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ICOTYDE™ (icotrokinra)
Medical Information
ICOTYDE - Treatment of Scalp Psoriasis
Last Updated: 03/19/2026
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 ICONIC-LEAD, 72% vs 15% of patients in the ICOTYDE vs PBO groups, respectively, achieved ss-IGA 0/1 response at week 16 (treatment difference, 57%; 95% CI, 49.9–63.1; P<0.001).2
- In ICONIC-ADVANCE 1, 72% vs 21% of patients in the ICOTYDE vs PBO groups, respectively, achieved ss-IGA 0/1 response at week 16 (treatment difference, 51%; 95% CI, 42-59; P<0.001).3
, 4 - In ICONIC-ADVANCE 2, 74% vs 18% of patients in the ICOTYDE vs PBO groups, respectively, achieved ss-IGA 0/1 response at week 16 (treatment difference, 56%; 95% CI, 44-65; P<0.001).3,4
- 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
Gooderham et al (2025)1 and Lain et al (2025)5
Study Design/Methods
- Key inclusion criteria:1
- 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 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 16.1 - The primary and select secondary outcome measures are described in Table: Select ICONIC-TOTAL Outcome Measures at Week 16.1
| 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 ≥4-point improvement from baseline in Scalp Itch NRS score |
| Abbreviations: 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, with 64% being male and 78% being White. The mean age was 45 years (6 patients were ≥12 and <18 years old).1
- 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
- Select secondary endpoints are described in Table: Select ICONIC-TOTAL Endpoints.
1,5
| 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 0/1b | ||||
| Week 16 | 66 | 11 | 56% (44.8-64.4) P<0.001c | - |
| Week 52 | 72 | - | - | 71 |
| ss-IGA 0b | ||||
| Week 16 | 49 | 2 | Nominal P<0.001c,d | - |
| Week 52 | 57 | - | - | 61 |
| PSSI 90b | ||||
| Week 16 | 58 | 6 | 52% (41.7-60.3) P=0.008c | - |
| CMI in Scalp Itch NRSe | ||||
| Week 16 | 59 | 9 | 50% (37.8-60.6) P=0.008c | - |
| 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 ≥3cP-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 | ||||
Safety
- Through week 16, 50% (105/208) of patients receiving ICOTYDE and 45% (46/103) of patients receiving PBO reported ≥1 adverse events (AE).5
- 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).5
- No new safety signals were identified through week 52.5
| PBO-Controlled | Crossover | Active Comparator | |||
|---|---|---|---|---|---|
| ICO N=208 | PBO N=103 | PBO→ICO N=92 | ICO N=208 | ICO Combineda N=300 | |
| Treatment period | W0-16 | W16-52 | W0-52 | ||
| Mean weeks of follow-up | 16 | 16 | 36 | 49 | 45 |
| 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) |
| Malignancy, n (%)b | 1 (<1) | 0 | 0 | 2 (1) | 2 (1) |
| Abbreviations: AE, adverse event; ICO, ICOTYDE; PBO, placebo; SAE, serious adverse event; W, week. aIncludes data for ICO-randomized patients through week 52 and for PBO-to-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 and Soung et al (2025)6
Study Design/Methods
- Key inclusion criteria:2
- Age ≥12 years with moderate to severe plaque PsO diagnosed for ≥26 weeks at screening; candidate for phototherapy or systemic therapy
- Total BSA involvement ≥10%
- Total PASI score ≥12
- IGA score ≥3
- Patients were randomized (2:1) to receive oral ICOTYDE 200 mg or PBO once daily, with PBO crossover to ICOTYDE at week 16.2
- Coprimary endpoints: IGA 0/1 with a ≥2-grade improvement from baseline to week 16 and PASI 90 at week 16.2
- Select key secondary endpoint: ss-IGA 0/1 with a ≥2-grade improvement from baseline, assessed among those with baseline ss-IGA score ≥2.2
Results
Patient Characteristics
- A total of 684 (ICOTYDE, n=456; PBO, n=228) patients were included in the study, with 65% being male, 72% being White, and a mean age of 43 years.2
- In the ICOTYDE group, 59% (268/451) and 17% (76/451) of patients had moderate or severe scalp PsO, respectively; while 51% (116/227) and 22% (49/227) of patients in the PBO group had moderate or severe scalp PsO, respectively.2
Efficacy – Overall Population
- The coprimary and relevant key secondary endpoints are described in Table: Select ICONIC-LEAD Endpoints.
