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ICOTYDE™ (icotrokinra)
Medical Information
ICOTYDE - Treatment of Nail Psoriasis
Last Updated: 03/18/2026
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-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 in the ICONIC-TOTAL and ICONIC-LEAD studies.1
- 6 - In ICONIC-TOTAL, at week 16, patients receiving ICOTYDE had a 33% improvement in modified Nail Psoriasis Severity Index (mNAPSI) from baseline vs 9% in the placebo (PBO) group.3
- 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.1
- In ICONIC-LEAD, at week 16, 50% vs 21% of patients in the ICOTYDE vs PBO group achieved a Physician’s Global Assessment of fingernail (f-PGA) 0/1 response (treatment difference, 30.1%; 95% confidence interval [CI], 16.4-42.0; nominal P<0.001).4
- At week 16, 24% vs 12% of patients in the ICOTYDE vs PBO group achieved an f-PGA 0 response (treatment difference, 11.9%; 95% CI, 0.2-22.0; nominal P<0.05).
- At week 16, patients in the ICOTYDE group vs PBO group showed a 44% vs 2% mean mNAPSI improvement from baseline (treatment difference, 41.3%; 95% CI, 12.8-69.7; nominal P<0.01).
- In ICONIC-TOTAL, at week 16, patients receiving ICOTYDE had a 33% improvement in modified Nail Psoriasis Severity Index (mNAPSI) from baseline vs 9% in the placebo (PBO) group.3
CLINICAL DATA
ICONIC-TOTAL
Gooderham et al (2025)1 and Lain et al (2025)3 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 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 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 16.1
- The primary and select secondary outcome measures are described in Table: Select ICONIC-TOTAL Outcome Measures at Week 16.1,
3
| 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 |
| Percent change from baseline in mNAPSI score. |
| Abbreviations: IGA, Investigator’s Global Assessment; mNAPSI, modified Nail Psoriasis and Severity Index. |
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, 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.3
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% CI, 42.1-58.8; P<0.001).1
- Select endpoints are described in Table: Select ICONIC-TOTAL Endpoints.
3
| ICO (n=78-81) | PBO (n=52-54) | PBO→ICO Crossover (n=46) | |
|---|---|---|---|
| Mean mNAPSI improvement from baselinea | |||
| Week 16 | 33 | 9 | - |
| Week 24 | 48 | - | 42 |
| Week 32 | 53 | - | 48 |
| Week 52 | 62 | - | 59 |
| Abbreviations: ICO, ICOTYDE; mNAPSI, modified Nail Psoriasis and Severity Index; PBO, placebo. aAmong patients with a baseline mNAPSI score >0. | |||
Safety
- Through week 16, 50% (105/208) of patients receiving ICOTYDE and 45% (46/103) of patients receiving PBO reported ≥1 adverse event (AE).3
- 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: AEs in ICONIC-TOTAL Through Week 52).3
- No new safety signals were identified through week 52.3
| 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 |
| Any AE, n (%) | 105 (50) | 46 (45) | 51 (55) | 153 (74) | 204 (68) |
| SAEs, n (%) | 1 (<1) | 2 (2) | 1 (1) | 6 (3) | 7 (2) |
| AEs leading to discontinuation, n (%) | 6 (3) | 4 (4) | 0 | 7 (3) | 7 (2) |
| Infections, n (%) | 59 (28) | 23 (22) | 39 (42) | 106 (51) | 145 (48) |
| Serious infections, n (%) | 0 | 1 (1) | 0 | 0 | 0 |
| Gastrointestinal AEs, n (%) | 15 (7) | 8 (8) | 7 (8) | 21 (10) | 28 (9) |
| Malignancyb | 1 (<1) | 0 | 0 | 2 (1) | 2 (1) |
| Abbreviations: AE, adverse event; ICO, ICOTYDE; PBO, placebo; SAE, serious adverse event; PY, patient-year. 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. | |||||
ICONIC-LEAD
Bissonnette et al (2025)2
Study Design/Methods
- Key inclusion criteria2:
- Age ≥12 years with moderate to severe plaque PsO diagnosed for ≥26 weeks before screening; candidate for phototherapy or systemic therapy
- Total BSA involvement ≥10%
- Psoriasis Area and Severity Index (PASI) score ≥12
- IGA score ≥3
- Patients were randomized (2:1) to receive either oral ICOTYDE 200 mg once daily or PBO, with PBO crossover to ICOTYDE at week 16.2
- Coprimary endpoints: IGA 0/1 response with a ≥2-grade reduction from baseline to week 16 and PASI 90 response at week 16.2
- Select subgroup analysis outcomes: f-PGA 0/1 and f-PGA 0 responses among patients with f-PGA ≥2 at baseline and mNAPSI percent improvement among patients with mNAPSI >0 at baseline.4
Results
Patient Characteristics
- A total of 684 patients (ICOTYDE, n=456; PBO, n=228) were included in the study. Most patients were male (65%) and White (72%), with a mean age of 42.6 years.2
- In the ICOTYDE and PBO groups, respectively, 30% and 29% had a f-PGA score ≥2, 43% and 44% had mNAPSI score >0, and mean baseline mNAPSI scores were 17.7 and 19.1.4
Efficacy – Overall Population
- Coprimary endpoints: At week 16, in the ICOTYDE and PBO groups, respectively, 65% (295/456) and 8% (19/228) of patients achieved an IGA 0/1 response (adjusted treatment difference, 56.4 percentage points; 95% CI, 50.4-61.7; P<0.001). For PASI 90 response at week 16, 50% (226/456) of patients in the ICOTYDE group and 4% (10/228) of patients in the PBO group achieved a response (adjusted treatment difference, 45.1 percentage points; 95% CI, 39.5-50.4; P<0.001).2
