Evidence map›Paper›PMID 33085033›Full record

Trial reportClinical drug investigation2020

Pharmacokinetics and Pharmacodynamics of JNJ-55920839, an Antibody Targeting Interferon α/ω, in Healthy Subjects and Subjects with Mild-to-Moderate Systemic Lupus Erythematosus.

Zhenling Yao, Laura Loggia, Damien Fink, Marc Chevrier, Stanley Marciniak, Amarnath Sharma, Zhenhua Xu

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02609789 (A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Dose Study of JNJ-55920839 in Subjects With Mild to Moderate Systemic Lupus Erythematosus), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT02609789 phase1completednot on this map

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Dose Study of JNJ-55920839 in Subjects With Mild to Moderate Systemic Lupus Erythematosus

TypeinterventionalSponsorJanssen Research & Development, LLCRan2015 to 2018Enrolled72ConditionsSystemic Lupus Erythematosus, HealthyArmsJNJ-55920839, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Interferon Inhibition in SLE: From Bench to Bedside.Mediterranean journal of rheumatology · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Zhenling YaoJanssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.ORCID http://orcid.org/0000-0002-4271-2837
Laura LoggiaJanssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.
Damien FinkJanssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.
Marc ChevrierJanssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.
Stanley MarciniakJanssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.
Amarnath SharmaJanssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.
Zhenhua XuJanssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA. ZXu5@its.jnj.com.
Janssen (United States) · USSpringhouse · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe interferon (IFN) pathway has been correlated with clinical and serological markers of disease activity in patients with systemic lupus erythematosus (SLE).

objectiveThe pharmacokinetics and pharmacodynamics of JNJ-55920839, a fully human immunoglobulin G1κ antibody targeting IFNα/ω, were investigated.

methodsIn a double-blind, first-in-human study, Part A enrolled 48 healthy adults who received a single dose of placebo/JNJ-55920839 between 0.3 and 15 mg/kg intravenous (IV) or at 1 mg/kg subcutaneous (SC). Part B enrolled 26 adults with SLE who received placebo or JNJ-55920839 10 mg/kg IV 6 times biweekly. Pharmacokinetic parameters were calculated by noncompartmental analysis (NCA) and estimated by nonlinear mixed-effects modeling.

resultsJNJ-55920839 pharmacokinetics following a single IV infusion exhibited a biphasic disposition in healthy subjects. Maximum plasma concentration (C

conclusionPharmacokinetic and pharmacodynamic analyses of the data from this study demonstrated that there was biphasic disposition in both healthy subjects and subjects with SLE, CL was faster in subjects with SLE, and increases in total IFNα/ω levels were observed in both healthy subjects and subjects with SLE after treatment with JNJ-55920839, thus further development is supported. The study is registered at ClinicalTrials.gov NCT02609789.

Indexed as

Antibodies, Monoclonal, HumanizedAdministration, IntravenousAdultArea Under CurveBiological AvailabilityDouble-Blind MethodFemaleHealthy VolunteersHumansInfusions, IntravenousInjections, SubcutaneousInterferon-alphaLupus Erythematosus, SystemicMaleMiddle AgedPlacebosAntibodies, Monoclonal, HumanizedInterferon-alphaJNJ-55920839Placebos

Identifiers

PMID33085033
OpenAlexW3093947922

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.