| ICO N=456 | PBO N=228 | Treatment Difference (95% CI) | |
|---|---|---|---|
| Proportion of patients achieving endpoint, n (%) | |||
| IGA 0/1 with a ≥2-grade improvement from baseline | |||
| Week 16 – coprimary endpoint | 295 (65) | 19 (8) | 56% (50.4-61.7) P<0.001a |
| PASI 90 | |||
| Week 16 – coprimary endpoint | 226 (50) | 10 (4) | 45% (39.5-50.4) P<0.001a |
| ss-IGA 0/1 and ≥2-grade improvement from baselineb | |||
| Week 16 | 293/405 (72) | 30/200 (15) | 57% (49.9–63.1) P<0.001a |
| Abbreviations: CI, confidence interval; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area Severity Index; PBO, placebo; QD, daily; ss-IGA, scalp-specific Investigator’s Global Assessment. aP-values were calculated based on Cochran-Mantel-Haenszel chi-square test stratified by age group, baseline weight category (adults only), and geographic region (if applicable). P-values for key secondary endpoints were adjusted for multiplicity. bAmong patients with baseline ss-IGA score ≥2. | |||
Efficacy – High-Impact Site Involvement Subgroup Analysis
- The results of a subgroup analysis evaluating ICOTYDE in patients ≥12 years of age with plaque PsO and high-impact site involvement (scalp) are described in Table: ICONIC-LEAD Subgroup Analysis – Select High-Impact Site Response Rates.6
| ICO N=344 | PBO N=165 | Treatment Difference (95% CI) | ||
|---|---|---|---|---|
| Proportion of patients achieving endpoint, % | ||||
| ss-IGA 0/1a | ||||
| Week 16 | 72 | 14 | 58% (50.8-64.8)b Nominal P<0.001c | |
| Week 24 | 81 | - | - | |
| ss-IGA 0a | ||||
| Week 16 | 53 | 9 | 44% (36.5-50.1)b Nominal P<0.001c | |
| Week 24 | 65 | - | - | |
| Abbreviations: CI, confidence interval; CMH, Cochran-Mantel-Haenszel; ICO, ICOTYDE; PBO, placebo; ss-IGA, scalp-specific Investigator’s Global Assessment. aAmong patients with a baseline ss-IGA score ≥3. bTreatment difference and 95% CI (using Miettinen-Nurminen method) were calculated adjusting for age group, baseline weight category for adults, and geographic region using Mantel-Haenszel weights.cP-values were based on CMH test stratified by age group, baseline weight category for adults, and geographic region. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal, and statistical significance has not been established. | ||||
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 infection being the most common.7
- 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: Adverse Events in the Overall ICONIC-LEAD Population through Week 52).2,7,8
| PBO-Controlled (Adults & Adolescents) | Active Treatment (Adults & Adolescents) | ICO Responders Re-Randomized at W24 (Adults) | ||||
|---|---|---|---|---|---|---|
| ICO N=456 | PBO N=228 | ICOa N=213 | ICO N=456 | ICO→ICO N=168 | ICO→PBOb N=172 | |
| Treatment period | W0-16 | W16-52 | W0-52 | W24-52 | ||
| Mean weeks of follow-up | 16 | 16 | 35 | 43 | 28 | 28 |
| 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 events; ICO, ICOTYDE; PBO, placebo; SAEs, serious adverse events; URTI, upper respiratory tract infection; W, week.Note: Data are n (%), unless otherwise specified 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, 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; grade 1 prostate cancer was diagnosed on study day 48). | ||||||
ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2
Stein Gold et al (2025)3 reported results through week 24 from ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, two phase 3, multicenter, randomized, double-blind clinical trials evaluating the efficacy and safety of oral ICOTYDE 200 mg once daily compared to PBO and deucravacitinib for the treatment of adults with moderate to severe plaque PsO.
