Trial reportAdvances in therapy2023
Pharmacokinetics, Safety, and Efficacy of Ixekizumab in Chinese Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 1, Single- and Multiple-Dose Study.
Trial report in Advances in therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03073213 (A Phase 1, Single- and Multiple-Dose Study to Assess the Safety and Pharmacokinetics of Ixekizumab), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1, Single- and Multiple-Dose Study to Assess the Safety and Pharmacokinetics of Ixekizumab (LY2439821) (Anti-IL-17 Humanized Antibody) in Chinese Patients With Psoriasis Vulgaris
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.
- Comparative efficacy and safety of IL-17 and IL-23 inhibitors for moderate-to-severe psoriasis in Asian populations: a systematic review and meta-analysis.BMC immunology · 2026Pooled it
- Efficacy and Safety of Xeligekimab Compared to Other IL-17A Inhibitors for Chinese Patients with Moderate-to-severe Plaque Psoriasis: A Matching-adjusted Indirect Comparisons.Acta dermato-venereologica · 2026Trial
- Pharmacokinetics, Safety, and Immunogenicity of Intravenous and Subcutaneous Single-Dose QX002N Injection in Healthy Subjects: A Randomized, Open, Parallel, Single-Center, Phase I Study.Rheumatology and therapy · 2024Article
- Inter-Antibody Variability in the Clinical Pharmacokinetics of Monoclonal Antibodies Characterized Using Population Physiologically Based Pharmacokinetic Modeling.Antibodies (Basel, Switzerland) · 2024Article
Corrections and comments
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Authors and funding
11 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionWe evaluated the pharmacokinetics (PK), safety, and efficacy of ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, in Chinese patients with moderate-to-severe psoriasis.
methodsIn this phase 1, multicenter, open-label study, adults (≥ 18 years) diagnosed with moderate-to-severe plaque psoriasis for ≥ 6 months involving ≥ 10% of their body surface area received ixekizumab 80 mg by subcutaneous injection and were observed for 20 weeks (single-dose phase) and then an initial dose of 160 mg followed by randomization (1:1) to 80 mg ixekizumab every 2 weeks (IXE Q2W) or every 4 weeks (IXE Q4W) for an 8-week treatment period (multiple-dose phase).
resultsThe median time to maximum observed ixekizumab concentrations occurred 2-4 days after dosing and the geometric mean half-life was 15-16 days, after single (n = 12) and multiple (n = 29) doses. Approximately linear pharmacokinetics were observed between the 80 and 160 mg single doses. Steady-state systemic exposure to ixekizumab during a dosing interval was similar with the IXE Q2W and IXE Q4W regimens, with estimates of 224 µg·day/mL and 213 µg·day/mL for the area under the concentration-time curve from time 0 to 14 days post-dose and 0 to 28 days post-dose, respectively. Safety was consistent with the established safety profile of ixekizumab. At week 12 after multiple doses, the proportions of patients achieving a 75% or 90% improvement in Psoriasis Area and Severity Index score were 100% and 86% for IXE Q2W, respectively, and 93% and 80% for IXE Q4W, respectively. A Static Physician's Global Assessment score of 0 or 1 was achieved in 100% and 87% with IXE Q2W and IXE Q4W, respectively.
conclusionsThe PK of ixekizumab in Chinese patients with moderate-to-severe plaque psoriasis was comparable to findings in global populations. After IXE Q2W or IXE Q4W for 12 weeks, clinically relevant treatment responses and an acceptable safety profile were observed.
trial registrationClinicaltrials.gov (NCT03073213).
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