This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
company core data sheet
Drug Interactions
- No formal drug-drug interaction studies have been conducted with ICOTYDE.1
- Based on in vitro studies, icotrokinra is not a CYP enzyme substrate, inhibitor, or inducer. Icotrokinra is not a substrate or inhibitor of P-glycoprotein (P-gp) or other major drug transporters. Therefore, no clinically relevant drug interactions have been identified.1
CLINICAL TRIAL PROTOCOLS
Bissonnette et al (2025)2, Gooderham et al (2025)3, and Stein Gold et al (2025)4 included the following protocol language for ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2.
Prior and Concomitant Therapy
- Thyroid medications were not prohibited during the ICONIC phase 3 trials.2-4
- Modification of an effective pre-existing therapy was not made for the explicit purpose of entering a patient into the studies.2-4
Concomitant Medications
- Review of concomitant therapies was completed at every study visit during the screening period (weeks -5 to 0); at weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 44, and 52; and at any unscheduled visit per the investigator’s discretion.2-4
CLINICAL Data
ICONIC-ADVANCE 1, ICONIC-ADVANCE 2, ICONIC-TOTAL, and ICONIC-LEAD
Patients with Concomitant Thyroid Medications (Based on Data through Week 52)5-8
|
|
|---|
|
|
|
|
|---|
Thyroid replacement therapy
| 43 (5.8)
| 45 (6.4)
| 17 (5.6)
| 4 (0.6)
|
Levothyroxine
| 42 (5.7)
| 44 (6.3)a
| 15 (5.0)
| 4 (0.6)
|
Thyroid
| 1 (0.1)
| 1 (0.1)
| -
| -
|
Liothyronine
| -
| -
| 1 (0.3)
| -
|
Levothyroxine/liothyronine
| -
| -
| 1 (0.3)
| -
|
aIncludes levothyroxine sodium/potassium iodide. Note: Values include data after Week 16 for PBO patients who crossed over to receive ICOTYDE. For ADVANCE 1 and ADVANCE 2, values also include data after Week 24 for deucravacitinib patients who switched to receive ICOTYDE. At the time of the data on file reports, the studies were ongoing.
|
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 22 July 2026.
| 1 | Data on File. Icotrokinra. Company Core Data Sheet v002. Janssen Research & Development, LLC. EDMS-RIM-1387700; 2026. |
| 2 | 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. |
| 3 | 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). |
| 4 | Stein Gold L, 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. |
| 5 | Data on File. Icotrokinra. Clinical Study Report 77242113PSO3002. Janssen Research & Development, LLC. EDMS-RIM-1677639, v1.0; 2025. |
| 6 | Data on File. Icotrokinra. Clinical Study Report 77242113PSO3004. Janssen Research & Development, LLC. EDM-RIM-1677696, v1.0; 2025. |
| 7 | Data on File. Icotrokinra. Clinical Study Report 77242113PSO3003. Janssen Research & Development, LLC. EDMS-RIM-1306699, v1.0; 2025. |
| 8 | Data on File. Icotrokinra. Clinical Study Report 77242113PSO3001. Janssen Research & Development, LLC. EDMS-RIM-1306643, v1.0; 2025. |