Study Design/Methods
- Both studies employed identical enrollment criteria.3
- Key inclusion criteria: age ≥18 years with moderate to severe plaque PsO diagnosed for ≥26 weeks at screening who were candidates for phototherapy or systemic therapy; total BSA involvement ≥10%, total PASI score ≥12, and IGA score ≥3.
- Patients were randomized to oral ICOTYDE 200 mg once daily, PBO, or oral deucravacitinib 6 mg, with PBO crossover to ICOTYDE at week 16 and deucravacitinib crossover to ICOTYDE at week 24. ADVANCE 1 and ADVANCE 2 utilized different randomization ratios (2:1:2 and 4:1:4, respectively).3
- Coprimary endpoints: IGA 0/1 with a ≥2-grade improvement from baseline to week 16 and PASI 90 at week 16 (ICOTYDE group versus PBO group).3
- Select key secondary endpoint: ss-IGA 0/1 with a ≥2-grade improvement from baseline, assessed among those with baseline ss-IGA score ≥2 (ICOTYDE group versus PBO group).3
Results
Patient Characteristics
- A total of 774 and 731 patients were randomized to ADVANCE 1 (ICOTYDE n=311; PBO n=156; deucravacitinib n=307) and ADVANCE 2 (ICOTYDE n=322; PBO n=82; deucravacitinib n=327), respectively.3
- Across ADVANCE 1 and ADVANCE 2, most patients were male (68% and 68%, respectively) and White (74% and 83%, respectively). The mean age at baseline was 46.7 and 46.1 years in ADVANCE 1 and ADVANCE 2, respectively.3
- In the ICOTYDE groups, 57% and 52% of patients had moderate scalp PsO in ADVANCE 1 and ADVANCE 2, respectively, while 13% and 12% had severe scalp PsO. In the PBO groups, 54% and 59% of patients had moderate scalp PsO in ADVANCE 1 and ADVANCE 2, respectively, while 12% and 7% had severe scalp PsO.3
Efficacy
- The primary and select key secondary endpoints are described below:3,4
- In the deucravacitinib groups, ss-IGA 0/1 at week 16 was achieved by 57% and 64% of patients in ICONIC-ADVANCE 1 (n=268) and ICONIC-ADVANCE 2 (n=278), respectively.3
| n (%) | ICO N=311 | PBO N=156 | Treatment Difference (95% CI) | Adjusted P-value |
|---|---|---|---|---|
| Primary Endpoints | ||||
| IGA 0/1 | 213 (68) | 17 (11) | 58 (50-64) | P<0.0001 |
| PASI 90 | 171 (55) | 6 (4) | 51 (44-57) | P<0.0001 |
| Key Secondary Endpoints | ||||
| ss-IGA 0/1a | 189 (72) | 28 (21) | 51 (42-59) | P<0.001 |
| Abbreviations: CI, confidence interval; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area Severity Index; PBO, placebo; ss-IGA, scalp-specific Investigator’s Global Assessment. aAmong the 261 and 134 patients with a baseline ss-IGA score ≥2 in the ICO and PBO groups, respectively. | ||||
| n (%) | ICO N=322 | PBO N=82 | Treatment Difference (95% CI) | Adjusted P-value |
|---|---|---|---|---|
| Primary Endpoints | ||||
| IGA 0/1 | 227 (70) | 7 (9) | 62% (53, 69) | P<0.0001 |
| PASI 90 | 184 (57) | 1 (1) | 56% (48, 62) | P<0.0001 |
| Key Secondary Endpoints | ||||
| ss-IGA 0/1a | 199 (74) | 13 (18) | 56% (44, 65) | P<0.001 |
| Abbreviations: CI, confidence interval; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area Severity Index; PBO, placebo; ss-IGA, scalp-specific Investigator’s Global Assessment. aAmong the 270 and 71 patients with a baseline ss-IGA score ≥2 in the ICO and PBO groups, respectively. | ||||
A total of 632, 237, and 634 patients in the ICOTYDE, PBO, and deucravacitinib groups were included in the combined safety analysis set.3 - Through week 16, 48% (303/632), 57% (136/237), and 57% (360/634) of patients receiving ICOTYDE, PBO, and deucravacitinib, respectively, reported ≥1 AE(s).3
- The most common AEs were nasopharyngitis, upper respiratory tract infection, and headache.
