ICOTYDE - Treatment of Hand and Foot Psoriasis

SUMMARY

• The company cannot recommend any practices, procedures, or usage of ICOTYDE that deviate from the approved labeling.
• The safety and efficacy of ICOTYDE in patients with moderate to severe plaque psoriasis (PsO) were evaluated in the ICONIC-ADVANCE 1 (NCT06143878), ICONIC-ADVANCE 2 (NCT06220604), ICONIC-TOTAL (NCT06095102) and ICONIC-LEAD (NCT06095115) phase 3 clinical trials. Summarized below are data specific to hand and foot PsO across these studies.^1-4
  • In ICONIC-TOTAL, at week 16, 42% vs 26% of patients in the ICOTYDE vs placebo (PBO) groups achieved a Physician’s Global Assessment of Hands and/or Feet (hf-PGA) score of 0 or 1 (hf-PGA 0/1; clear or almost clear; treatment difference, 16.7%; 95% confidence interval [CI], -6.2 to 36.8; adjusted P=0.14).^1,2
    • At week 16, 25% and 13% of patients in the ICOTYDE and PBO groups, respectively, achieved an hf‑PGA score of 0.
  • In a pooled analysis of these 4 phase 3 trials, ICOTYDE demonstrated higher clearance vs PBO at week 16 (hf-PGA 0/1: 64% vs 23%; hf-PGA 0: 50% vs 12%), and at week 24, response rates were maintained or improved in the ICOTYDE group vs increased in the PBO→ICOTYDE crossover group (hf-PGA 0/1: 72% vs 64%;
    hf-PGA 0: 57% vs 44%).³

CLINICAL DATA

ICONIC-TOTAL

Gooderham et al (2025)¹ and Lain et al (2025)² evaluated the efficacy and safety of oral ICOTYDE 200 mg once daily in patients ≥12 years of age with plaque PsO affecting special sites (scalp, genitals, and/or hands/feet) in an ongoing phase 3, multicenter, randomized, double-blind, PBO-controlled study.

Study Design/Methods

• Key inclusion criteria¹:
  • Age ≥12 years with plaque PsO diagnosed for ≥26 weeks at screening; candidate for phototherapy or systemic therapy with an inadequate response to ≥1 topical therapies
  • Total body surface area (BSA) involvement ≥1% and an Investigator’s Global Assessment (IGA) score ≥2
  • Involvement of ≥1 high-impact sites with at least moderate severity (scalp-specific IGA score ≥3, static Physician’s Global Assessment of Genitalia score ≥3, and hf-PGA≥3)
• Patients were randomized (2:1) to receive oral ICOTYDE 200 mg or PBO once daily, with PBO crossover to ICOTYDE at week 16.¹
• The primary and select secondary outcome measures are described in Table: Select ICONIC-TOTAL Outcome Measures at Week 16.¹

Results

Patient Characteristics

• A total of 311 patients (ICOTYDE, n=208; PBO, n=103) were included in the study, with 64.3% being male and 78.1% being White. The mean age was 44.7 years (6 patients were ≥12 to <18 years).¹
• In the ICOTYDE and PBO groups, respectively, 23.1% (n=48) and 22.3% (n=23) of patients had at least moderate severity of hand/foot PsO at baseline (hf-PGA score ≥3).¹

Efficacy

• Primary endpoint: At week 16, 56.7% (118/208) vs 5.8% (6/103) of patients receiving ICOTYDE vs PBO, respectively, achieved an IGA 0/1 response (adjusted treatment difference, 51.1%; 95% CI, 42.1-58.8; P<0.001).¹
• Select endpoints are described in Table: Select ICONIC-TOTAL Endpoints.^1,2

Safety

• Through week 16, 50% (105/208) of patients receiving ICOTYDE and 45% (46/103) of patients receiving PBO reported ≥1 adverse events (AEs).²
• Through week 52, 74% (153/208) of patients receiving ICOTYDE and 68% (204/300) of patients in the ICOTYDE combined group reported ≥1 AE (see Table: Adverse Events in ICONIC-TOTAL through Week 52).²
• No new safety signals were identified through week 52.²

Pooled Analyses of Phase 3 Studies

Soung et al (2026)³ evaluated the effects of ICOTYDE in a pooled cohort of patients with PsO involving high-impact sites, including the scalp, genitals, hands/feet, and/or nails, across 4 phase 3 studies (ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2; N=1866).

Study Design/Methods

• For the study design of ICONIC‑TOTAL (N=311), please refer to the relevant section above.
• ICONIC‑LEAD (N=684) enrolled patients aged ≥12 years with moderate to severe plaque PsO defined as BSA ≥10%, Psoriasis Area and Severity Index (PASI) ≥12, and IGA ≥3. Patients were randomized 2:1 to oral ICOTYDE 200 mg once daily or PBO, with PBO crossover at week 16.^3,4
• ICONIC-ADVANCE 1 (N=467) and ICONIC-ADVANCE 2 (N=404) had the same inclusion criteria as ICONIC-LEAD but enrolled only adult patients. The pooled analysis included patients randomized to ICOTYDE or PBO (ADVANCE 1, 2:1; ADVANCE 2, 4:1), with PBO crossover at week 16.³
• Select outcome: hf-PGA 0/1 and hf-PGA 0 response rates through week 24.

Results

Patient Characteristics

• At baseline, an hf-PGA score ≥3 was observed in 25% of patients receiving ICOTYDE (n=319/1297) and in 22% of those receiving PBO (n=124/569).³
  • Moderate hand/foot PsO (hf‑PGA 3) was reported in 80% vs 82%, and severe hand/foot PsO (hf‑PGA 4) in 20% vs 18% of patients receiving ICOTYDE vs PBO, respectively.³ See Table: Baseline Characteristics of Patients with an hf-PGA score ≥3.

Efficacy

• Among patients with a baseline hf‑PGA score ≥3, 64% of ICOTYDE-treated patients achieved hf‑PGA 0/1 at week 16, compared with 23% receiving PBO. At week 24, 72% of ICOTYDE-treated patients and 64% of PBO→ICOTYDE crossover patients achieved hf‑PGA 0/1.³
  • Fifty percent of ICOTYDE‑treated patients achieved hf‑PGA 0 at week 16, compared with 12% receiving PBO. At week 24, 57% of ICOTYDE-treated patients and 44% of PBO→ICOTYDE crossover patients achieved hf-PGA 0.³

Safety

• Pooled phase 3 data from patients with at least moderate high-impact site PsO showed that the AE profile of ICOTYDE was similar to that of PBO through week 16.³ See Table: Pooled Safety in Patients with at Least Moderate High-Impact Site PsO through Week 16.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 9 January 2026.