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ICOTYDE™ (icotrokinra)
Medical Information
ICOTYDE - Treatment of Hand and Foot Psoriasis
Last Updated: 06/26/2026
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
- 5 - 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,
4 - At week 16, 25% and 13% of patients in the ICOTYDE and PBO groups, respectively, achieved an hf‑PGA score of 0.
- In the ICOTYDE group, the hf-PGA 0/1 response rate at week 52 was 62%.2
- 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
- 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,
CLINICAL DATA
ICONIC-TOTAL
Warren et al (2026),2 Gooderham et al (2025),1 and Lain et al (2025)4 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 (DB), PBO-controlled study.
Study Design/Methods
- Key inclusion criteria1,2:
- Adults (≥18 years) and adolescents (≥12 to <18 years) 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 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 and active treatment through week 156.1,2
- The primary and select secondary outcome measures are described in Table: Select ICONIC-TOTAL Outcome Measures at Week 16.
| Primary Endpoint |
|---|
| Percentage of patients who achieved an IGA score of clear (0) or minimal (1) and a ≥2-grade improvement from baseline |
| Select Secondary Endpoints |
| Percentage of patients who achieved an hf-PGA score of clear (0) or almost clear (1) |
| Abbreviations: hf-PGA, Physician’s Global Assessment of Hands and/or Feet; IGA, Investigator’s Global Assessment. |
Patient Characteristics
- A total of 311 patients (ICOTYDE, n=208; PBO, n=103) were included in the study.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
- At baseline, severe disease (hf-PGA score=4) was observed in 35% (n=17) of ICOTYDE-treated patients and 17% (n=4) of PBO-treated patients.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%; 95% CI, 42.1-58.8; P<0.001).1
- hf-PGA 0/1 response rates are presented in Figure: hf-PGA 0/1 Response Rates through Week 52.
- Among 20 patients randomized to ICOTYDE who achieved an hf-PGA 0/1 response at week 16, 100% maintained the response at week 52.
- Other select endpoints are described in Table: Complete Clearance Data in Hand/Foot PsO in ICONIC-TOTAL through Week 52.
Abbreviations: CI, confidence interval; ICO, ICOTYDE; PBO, placebo; PsO, psoriasis; hf-PGA, Physician’s Global Assessment of Hands and/or Feet.
a
Note: Week 52 data are exploratory. The same patients may not have responded at each time point.
Nonresponder imputation was applied for missing data. Patients discontinuing the study drug due to lack of efficacy, worsening PsO, or use of a protocolprohibited medication or therapy with potential to improve PsO before week 52 were classified as nonresponders after discontinuation. In the PBO group, only patients who crossed over to ICOTYDE were included in analyses after week 16.
| ICO (n=48) | PBO (n=23) | PBO→ICO Crossovera (n=19) | |
|---|---|---|---|
| Proportion of patients achieving endpoint, % | |||
| hf-PGA 0b | |||
| Week 16 | 25 | 13 | - |
| Week 52 | 58 | - | 58 |
| Abbreviations: hf-PGA, Physician’s Global Assessment of Hands and/or Feet; ICO, ICOTYDE; PBO, placebo. Note: Week 52 data are exploratory. aPatients crossed over from PBO→ICO at week 16. bAmong patients with a baseline hf-PGA score ≥3. | |||
Overall Safety
- Through week 16, the most common 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%).2
- 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: Overall AEs in ICONIC-TOTAL through Week 52.2,4
| Weeks 0-16 | Weeks 16-52 | Through Week 52 | |||
|---|---|---|---|---|---|
| ICO (n=208) | PBO (n=103) | PBO→ICO (n=92) | ICO (n=208) | ICO Combineda (n=300) | |
| Mean weeks of follow-up | 16 | 15.6 | 36.2 | 49.3 | 45.3 |
| PYs of follow up | 63.6 | 30.8 | 63.9 | 196.4 | 260.2 |
| ≥1 AE, n (%) | 105 (50.5) | 46 (44.7) | 51 (55.4) | 153 (73.6) | 204 (68.0) |
| Patients/100 PYs (95% CI)b | 232.8 (188.2-277.3) | 217.0 (154.3-279.7) | 132.0 (95.8-168.3) | 168.5 (141.8-195.2) | 157.6 (136.0-179.3) |
| ≥1 SAE, n (%) | 1 (0.5) | 2 (1.9) | 1 (1.1) | 6 (2.9) | 7 (2.3) |
| Patients/100 PYs (95% CI)b | 1.6 (0-4.7) | 6.6 (0-15.7) | 1.6 (0-4.7) | 3.1 (0.6-5.6) | 2.7 (0.7-4.8) |
| AEs leading to discontinuation, n (%) | 6 (2.9) | 4 (3.9) | 0 | 7 (3.4) | 7 (2.3) |