- Gastrointestinal AEs occurred in 7% (45/632), 6% (15/237), and 10% (63/634) of patients in the ICOTYDE, PBO, and deucravacitinib groups, respectively.
- Through week 24, AE rates were lower in the ICOTYDE group versus the deucravacitinib group (57% vs 65%), and no safety signals were identified.3
- See Table: Combined AEs from the ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 Safety Analysis Sets.
Combined AEs from the ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 Safety Analysis Sets3
| PBO-Controlled | Active Comparator-Controlled | Crossover | ||||
|---|---|---|---|---|---|---|
| ICO | PBO | Deucra | ICO | Deucra | PBO→ICO | |
| Number of patientsa | 632 | 237 | 634 | 632 | 634 | 215 |
| Treatment period | W0-16 | W0-24 | W16-24 | |||
| Mean weeks of follow up (SD) | 16 (1.88) | 16 (2.69) | 16 (2.25) | 24 (3.26) | 23 (3.94) | 8 (0.58) |
| ≥1 AE, n (%) | 303 (48) | 136 (57) | 360 (57) | 359 (57) | 411 (65) | 60 (28) |
| AEs occurring in ≥5% of patients in any treatment group, n (%) | ||||||
| Headache | 26 (4) | 11 (5) | 19 (3) | 28 (4) | 20 (3) | 3 (1) |
| Nasopharyngitis | 37 (6) | 13 (5) | 58 (9) | 56 (9) | 77 (12) | 8 (4) |
| URTI | 23 (4) | 8 (3) | 33 (5) | 32 (5) | 49 (8) | 7 (3) |
| Serious AE, n (%) | 14 (2) | 4 (2) | 14 (2) | 18 (3) | 20 (3) | 3 (1) |
| Serious infectionb | 1 (<1) | 1 (<1) | 4 (1) | 3 (<1) | 4 (1) | 0 |
| AE resulting in discontinuation, n (%) | 13 (2) | 12 (5) | 14 (2) | 15 (2) | 17 (3) | 0 |
| GI AEs, n (%) | 45 (7) | 15 (6) | 63 (10) | 55 (9) | 80 (13) | 5 (2) |
| Malignancy, n (%)c | 3 (<1) | 1 (<1) | 1 (<1) | 3 (<1) | 2 (<1) | 0 |
| Active TB, n (%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Abbreviations: AE, adverse events; Deucra, deucravacitinib; GI, gastrointestinal; ICO, ICOTYDE; PBO, placebo; SD, standard deviation; TB, tuberculosis; URTI, upper respiratory tract infection; W, week. aThe safety analysis set included all randomized and treated participants.bSerious infections included bacterial arthritis (PBO group), campylobacter colitis (Deucra group), viral infection (Deucra group), infection exacerbated by chronic obstructive airways disease (ICO group), lower respiratory tract infection (Deucra group), viral upper respiratory tract infection (Deucra group), and pneumonia (ICO group).cDetails on malignancies reported through Week 24 of both studies are provided as early as Week 4.4 | ||||||
- Through week 24, there were 6 instances of malignancy reported across ICONIC-ADVANCE 1 and ICONIC-ADVANCE 24:
- Three in the ICOTYDE group (pancreatic carcinoma, breast cancer, and keratoacanthoma)
- One in the PBO group (invasive ductal breast carcinoma)
- Two in the deucravacitinib group (right buccal squamous cell carcinoma and malignant melanoma in situ)
- All events were considered unrelated to study treatments by investigators.
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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