of patients, respectively.
    • IL-23 inhibitors were used by 8% and 13% of patients, respectively.
    • Previously used biologics included adalimumab, alefacept, briakinumab, brodalumab, certolizumab pegol, efalizumab, etanercept, guselkumab, infliximab, ixekizumab, natalizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab.

ICONIC-TOTAL

Gooderham et al (2025)3 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-TOTAL3,6
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
  • Previous use of any biologic therapy (eg, IL-23 inhibitors, IL-17 inhibitors, IL-12/23 inhibitors, TNFα antagonists, natalizumab, belimumab, abatacept, visilizumab, and experimental or investigational therapy) within 12 weeks or 5 half-lives, whichever is longer, 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; TNFα, tumor necrosis factor-alpha.
  • Patients were randomized (2:1) to oral ICOTYDE 200 mg once daily or PBO, with PBO crossover to ICOTYDE at week 16.3

Results

Select Baseline Demographics and Clinical Characteristics 3,9
  • 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:
    • Biologics were used as previous PsO therapy by 34.1% and 31.1% of patients, respectively.
    • TNFα inhibitors were used by 13.9% and 14.6% of patients, respectively.
    • IL-23 inhibitors were used by 11.5% and 11.7% of patients, respectively.
    • IL-12/23 inhibitors were used by 10.1% and 7.8% of patients, respectively.
    • IL-17 inhibitors were used by 10.6% and 5.8% of patients, respectively.
    • Previously used biologics included adalimumab, alefacept, briakinumab, brodalumab, certolizumab pegol, efalizumab, etanercept, guselkumab, infliximab, ixekizumab, natalizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab.

Pooled Analysis of Phase 3 studies

Stein Gold et al (2026)7 conducted a pooled analysis of 3 phase 3 studies (ICONIC-LEAD, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2) to evaluate ICOTYDE vs PBO in achieving skin clearance at week 16 across baseline subgroups of high clinical interest.

Study Design/Methods

  • For the study designs of ICONIC-LEAD (N=684), ICONIC-ADVANCE 1 (N=467), and ICONIC-ADVANCE 2 (N=404), please refer to relevant sections above.

Results


Prior Biologic/Systemic Treatment at Baseline7
n (%)
ICO
(n=1089)
PBO
(n=466)
Prior biologic treatmenta
   Present
312 (29)
153 (33)
   Absent
777 (71)
313 (67)
Prior systemic treatmentb
   Present
788 (72)
331 (71)
   Absent
301 (28)
135 (29)
Abbreviations: ICO, ICOTYDE; PBO, placebo.
aBiologic treatment included adalimumab, alefacept, briakinumab, brodalumab, certolizumab pegol, efalizumab, etanercept, guselkumab, infliximab, ixekizumab, natalizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab.
bSystemic treatment included conventional nonbiologic systemics, novel nonbiologic systemics, 1,25-vitamin D3 and analogs, phototherapy, and biologics.

IGA 0/1 Response Rates by Prior Biologic/Systemic Treatment7
%
ICO
(n=1089)
PBO
(n=466)
Proportion Difference
(95% CI)
Prior biologic treatment
   Present
59.9
6.5
52.9 (45.5-59.3)
   Absent
70.5
10.5
59.8 (54.7-64.2)
Prior systemic treatment
   Present
67.6
8.2
58.7 (53.9-63.0)
   Absent
67.1
11.9
56.0 (47.6-62.9)
Abbreviations: CI, confidence interval; ICO, ICOTYDE; PBO, placebo; IGA, Investigator’s Global Assessment.
Safety
  • The mean duration of follow-up in the pooled cohort was 15.9 weeks for ICOTYDE and 15.6 weeks for PBO. The safety data are summarised in the Table: Pooled Safety through Week 16.

Pooled Safety through Week 167
n (%)
ICO
(n=1088)
PBO
(n=465)
Any AE
531 (49)
249 (54)
Most common AEs (≥5%)
   Nasopharyngitis
68 (6)
28 (6)
   Upper respiratory tract infection
53 (5)
24 (5)
Serious AEs
20 (2)
10 (2)
AEs leading to discontinuation
20 (2)
13 (3)
Infections
252 (23)
125 (27)
   Serious infections
2 (<1)
1 (<1)
Gastrointestinal AEs
71 (7)
27 (6)
Malignancy
5 (<1)
1 (<1)
Abbreviations: AE, adverse event; ICO, ICOTYDE; PBO, placebo.
Note: All randomized and treated patients were included in the safety analysis set.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 2 February 2026.

 

References

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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 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.  
6 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).  
7 Stein Gold L, Armstrong AW, Soung J, et al. Consistency of skin clearance with the targeted oral peptide icotrokinra: results from a large pooled cohort of phase 3 study participants with moderate-to-severe plaque psoriasis. Poster presented at: American Academy of Dermatology (AAD) Annual Meeting; March 27-31, 2026; Denver, CO.  
8 Bissonnette R, Soung J, Hebert AA, et al. Supplement to: Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393(18):1784-1795.  
9 Gooderham M, Lain E, Bissonnette R, et al. Supplement to: Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12).