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Iconic Advance

ICONIC-ADVANCE 1/ICONIC-ADVANCE 2

ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2

1505 patients aged ≥18 years with plaque PsO1,2

Two phase 3, multicenter, randomized, double-blind, placebo-controlled and active comparator-
controlled trials evaluating the efficacy and
safety of ICOTYDE 200 mg orally once daily.1,2

Eligibility1,2

  • Moderate to severe plaque psoriasis defined as IGA ≥3, PASI ≥12, and BSA ≥10%
  • Candidates for systemic therapy or phototherapy

Treatment periods2

  • Patients randomized to placebo crossed over to ICOTYDE at Week 16
  • Patients randomized to deucravacitinib crossed over to ICOTYDE at Week 24
  • Patients received open-label ICOTYDE after Week 24 through
    Week 156
  • Safety will be assessed through Week 160

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ADVANCE 1 had 774 patients randomized 2:1:2 between ICOTYDE, placebo, and deucravacitinib, respectively.

ADVANCE 2 had 731 patients randomized 4:1:4 between ICOTYDE, placebo, and deucravacitinib, respectively.

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Co-primary endpoints1

  • IGA 0/1 with ≥2-grade improvement from
    baseline vs placebo at Week 16
  • ≥90% improvement from baseline in PASI scores (PASI 90) vs placebo at Week 16

*200 mg orally once daily.

†6 mg orally once daily.

Key inclusion criteria2

  • Plaque PsO for ≥26 weeks
  • BSA ≥10%, PASI ≥12, and IGA ≥3 at screening and baseline
  • Candidate for phototherapy or systemic treatment
  • Aged ≥18 years

Select baseline characteristics1

  • Median affected BSA: 21%
  • Median PASI: 18
  • Severe disease (IGA 4): 20%
  • Previous systemic therapy: 72%
  • Previous use of a biologic: 26%
Iconic Lead

ICONIC-LEAD

ICONIC-LEAD (patients aged ≥12 years)

684 patients aged ≥12 years with plaque PsO1,4

A phase 3, multicenter, randomized, double-blind, placebo-controlled trial with randomized withdrawal and retreatment evaluating the efficacy and safety of ICOTYDE 200 mg orally once daily.1,4

Eligibility1,4

  • Moderate to severe plaque psoriasis defined as IGA ≥3, PASI ≥12, and BSA ≥10%
  • Candidates for systemic therapy or phototherapy

Treatment periods4

  • Patients randomized to placebo crossed over to ICOTYDE at Week 16
  • Adults with a treatment response entered randomized withdrawal and retreatment from Week 24 to Week 52
  • Patients received open-label ICOTYDE from Week 52 to Week 156
  • Safety will be assessed through Week 160

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LEAD had 684 patients (618 adults and 66 adolescents) randomized 2:1 between ICOTYDE and placebo, respectively.

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Co-primary endpoints1

  • IGA 0/1 with ≥2-grade improvement from baseline vs placebo at Week 16
  • The proportion of patients who achieved PASI 90 at Week 16

*200 mg orally once daily.

†Patients were retreated with ICOTYDE after a loss of ≥50% PASI improvement observed at Week 24 or at Week 52 if loss of response was not observed.

Key inclusion criteria4

  • Plaque PsO for ≥26 weeks
  • BSA ≥10%, PASI ≥12, and IGA ≥3 at screening and baseline
  • Candidate for phototherapy or systemic treatment
  • Aged ≥12 years

Select baseline characteristics1

  • Median affected BSA: 20%
  • Median PASI: 17
  • Severe disease (IGA 4): 25%
  • Previous systemic therapy: 72%
  • Previous use of a biologic: 34%
Iconic Total

ICONIC-TOTAL

ICONIC-TOTAL (high-impact areas)

311 patients aged ≥12 years with plaque PsO and high-impact site involvement1,5

A phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and
safety of ICOTYDE 200 mg orally once daily.1,5

Eligibility1,5

  • Patients with plaque psoriasis who had a BSA ≥1%, IGA ≥2, and failed to respond to ≥1 topical therapies
  • At least moderate psoriasis involving one of the following baseline conditions: ss-IGA ≥3, sPGA-G ≥3, and/or hf-PGA ≥3
  • Candidates for systemic therapy or phototherapy

Treatment periods5

  • Patients randomized to placebo crossed over to ICOTYDE at Week 16
  • Efficacy will be evaluated through Week 156
  • Safety will be assessed through Week 160

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TOTAL had 311 adults and adolescents randomized 2:1 between ICOTYDE and placebo, respectively.

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Primary endpoint1

  • IGA 0/1 with ≥2-grade improvement from baseline vs placebo at Week 16

*200 mg orally once daily.

Key inclusion criteria5

  • Plaque PsO for ≥26 weeks
  • BSA ≥1% and IGA ≥2
  • ≥1 high-impact area involvement:
    ss-IGA ≥3, sPGA-G ≥3, and/or hf-PGA ≥3
  • Candidate for phototherapy or systemic treatment
  • Aged ≥12 years

Select baseline characteristics5

  • Scalp PsO (ss-IGA ≥3): 81%
  • Genital PsO (sPGA-G ≥3): 45%
  • Hand/foot PsO (hf-PGA ≥3): 23%

Psoriasis involving high-impact sites was not mutually exclusive.

HOW TO TAKE ICOTYDE

Learn about the once-daily dosing of ICOTYDE1

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BSA, body surface area; hf-PGA, Physician’s Global Assessment of Hands and Feet; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PsO, psoriasis; sPGA-G, Static Physician’s Global Assessment of Genitalia; ss-IGA, Scalp-Specific Investigator’s Global Assessment.

References: 1. ICOTYDE [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Gold LS, 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. doi:10.1016/
S0140-6736(25)01576-4 3. Data on file. Janssen Biotech, Inc. 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. doi:10.1056/NEJMoa2504187 5. Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12):EVIDoa2500155. doi:10.1056/EVIDoa2500155