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ICOTYDE™ (icotrokinra)
Medical Information
ICOTYDE - Treatment of Scalp Psoriasis
Last Updated: 06/19/2026
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) was 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 scalp PsO across these studies.
- In ICONIC-TOTAL, 66% vs 11% of patients in the ICOTYDE vs placebo (PBO) groups, respectively, achieved a scalp-specific Investigator’s Global Assessment (ss-IGA) score of 0 or 1 (ss-IGA 0/1, clear or almost clear skin) at week 16 (treatment difference, 56%; 95% confidence interval [CI], 44.8-64.4; P<0.001).1
- In the ICOTYDE group, the ss-IGA 0/1 response rate at week 52 was 72%.2
- In the ICOTYDE group, the ss-IGA 0/1 response rate at week 52 was 72%.2
- In a pooled analysis of these 4 phase 3 trials, ICOTYDE demonstrated higher clearance vs PBO at week 16 (ss-IGA 0/1: 72% vs 16%; ss-IGA 0: 54% vs 9%), and at week 24, response rates were maintained or improved in the ICOTYDE group vs increased in the PBO→ICOTYDE crossover group (ss-IGA 0/1: 79% vs 73%;
ss-IGA 0: 64% vs 46%).3
- In ICONIC-TOTAL, 66% vs 11% of patients in the ICOTYDE vs placebo (PBO) groups, respectively, achieved a scalp-specific Investigator’s Global Assessment (ss-IGA) score of 0 or 1 (ss-IGA 0/1, clear or almost clear skin) at week 16 (treatment difference, 56%; 95% confidence interval [CI], 44.8-64.4; P<0.001).1
CLINICAL DATA
ICONIC-TOTAL
Warren et al (2026),2 Gooderham et al (2025),1 and Lain et al (2025)4
Study Design/Methods
- Key inclusion criteria1,
2: - Adults (≥18 years) and adolescents (≥12 to <18) 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 Investigator’s Global Assessment (IGA) score ≥2
- Involvement of ≥1 high-impact sites with at least moderate severity (ss-IGA score ≥3, static Physician’s Global Assessment of Genitalia [sPGA-G] score ≥3, Physician’s Global Assessment of hands and feet [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 ≥2-grade improvement from baseline |
| Select Secondary Endpoints |
| Percentage of patients who achieved ss-IGA score of absence of disease (0) or very mild disease (1) |
| Percentage of patients who achieved PSSI 90 response |
| Percentage of patients who achieved CMI (≥4-point improvement from baseline) in Scalp Itch NRS score |
| Abbreviations: CMI, clinically meaningful improvement; IGA, Investigator’s Global Assessment; NRS, numeric rating scale; PSSI, Psoriasis Scalp Severity Index; ss-IGA, scalp-specific Investigator’s Global Assessment. |
Patient Characteristics
- A total of 311 patients (ICOTYDE, n=208; PBO, n=103) were included in the study.1
- A total of 275 patients (88%) completed the 52-week treatment period, 184 (88%) of which 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.2
- 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 adolescents).2,5
- In the ICOTYDE and PBO groups, respectively, 80% (167/208) and 83% (85/103) of patients had at least moderate scalp PsO at baseline (ss-IGA score ≥3).1
Efficacy
- Primary endpoint: 57% (118/208) vs 6% (6/103) of patients receiving ICOTYDE vs PBO, respectively, achieved IGA 0/1 response at week 16 (treatment difference, 51% [95% CI, 42.1-58.8]; P< 0.001).1
- ss-IGA 0/1 response rates are presented in Figure: ss-IGA 0/1 Response Rates through Week 52.2
- Other select endpoints are described in Table: Other Select ICONIC-TOTAL Endpoints through Week 52.
- Among 110 patients randomized to ICOTYDE who achieved an ss-IGA 0/1 response at week 16, 88% sustained the response at week 52.2
Abbreviations: ICO, icotrokinra, PBO, placebo, PsO, psoriasis; ss-IGA, scalp-specific Investigator’s Global Assessment.
Note: Week 52 data are exploratory.
aAmong patients with a baseline ss-IGA score≥3.
