ICOTYDE - Treatment of Nail 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-TOTAL (NCT06095102), ICONIC-LEAD (NCT06095115), ICONIC-ADVANCE 1 (NCT06143878), and ICONIC-ADVANCE 2 (NCT06220604) phase 3 clinical trials. Summarized below are data specific to patients with nail PsO (baseline modified Nail Psoriasis Severity Index [mNAPSI] scores of >0).^1-4
  • In ICONIC-TOTAL, at week 16, patients receiving ICOTYDE had a 33% improvement in mNAPSI from baseline vs 9% in the placebo (PBO) group.¹
    • At week 52, patients in the ICOTYDE group showed a 62% mean mNAPSI improvement, and patients who switched from PBO achieved nail PsO improvements (59%) comparable to those initially treated with ICOTYDE.^2,5
  • In a pooled analysis of these 4 phase 3 trials that included patients with nail PsO (baseline mNAPSI >0), ICOTYDE led to mean mNAPSI improvement of 35% at week 16 and 50% at week 24. Patients in the PBO group showed -14% improvement at week 16, followed by improvement after PBO→ICOTYDE crossover (26% at week 24).³

CLINICAL DATA

ICONIC-TOTAL

Warren et al (2026)⁵, 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 and at least moderate high-impact site involvement (scalp, genitals, and/or hands/feet) in an ongoing phase 3, multicenter, randomized, double-blind, PBO-controlled study.

Study Design/Methods

• Key inclusion criteria^1,5:
  • Adults (≥18 years) and adolescents (≥12 to <18 years of age) with plaque PsO diagnosed for ≥26 weeks at screening; candidate for phototherapy or systemic therapy with an inadequate response to ≥1 topical therapy
  • Total body surface area (BSA) involvement ≥1% and an Investigator’s Global Assessment (IGA) score ≥2
  • Involvement of ≥1 high-impact site with at least moderate severity (scalp-specific IGA score ≥3, static Physician’s Global Assessment of Genitalia score ≥3, and Physician’s Global Assessment of hands and feet score ≥3)
• Patients were randomized (2:1) to receive oral ICOTYDE 200 mg or PBO once daily, with PBO crossover to ICOTYDE at week 16 and active treatment through week 156.^1,5
• The primary and select secondary outcome measures are described in Table: Select ICONIC-TOTAL Outcome Measures at Week 16.

Results

Patient Characteristics

• A total of 311 patients (ICOTYDE, n=208; PBO, n=103) were included in the study⁵ .
• A total of 275 patients (88%) completed the 52-week treatment period, 184 (88%) of whom were randomized to ICOTYDE. Of the 92 patients randomized to PBO who transitioned to ICOTYDE at week 16, 91 (99%) completed the 52-week treatment period.⁵
• Overall, 200 patients (64%) were male and 243 (78%) were White. The mean (standard deviation) age was 44.7 (14.3) years (6 patients [2%] were ≥12 to <18 years old).^1,5
• In the ICOTYDE and PBO groups, respectively, 41% and 54% of patients had nail PsO at baseline (mNAPSI score >0), with mean baseline mNAPSI scores of 24.4 for ICOTYDE and 14.6 for PBO.²

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 percentage points; 95% confidence interval [CI], 42.1-58.8; P<0.001).¹
• Percent improvement in mean NAPSI score from baseline through week 52 is presented in Figure: Mean mNAPSI^a Improvement from Baseline through Week 52.
• Among the 85 ICOTYDE-treated patients with a baseline mNAPSI score of >0, the mean percent improvement in NAPSI score was 33.2% at week 16 and 62.0% at week 52.
• Complete clearance of nail psoriasis (mNAPSI 0) at week 52 was achieved by more than one-third of patients.⁵

Overall Safety

• Through week 16, adverse events (AEs; ≥5% of patients in any group) were nasopharyngitis (ICOTYDE, 12%; PBO, 11%), upper respiratory tract infection (ICOTYDE, 4%; PBO, 5%), and headache (ICOTYDE, 3%; PBO, 6%).⁵
• Through week 52, the ICOTYDE safety profile was comparable with that observed through week 16.
• No new safety signals were identified through week 52. For more details, see Table: AEs in ICONIC-TOTAL through Week 52.^2,5

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.
• 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.
• Select outcome: Mean percent mNAPSI improvement among patients with a baseline score >0.

Results

Patient Characteristics

• At baseline, an mNAPSI score >0 was observed in 43% of patients receiving ICOTYDE (557/1297) and in 47% of those receiving PBO (267/569).³
  • Mean baseline mNAPSI score was 19.8 for the ICOTYDE group and 17.2 for the PBO group.

Efficacy

• ICOTYDE treatment demonstrated progressive improvement in nail PsO, with mean mNAPSI improvement of 35% at week 16 and 50% at week 24.³
  • PBO-randomized patients showed -14% mean mNAPSI improvement at week 16, followed by 26% mean mNAPSI improvement at week 24 after crossover to ICOTYDE.

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 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 08 June 2026.