A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants

NCT04973566 | Completed Phase 1

• 3 other identifiers: CR1090532021-001656-3380202135EDI1003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to assess the effect of nipocalimab on the pharmacokinetic (PK) of etanercept (Part 1); and to assess the effect of hydroxychloroquine (HCQ) on total serum immunoglobin G (IgG) reduction by nipocalimab (Part 2) in healthy participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

• Part 1: Serum Etanercept Concentration

  Serum etanercept concentration will be reported.

  Up to Day 99

• Part 1: Ratio of Area Under the Concentration-time Curve (AUCR) of Etanercept

  AUCR is defined as the ratio of area under the concentration-time curve.

  Up to Day 99

• Part 1: Area Under the Concentration-time Curve of Etanercept from Time Zero to Time of Last Observed Quantifiable Concentration (AUC [0-Last])

  AUC (0-last) is defined as area under the concentration-time curve of etanercept from time zero to time of last observed quantifiable concentration.

  Up to Day 99

• Part 1: Area Under the Concentration-time Curve of Etanercept from Time Zero to Infinite time (AUC [0-Infinity])

  AUC (0-Infinity) is defined as area under the concentration-time curve of etanercept from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z) where AUC (0-last) is area under the concentration-time curve of etanercept from time zero to time of last observed quantifiable concentration and C(last) is the last observed quantifiable concentration, and lambda(z) is apparent terminal elimination rate constant.

  Up to Day 99

• Part 1: Maximum Observed Concentration (Cmax) of Etanercept

  Cmax is defined as maximum observed concentration of etanercept.

  Up to Day 99

• Part 1: Ratio of Maximum Observed Concentration (CmaxR) of Etanercept

  CmaxR is defined as ratio of maximum observed concentration of etanercept.

  Up to Day 99

• Part 1: Time to Reach the Last Observed Measurable Analyte Concentration (Tlast) of Etanercept

  Tlast is defined as time to reach the last observed measurable analyte concentration of etanercept.

  Up to Day 99

• Part 1: Time to Reach the Maximum Observed Concentration (Tmax) of Etanercept

  Tmax is defined as time to reach the maximum observed concentration of etanercept.

  Up to Day 99

• Part 1: Elimination Half-life (t1/2) of Etanercept

  t1/2 is defined as elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve, calculated as 0.693/ lambda(z).

  Up to Day 99

• Part 1: Total Apparent Clearance (CL/F) of Etanercept

  CL/F is total apparent clearance of etanercept following subcutaneous (SC) administration, calculated as dose/AUC (0-infinity).

  Up to Day 99

• Part 1: Apparent Volume of Distribution (Vdz/F) of Etanercept

  Vdz/F is defined as apparent volume of distribution based on the terminal phase after an SC dose, calculated as dose/lambda(z)\*AUC(0-infinity).

  Up to Day 99

• Part 2: Change from Baseline in Total Serum Immunoglobulin (Ig) Levels

  Change from baseline in total serum Ig levels (serum IgG and IgG subtypes) through Day 50 will be reported.

  Baseline up to Day 50

Secondary Outcomes (18)

• Part 1: Number of Participants with Adverse Events (AEs)

  Up to 4 months

• Part 1: Number of Participants with Abnormalities in Physical Examinations

  Up to 4 months

• Part 1: Number of Participants with Abnormalities in Vital Sign Measurements

  Up to 4 months

• Part 1: Number of Participants with Abnormalities in Clinical Laboratory Tests

  Up to 4 months

• Parts 1 and 2: Serum Nipocalimab Concentrations

  Up to Day 99 (Part 1); up to Day 50 (Part 2)

Study Arms (3)

Part 1: Etanercept and Nipocalimab

EXPERIMENTAL

Participants will receive a single subcutaneous (SC) dose of etanercept on Day 1 in Period 1 followed by single intravenous (IV) infusion of nipocalimab on Day 29, SC administration of etanercept followed by an IV infusion of nipocalimab on Day 43 and then a single dose of nipocalimab IV infusion on Day 57 in Period 2 of Part 1. There will be a wash-out period of 28 days between Day 1 of Period 1 and Day 29 of Period 2 in Part 1.

Drug: Nipocalimab; Drug: Etanercept

Part 2 (Cohort 1): Nipocalimab

EXPERIMENTAL

Participants will receive a single IV infusion of nipocalimab on Day 1 in Cohort 1 of Part 2.

Drug: Nipocalimab

Part 2 (Cohort 2): Nipocalimab and Hydroxychloroquine (HCQ)

EXPERIMENTAL

Participants will receive a single oral dose of HCQ film-coated tablets once daily from Day 1 to Day 22 and a single IV infusion of nipocalimab on Day 8 in Cohort 2 of Part 2.

Drug: Nipocalimab; Drug: Hydroxychloroquine

Interventions

Nipocalimab DRUG

Nipocalimab will be administered as an IV infusion.

Also known as: JNJ-80202135, M281

Part 1: Etanercept and Nipocalimab; Part 2 (Cohort 1): Nipocalimab; Part 2 (Cohort 2): Nipocalimab and Hydroxychloroquine (HCQ)

Etanercept DRUG

Etanercept will be administered subcutaneously.

Part 1: Etanercept and Nipocalimab

Hydroxychloroquine DRUG

HCQ will be administered orally.

Part 2 (Cohort 2): Nipocalimab and Hydroxychloroquine (HCQ)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be consistent with the underlying illness in the study population or considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
• Healthy on the basis of clinical laboratory tests performed at screening (including immunoglobulin \[Ig\]G) and at admission to the study site. If the results of the serum chemistry panel, liver panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
• Good venous access in both arms
• Participants must have heart rate of at least 50 beats per minute
• Participant is considered eligible according to the following tuberculosis (TB) screening criteria (for Part 1 only): a) have no history of latent or active TB before screening; b) have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; c) have had no recent close contact with a person with active TB; d) have a negative QuantiFERON-TB test result within 28 days prior to the administration of study intervention
• Part 1: Body mass index (BMI) greater than or equal to (\>=) 18.0 to less than or equal to (\<=) 30.0 kilogram (kg)/meter (m)\^2 (inclusive), and body weight \>= 50 to \<= 110.0 kg (inclusive) at the screening visit and on Day -1; Part 2: BMI \>= 18.0 to \<= 30.0 kg/m\^2 (inclusive), and body weight \>= 61.5 to \<= 110.0 kg (inclusive) at the screening visit and on Day -1
• A female participant must have a negative serum (beta-human chorionic gonadotropin) test at screening and a urine pregnancy test at Day -1 prior to administration of study intervention
• It is recommended that participants are up to date on age-appropriate vaccinations prior to screening per routine local medical guidelines. For study participants who received locally-approved (and including emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccines recently prior to study entry, applicable local vaccine labeling, guidelines, and standards of care for participants receiving immune-targeted therapy should be followed when determining an appropriate interval between vaccination and study enrollment

You may not qualify if:

• Has a history of liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Has a history of retinal and macular disease (only for Part 2)
• Has shown a previous severe immediate hypersensitivity reaction response, including anaphylaxis, to therapeutic proteins (example, monoclonal antibody \[mAbs\])
• Has serum albumin levels \< 30 grams/Liter (g/L) at screening and Day -1
• Has a history of myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks prior to screening

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

PRA Health Sciences

Groningen, NZ 9728, Netherlands

Location

MeSH Terms

Interventions

Etanercept; Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 is a single-sequence, 2-period study and Part 2 is a randomized, 2-cohort (Cohort 1 and Cohort 2), parallel study.

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: August 31, 2021
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)