| Patients/100 PYs (95% CI)c | 9.6 (3.5-20.8) | 13.2 (3.6-33.7) | 0 (0-4.7) | 3.6 (1.4-7.4) | 2.7 (1.1-5.6) |
| ≥1 infection, n (%) | 59 (28.4) | 23 (22.3) | 39 (42.4) | 106 (51.0) | 145 (48.3) |
| Patients/100 PYs (95% CI)b | 110.0 (81.9-138.1) | 88.3 (52.2-124.4) | 80.9 (55.5-106.3) | 81.1 (65.6-96.5) | 81.0 (67.8-94.2) |
| ≥1 serious infection, n (%) | 0 | 1 (1.0) | 0 | 0 | 0 |
| Patients/100 PYs (95% CI)c | 0 (0-4.7) | 3.3 (0.1-18.1) | 0 (0-4.7) | 0 (0-1.5) | 0 (0-1.2) |
| ≥1 gastrointestinal AE, n (%) | 15 (7.2) | 8 (7.8) | 7 (7.6) | 21 (10.1) | 28 (9.3) |
| Patients/100 PYs (95% CI)b | 24.8 (12.3-37.4) | 27.0 (8.3-45.6) | 11.5 (3.0-20.0) | 11.6 (6.6-16.6) | 11.6 (7.3-15.9) |
| ≥1 malignancy,d | 1 (0.5) | 0 | 0 | 2 (1.0) | 2 (0.7) |
| Patients/100 PYs (95% CI)c | 1.6 (0-8.8) | 0 (0-9.7) | 0 (0-4.7) | 1.0 (0.1-3.7) | 0.8 (0.1-2.8) |
| Abbreviations: AE, adverse event; CI, confidence interval; ICO, ICOTYDE; PBO, placebo; PY, patient years; SAE, serious adverse event. aIncludes data for ICO-randomized patients through week 52 and for PBO→ICO patients from week 16 through week 52. bCIs were derived using a Wald statistic based on a normal assumption. cCIs were derived using an exact method with an assumption thet the observed number of events followed a Poisson distribution. dMalignancy includes chronic lymphocytic leukemia and malignant melanoma in situ. | |||||
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 16.3,5
- 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 outcomes: hf-PGA 0/1 and hf-PGA 0 response rates through week 24 among patients with hf-PGA score ≥3 at baseline.
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 score, 3) was reported in 80% vs 82%, and severe hand/foot PsO (hf‑PGA score, 4) in 20% vs 18% of patients receiving ICOTYDE vs PBO, respectively. See Table: Baseline Characteristics of Patients with an hf-PGA score ≥3.
| ICO (n=319) | PBO (n=124) | |
|---|---|---|
| Demographics | ||
| Age, years, mean (SD) | 47.3 (14.2) | 48.0 (13.6) |
| Female, n (%) | 100 (31) | 38 (31) |
| Race, % | ||
| Asian/Black/White | 22/2/76 | 22/3/72 |
| BMI, kg/m2, mean (SD) | 29.7 (6.6)a | 30.2 (7.4)a |
| Disease Characteristics | ||
| PsO duration, years, mean (SD) | 16.7 (12.1) | 16.4 (13.1) |
| % of BSA with PsO, mean (SD) | 27.4 (17.7) | 27.3 (17.5) |
| IGA score, % | ||
| Moderate (3)/Severe (4) | 69/31 | 70/30 |
| PASI (0-72), mean (SD) | 20.7 (8.9) | 20.4 (9.4) |
| Prior PsO Treatments, % | ||
| Phototherapy(PUVA and UVB) | 33 | 28 |
| Systemic therapyᵇ | 67 | 68 |
| Biologic therapyᶜ | 26 | 40 |
| Abbreviations: BMI, body mass index; BSA, body surface area; hf-PGA, Physician’s Global Assessment of Hands and/or Feet; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis; PUVA, psoralen plus ultraviolet A; SD, standard deviation; UVB, ultraviolet B. aICO, n=318; PBO, n=123. bConventional nonbiologic systemics, novel nonbiologic systemics, 1,25-vitamin D3 and analogs, phototherapy, and biologics. cAdalimumab, alefacept, briakinumab, brodalumab, certolizumab pegol, efalizumab, etanercept, guselkumab, infliximab, ixekizumab, natalizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab. | ||
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.
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.
| ICO (n=1068) | PBO (n=460) | |
|---|---|---|
| Follow-up duration, weeks, mean | 15.9 | 15.6 |
| Any AE, n (%) | 516 (48) | 233 (51) |
| Serious AE, n (%) | 15 (1) | 9 (2) |
| AE leading to discontinuation, n (%) | 21 (2) | 15 (3) |
| Infection, n (%) | 252 (24) | 114 (25) |
| Serious infection, % | 0 | 1 (<1) |
| Malignancy, n (%) | 5 (<1) | 1 (<1) |
| Abbreviations: AE, adverse event; hf-PGA, Physician’s Global Assessment of Hands and/or Feet; ICO, ICOTYDE; PBO, placebo; PsO, psoriasis; sPGA-G, static Physician’s Global Assessment of Genitalia; ss-IGA, scalp‑specific Investigator’s Global Assessment. Note: Safety analysis set includes all randomized and treated patients. aPooled phase 3 cohort with at least moderate PsO (ss-IGA, sPGA-G, and/or hf-PGA score ≥3) at ≥1 high-impact site. | ||
LITERATURE SEARCH
A literature search of MEDLINE®
References
| 1 | Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12):EVIDoa2500155. |
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