ArticleClinical pharmacokinetics2022
Assessment of the Pharmacokinetics and Safety of Spesolimab, a Humanised Anti-interleukin-36 Receptor Monoclonal Antibody, in Healthy Non-Japanese and Japanese Subjects: Results from Phase I Clinical Studies.
Article in Clinical pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 5 papers.
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.
Single-blind, Partially Randomised, Placebo-controlled Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Intravenous Doses of BI 655130 in Healthy Male Volunteers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 655130 (Double-blind, Partially Randomised Within Dose Groups, Placebo-controlled Parallel Group Design) and One Single Intravenous Dose of BI 655130 (Single-blind, Partially Randomised, Placebo-controlled) in Healthy Male Subjects
Safety, Tolerability, and Pharmacokinetics of Two Dose Strengths of a Single Subcutaneous Dose of BI 655130 and One Single Intravenous Dose of BI 655130 in Healthy Male and Female Subjects (Open-label, Parallel Group Design)
Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Dose and Single Subcutaneous Dose of BI 655130 in Healthy Japanese Male Volunteers (Double-blind, Randomised, Placebo-controlled Design).
Relative Bioavailability, Safety, and Tolerability Following Subcutaneous Injection of Different Doses of BI 655130 and Different Injection Sites in Healthy Male and Female Subjects (a Single Dose, Mono-centric, Open-label Study in Matched-group Design).
Who cites it
5 citing papers in PubMed, 11 citations in OpenAlex.
- Lack of Differences in the Pharmacokinetics of Therapeutic Monoclonal Antibodies Between Japanese and Non-Japanese Individuals.Journal of clinical pharmacology · 2026Review
- Genotype-Phenotype Correlations and Clinical Outcomes of Spesolimab in Acrodermatitis Continua of Hallopeau: A Multicenter Retrospective Cohort Study.Psoriasis (Auckland, N.Z.) · 2026Article
- Pharmacokinetics and Safety of Spesolimab in Healthy Chinese Subjects: An Open-Label, Phase I Study.Advances in therapy · 2024Article
- Spesolimab for generalized pustular psoriasis: a review of two key clinical trials supporting initial US regulatory approval.Frontiers in immunology · 2024Review
- A Phase 1 Open-Label Study to Assess the Tolerability, Safety, and Immunogenicity of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 20% in Healthy Adults.Journal of clinical immunology · 2023Article
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveThe interleukin-36 signalling pathway is associated with pathogenesis of a number of inflammatory diseases. Spesolimab is a selective, humanised, IgG1 antibody that targets the interleukin-36 receptor. We aimed to evaluate the pharmacokinetics, safety and tolerability of single and multiple doses of spesolimab in healthy non-Japanese and Japanese subjects.
methodsFive phase I clinical studies (three placebo-controlled dose-escalation, two open-label) were conducted in healthy volunteers; single or multiple doses of spesolimab were administered by intravenous infusion or subcutaneous injection. Plasma samples were collected to investigate the pharmacokinetics of spesolimab and evaluate changes with respect to dose, frequency of dosing, formulation and injection site. Immunogenicity, safety and tolerability were also assessed.
resultsIntravenous spesolimab exhibited target-mediated drug disposition at low doses (0.01-0.3 mg/kg) and linear kinetics at doses ≥ 0.3 mg/kg. Steady state was not attained after the fourth weekly dose because of the long half-life (3-5 weeks). Bioavailability of subcutaneous spesolimab increased with increasing dose over the range of 150-600 mg and was higher when administered to the thigh than to the abdomen. The pharmacokinetic profile was consistent between Japanese and non-Japanese subjects. Positive anti-drug antibody responses occurred during the terminal phase of the spesolimab concentration-time profile in 26.7-33.3% and 16.7-37.5% of subjects receiving intravenous and subcutaneous spesolimab, respectively. The impact of anti-drug antibodies on spesolimab pharmacokinetics was low in healthy volunteers, with the impact on spesolimab plasma concentrations only observed in a few subjects at higher titres (≥ 11,400). No serious adverse events were reported; intravenous doses up to 1200 mg were well tolerated in healthy volunteers.
conclusionsThe pharmacokinetic profile and safety data obtained from these phase I clinical studies have been used to guide spesolimab dosing in clinical studies of patients with interleukin-36-mediated diseases. CLINICAL
trial registrationFor Studies 1-5, NCT02525679, NCT02852824, NCT03100903, NCT03123094, NCT03617835.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.