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ICOTYDE™

(icotrokinra)

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ICOTYDE™ (icotrokinra)
Medical Information

ICOTYDE - Acceptability and Palatability Among Adolescents

Last Updated: 09/08/2026

SUMMARY

  • The company cannot recommend any practices, procedures, or usage of ICOTYDE that deviate from the approved labeling.
  • ICONIC-LEAD is an ongoing, phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled study (NCT06095115) evaluating the efficacy and safety of oral ICOTYDE in patients ≥12 years of age with moderate to severe plaque psoriasis (PsO).1
    • Most adolescents who received ICOTYDE reported the tablets as “easy” to swallow at both week 0 and week 16.2
    • At week 16, the overall acceptability and palatability of ICOTYDE was reported as "acceptable" (61%) or "good" (39%) in all adolescents receiving ICOTYDE.2

CLINICAL DATA

ICONIC-LEAD: Adolescent Subgroup

ICONIC-LEAD is a phase 3 clinical trial evaluating the efficacy and safety of oral ICOTYDE for the treatment of patients ≥12 years of age with moderate to severe plaque PsO.1

Study Design/Methods

  • Key, relevant inclusion criteria1,3:
    • Aged 12 to <18 years
    • Plaque PsO for ≥26 weeks
    • Body surface area (BSA) ≥10%, Psoriasis Area and Severity Index (PASI) score ≥12, Investigator’s Global Assessment (IGA) score ≥3
    • Candidate for phototherapy or systemic therapy for plaque PsO
    • Body weight ≥40 kg
  • Adolescent patients were randomized (2:1) to receive oral ICOTYDE 200 mg once daily or PBO, with PBO crossover to ICOTYDE at week 16.1,3 
  • Data on acceptability and palatability of ICOTYDE was collected from adolescents.2 

Results


Acceptability and Palatability of ICOTYDE Among Adolescent Patients through Week 162
ICOTYDE
PBO
Week 0
N=43
Week 16
N=41
Week 0
N=22
Week 16
N=21
Sweetness, %
    None
84
76
96
71
    Weak
16
22
5
24
    Moderate
0
2
0
5
    Strong
0
0
0
0
Bitterness, %
    None
74
76
86
62
    Weak
19
10
5
29
    Moderate
7
15
9
5
    Strong
0
0
0
5
Swallowability, %
    Very easy
56
44
36
29
    Moderately easy
14
22
32
29
    Slightly easy
9
10
0
5
    Neither difficult nor easy
12
17
14
14
    Slightly difficult
2
2
18
0
    Moderately difficult
2
0
0
14
    Very difficult
5
5
0
10
Overall, %
    Good
40
39
46
38
    Acceptable
56
61
50
43
    Almost acceptable
5
0
5
19
    Bad
0
0
0
0
Abbreviations: PBO, placebo.Note: ICOTYDE was provided as a 200 mg film-coated tablet for oral administration. The matching PBO was identical to the ICOTYDE tablets except there was no active ingredient in the PBO formulation.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 7 May 2026.

 

References

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1 Janssen Research & Development, LLC. A study of JNJ-77242113 in adolescent and adult participants with moderate to severe plaque psoriasis (ICONIC-LEAD). ln: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 April 13]. Available from: https://clinicaltrials.gov/study/NCT06095115 NLM Identifier: NCT06095115.  
2 Data on File. Icotrokinra. Clinical Study Report 77242113PSO3001. Janssen Research & Development, LLC. EDMS-RIM-1306643, v1.0; 2025.  
3 Soung J, Lebwohl MG, Hebert A, et al. Durability of icotrokinra (targeted oral peptide) effects in adolescents with moderate-to-severe plaque psoriasis: one-year results from the ICONIC-LEAD study. Posters presented at: AAD Annual Meeting; March 27-31, 2026; Denver, Colorado, USA.  

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