Clinical Trials

JNJ-77242113 (Icotrokinra) has advanced into multiple clinical trials evaluating its therapeutic potential across a spectrum of immune-mediated inflammatory diseases. Sponsored primarily by Janssen Research & Development, LLC and Janssen Pharmaceutical K.K., these studies encompass Phase 1, Phase 2, and Phase 3 clinical evaluations. Investigational settings involve healthy volunteers as well as patient cohorts diagnosed with plaque psoriasis, psoriatic arthritis, ulcerative colitis, Crohn's disease, generalized pustular psoriasis, and erythrodermic psoriasis. Key trials, including Phase 3 studies such as NCT06095102 and NCT06807424, reflect active or recruiting statuses, whereas Phase 1 and Phase 2 trials like NCT05062200 and NCT06049017 have reached completion.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07196722 RECRUITING
Crohn Disease
Janssen Research & Development, LLC
 2025-10-03 PHASE2; PHASE3
NCT07196748 RECRUITING
Colitis, Ulcerative
Janssen Research & Development, LLC
 2025-10-01 PHASE3
NCT06807424 RECRUITING
Arthritis, Psoriatic
Janssen Research & Development, LLC
 2025-01-09 PHASE3
NCT06878404 ACTIVE_NOT_RECRUITING
Arthritis, Psoriatic
Janssen Research & Development, LLC
 2025-02-21 PHASE3
NCT06934226 ACTIVE_NOT_RECRUITING
Plaque Psoriasis
Janssen Research & Development, LLC
 2025-04-15 PHASE3
NCT06295692 ACTIVE_NOT_RECRUITING
Generalized Pustular Psoriasis; Erythrodermic Psoriasis
Janssen Pharmaceutical K.K.
 2024-02-09 PHASE3
NCT06220604 ACTIVE_NOT_RECRUITING
Plaque Psoriasis
Janssen Research & Development, LLC
 2024-03-09 PHASE3
NCT06049017 COMPLETED
Colitis, Ulcerative
Janssen Research & Development, LLC
 2023-10-09 PHASE2
NCT06143878 ACTIVE_NOT_RECRUITING
Plaque Psoriasis
Janssen Research & Development, LLC
 2024-02-01 PHASE3
NCT06095115 ACTIVE_NOT_RECRUITING
Plaque Psoriasis
Janssen Research & Development, LLC
 2023-10-12 PHASE3
NCT06095102 ACTIVE_NOT_RECRUITING
Plaque Psoriasis
Janssen Research & Development, LLC
 2023-10-12 PHASE3
NCT05364554 COMPLETED
Plaque Psoriasis
Janssen Research & Development, LLC
 2022-06-10 PHASE2
NCT05703841 COMPLETED
Healthy
Janssen Research & Development, LLC
 2023-02-14 PHASE1
NCT05357755 COMPLETED
Plaque Psoriasis
Janssen Research & Development, LLC
 2022-06-13 PHASE2
NCT05223868 COMPLETED
Plaque Psoriasis
Janssen Research & Development, LLC
 2022-02-03 PHASE2
NCT05062200 COMPLETED
Healthy
Janssen Pharmaceutical K.K.
 2021-10-25 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the JNJ-77242113(Icotrokinra) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

JNJ-77242113 functions as an oral, selective antagonist of the interleukin-23 receptor, potently blocking interleukin-23-induced STAT3 phosphorylation in peripheral blood mononuclear cells and suppressing downstream interferon-gamma production in natural killer cells. By dampening this key pro-inflammatory cytokine signaling pathway, the compound attenuates pathogenic cellular responses, offering therapeutic efficacy against chronic inflammatory disorders evaluated in clinical trials, including plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.