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SUMMARY
- The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
- ICOTYDE in combination with biologics has not been studied in patients with plaque psoriasis.
- Exclusion criteria related to concomitant therapy in the ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE-2 phase 3 trials is listed below.1-3
CLINICAL TRIAL PROTOCOLS
Exclusion Criteria
Prior or Concomitant Therapy
- Previously received ICOTYDE.
- Previously received deucravacitinib.1-3
- Experienced primary efficacy failure (no response within 16 weeks) to 1 or more agents directly targeting interleukin (IL)-23 or has had a clinically significant adverse event to 1 or more agents directly targeting IL-23.1-3
- Prohibited medications or class of medications are provided in Table: Select Prohibited Medications in Phase 3 Clinical Trials.
Select Prohibited Medications in Phase 3 Clinical Trials1-3
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|
|---|
Any biologic therapy, including but not limited to:
| 12 weeks or 5 half-lives, whichever was longer, prior to the first administration of study intervention (through end of study)
|
IL-23 inhibitors: guselkumab, tildrakizumab, risankizumab
|
IL-17 inhibitors: secukinumab, brodalumab, ixekizumab
|
IL-12/23 inhibitors: ustekinumab, briakinumab
|
TNF-α antagonists: adalimumab, infliximab, etanercept, certolizumab, golimumab
|
Natalizumab
|
Belimumab
|
Abatacept
|
Visilizumab
|
Experimental or investigational therapy
|
Abbreviations: IL, interleukin; TNF, tumor necrosis factor.
|
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 04 February 2026.
| 1 | Bissonnette R, Soung J, Hebert AA, et al. Protocol to: Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393(18):1784-1795. |
| 2 | Gooderham M, Lain E, Bissonnette R, et al. Protocol to: Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12). |
| 3 | Gold LS, Armstrong AW, Bissonnette R, et al. Supplement to: Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomised, placebo-controlled and active-comparator-controlled trials. Lancet. 2025;406(10510):1363-1374. |