Efficacy - High-Impact Site Involvement Subgroup Analysis
- The results of a subgroup analysis evaluating ICOTYDE in patients aged ≥12 years with plaque PsO and high-impact site involvement (nail) are described in Table: ICONIC-LEAD Subgroup Analysis – Select High-Impact Site Response Rates.4
| ICO | PBO | Treatment Difference, % (95% CI) | |
|---|---|---|---|
| Proportion of patients achieving endpointa, % | (n=137) | (n=66) | |
| f-PGA 0/1, % | |||
| Week 16 | 50 | 21 | Nominal P<0.001c |
| Week 24 | 64 | - | - |
| f-PGA 0, % | |||
| Week 16 | 24 | 12 | Nominal P<0.05c |
| Week 24 | 29 | - | - |
| mNAPSId | (n=187) | (n=98) | |
| Week 16 | 44 | 2 | 41.3 (12.8-69.7)e Nominal P<0.01c |
| Abbreviations: CI, confidence interval; CMH, Cochran-Mantel-Haenszel; f-PGA, Physician’s Global Assessment of fingernail; ICO, ICOTYDE; LSM, least squares mean; MMRM, mixed-effect model repeated measure; mNAPSI, modified Nail Psoriasis Severity Index; PBO, placebo. aAmong patients with a baseline f-PGA score ≥2. bTreatment difference and 95% CI (using Miettinen-Nurminen method) were calculated adjusting for age group and baseline weight category for adults using Mantel-Haenszel weights. cP-values were based on CMH chi-square test stratified by age group and baseline weight category for adults. These endpoints were not adjusted for multiple comparisons. Therefore, the P-values displayed are nominal, and statistical significance has not been established. dAmong patients with a baseline mNAPSI score >0. eLSM, LSM difference, and P-value were based on the MMRM model with treatment group, visit, treatment group by visit interaction, age group, baseline weight, geographic region, baseline mNAPSI total score, and baseline mNAPSI total score by visit interaction as covariates. | |||
Safety – Overall Population
- Through week 16, 50% and 49% of patients in the ICOTYDE and PBO groups, respectively, reported ≥1 AE, with nasopharyngitis and upper respiratory tract infections being the most common.5
- Through week 16, 23% (107/456) and 22% (51/228) of patients in the ICOTYDE and PBO groups, respectively, reported an infection.2
- The ICOTYDE AE profile through week 52 was consistent with that observed through week 16 (see Table: AEs in the Overall ICONIC-LEAD Population Through Week 52).2,5,6
| Variable, n (%) | PBO-Controlled (Adults and Adolescents) | Active Treatment (Adults and Adolescents) | ICO Responders Re-randomized at Week 24 (Adults) | |||
|---|---|---|---|---|---|---|
| Weeks 0-16 | Weeks 16-52 | Weeks 0-52 | Weeks 24-52 | |||
| ICO (n=456) | PBO (n=228) | ICOa (n=213) | ICO (n=456) | ICO→ICO (n=168) | ICO→PBOb (n=172) | |
| Follow-up duration, weeks, mean | 15.9 | 15.8 | 35.3 | 43.4 | 27.7 | 27.8 |
| Any AE | 226 (50) | 112 (49) | 132 (62) | 313 (69) | 92 (55) | 82 (48) |
| Most common AEs (≥5%) | ||||||
| Nasopharyngitis | 31 (7) | 15 (7) | 23 (11) | 64 (14) | 21 (12) | 20 (12) |
| URTI | 30 (7) | 16 (7) | 24 (11) | 52 (11) | 9 (5) | 15 (9) |
| SAEc | 6 (1) | 6 (3) | 4 (2) | 16 (4) | 3 (2) | 5 (3) |
| Serious infection | 1 (<1) | 0 | 1 (<1) | 1 (<1) | 0 | 1 (1) |
| AE leading to discontinuationd | 6 (1) | 1 (<1) | 4 (2) | 10 (2) | 1 (1) | 3 (2) |
| Gastrointestinal AEe | 26 (6) | 13 (6) | 9 (4) | 51 (11) | 7 (4) | 8 (5) |
| Active tuberculosis | 0 | 0 | 0 | 0 | 0 | 0 |
| Malignancyf | 2 (<1) | 0 | 0 | 2 (<1) | 0 | 0 |
| Abbreviations: AE, adverse event; ICO, ICOTYDE; PBO, placebo; SAE, serious adverse event; URTI, upper respiratory tract infection. aIncludes data after week 16 for PBO-randomized patients who crossed over to receive ICO. bCombined withdrawal and retreatment group. cSAEs through week 16 included acute cholecystitis, concussion, craniofacial fracture, pelvic fracture, worsening psoriasis, and hypertensive urgency in the PBO group and adenocarcinoma of the colon, prostate cancer, pancreatitis, bacterial gastroenteritis, arthralgia, and subarachnoid hemorrhage in the ICO group. dAEs leading to discontinuation through week 16 included blood glucose increase in the PBO group and adenocarcinoma of the colon, prostate cancer, hypertriglyceridemia, subarachnoid hemorrhage, erectile dysfunction, and psoriasis in the ICO group. eBased on gastrointestinal disorders system organ class. fIncluded adenocarcinoma of the colon (1 patient who had a history of smoking; the patient reported mild gastroenteritis during screening, severe colitis starting on study day 7, and severe ileus on day 14 leading up to the diagnosis of grade 3 adenocarcinoma of the colon on day 19) and prostate cancer (1 patient who had a history of smoking and a family history of prostate cancer; this patient had an elevated prostate-specific antigen level before baseline and received a diagnosis of grade 1 prostate cancer on study day 48). | ||||||
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). |
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