b
| ICO N=167 | PBO N=85 | Treatment Difference (95% CI) or P-value | PBO→ICO Crossovera N=75 | |
|---|---|---|---|---|
| Proportion of patients achieving endpoint, % | ||||
| ss-IGA 0b | ||||
| Week 16 | 49 | 2 | Nominal P<0.001c,d | - |
| Week 24 | 60 | - | - | 39 |
| Week 52 | 57 | - | - | 61 |
| PSSI 90b | ||||
| Week 16 | 57 | 6 | 52% (41.7-60.3) P=0.008c | - |
| Week 24 | 69 | - | - | 49 |
| Week 52 | 63 | - | - | 69 |
| CMI in Scalp Itch NRSe | ||||
| Week 16 | 59 | 9 | 50% (37.8-60.6) P=0.008c | - |
| Week 24 | 78 | - | - | 72 |
| Week 52 | 74 | - | - | 78 |
| Abbreviations: BSA, body surface area; CI, confidence interval; CMI, clinically meaningful improvement (≥4-point improvement from baseline); ICO, ICOTYDE; IGA, Investigator’s Global Assessment; NRS, numeric rating scale; PBO, placebo; PSSI, Psoriasis Scalp Severity Index; PSSI 90, reduction from baseline of ≥90% in the PSSI score; ss-IGA, scalp-specific Investigator’s Global Assessment. aPatients crossed over from PBO to ICO at week 16. bAmong patients with a baseline ss-IGA score ≥3 cP-values were calculated based on Cochran-Mantel-Haenszel chi-square test stratified by high-impact site involvement (if applicable), geographic region, and/or BSA category (if applicable). d eAmong patients with a baseline Scalp Itch NRS score ≥4 and a ss-IGA score ≥3 (ICO, N=131; PBO, N=58). | ||||
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/total PYs of follow-up | 16.0/63.6 | 15.6/30.8 | 36.2/63.9 | 49.3/196.4 | 45.3/260.2 |
| ≥1 AE, n (%) | 105 (50.5) | 46 (44.7) | 51 (55.4) | 153 (73.6) | 204 (68.0) |
| ≥1 SAE, n (%) | 1 (0.5) | 2 (1.9) | 1 (1.1) | 6 (2.9) | 7 (2.3) |
| AEs leading to discontinuation, n (%) | 6 (2.9) | 4 (3.9) | 0 | 7 (3.4) | 7 (2.3) |
| ≥1 infection, n (%) | 59 (28.4) | 23 (22.3) | 39 (42.4) | 106 (51.0) | 145 (48.3) |
| ≥1 serious infection, n (%) | 0 | 1 (1.0) | 0 | 0 | 0 |
| ≥1 gastrointestinal AE, n (%) | 15 (7.2) | 8 (7.8) | 7 (7.6) | 21 (10.1) | 28 (9.3) |
| ≥1 malignancy,b n (%) | 1 (0.5) | 0 | 0 | 2 (1.0) | 2 (0.7) |
| Abbreviations: AE, adverse event; ICO, ICOTYDE; PBO, placebo; PY, patient-year; SAE, serious adverse event. aIncludes data for ICO-randomized patients through week 52 and for PBO→ICO patients from week 16 through week 52. bMalignancy 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 16.3,6
- 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: ss-IGA 0/1 and ss-IGA 0 response rates through week 24.
Results
Patient Characteristics
- At baseline, 72% of patients in both the ICOTYDE (935/1297) and PBO (408/569) groups had an ss-IGA score ≥3.3
- Moderate scalp PsO (ss-IGA score, 3) was reported in 80% vs 77%, and severe scalp PsO (ss-IGA score, 4) in 20% vs 23% of patients receiving ICOTYDE vs PBO, respectively. See Table: Baseline Characteristics of Patients with an ss-IGA score ≥3.
Baseline Characteristics of Patients
| ICO (n=935) | PBO (n=408) | |
|---|---|---|
| Demographics | ||
| Age, years, mean (SD) | 43.6 (14.9) | 44.1 (14.6) |
| Female, n (%) | 318 (34) | 142 (35) |
| Race, % | ||
| Asian/Black/White | 21/2/75 | 23/1/75 |
| BMI, kg/m2, mean (SD) | 29.3 (6.5)a | 29.3 (7.4)a |
| Disease Characteristics | ||
| PsO duration, years, mean (SD) | 16.7 (12.8) | 16.8 (12.7) |
| % of BSA with PsO, mean (SD) | 23.9 (14.9) | 23.4 (15.0) |
| IGA score, % | ||
| Moderate (3)/Severe (4) | 74/25 | 73/26 |
| PASI (0-72), mean (SD) | 19.3 (7.7) | 19.1 (7.9) |
| Prior PsO Treatments, % | ||
| Phototherapy(PUVA and UVB) | 34 | 31 |
| Systemic therapyᵇ | 73 | 71 |
| Biologic therapyᶜ | 30 | 33 |
| Abbreviations: BMI, body mass index; BSA, body surface area; 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; ss-IGA, scalp-specific Investigator’s Global Assessment; UVB, ultraviolet B. aICO, n=930; PBO, n=405. 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 ss‑IGA score ≥3, 72% of ICOTYDE-treated patients achieved ss‑IGA 0/1 at week 16, compared with 16% receiving PBO. At week 24, 79% of ICOTYDE-treated patients and 73% of PBO→ICOTYDE crossover patients achieved ss‑IGA 0/1.3
- Fifty-four percent of ICOTYDE‑treated patients achieved ss‑IGA 0 at week 16, compared with 9% receiving PBO. At week 24, 64% of ICOTYDE-treated patients and 46% of PBO→ICOTYDE crossover patients achieved ss-IGA 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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