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HealthyPhase 1NCT04973566

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

A Phase 1 study testing Nipocalimab, Etanercept and Hydroxychloroquine in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Nipocalimab, Etanercept and Hydroxychloroquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteNetherlands
Study dates
31 Aug 2021to 27 May 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRA Health Sciences

    Groningen, NZ 9728

Other trials in Netherlands

About this study

Official title: A Phase 1, Open-Label Study to Investigate Drug-Drug Interaction (DDI) Potential of Nipocalimab With Coadministration of Etanercept or Hydroxychloroquine in Healthy Participants

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
Being tested
Nipocalimab, Etanercept, Hydroxychloroquine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NipocalimabDrug

    Also called JNJ-80202135, M281

    Nipocalimab will be administered as an IV infusion.

  • EtanerceptDrug

    Etanercept will be administered subcutaneously.

  • HydroxychloroquineDrug

    HCQ will be administered orally.

Study groups in NCT04973566
Study groupRoleWhat they receive
Part 1: Etanercept and NipocalimabExperimentalParticipants 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.
Receives: Drug: Nipocalimab; Drug: Etanercept
Part 2 (Cohort 1): NipocalimabExperimentalParticipants will receive a single IV infusion of nipocalimab on Day 1 in Cohort 1 of Part 2.
Receives: Drug: Nipocalimab
Part 2 (Cohort 2): Nipocalimab and Hydroxychloroquine (HCQ)ExperimentalParticipants 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.
Receives: Drug: Nipocalimab; Drug: Hydroxychloroquine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Serum Etanercept Concentration

    Serum etanercept concentration will be reported.

    Measured: Up to Day 99

  2. 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.

    Measured: Up to Day 99

  3. 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.

    Measured: Up to Day 99

  4. 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.

    Measured: Up to Day 99

  5. Part 1: Maximum Observed Concentration (Cmax) of Etanercept

    Cmax is defined as maximum observed concentration of etanercept.

    Measured: Up to Day 99

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

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

    Measured: Up to Day 99

  7. 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.

    Measured: Up to Day 99

  8. 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.

    Measured: Up to Day 99

  9. 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).

    Measured: Up to Day 99

  10. 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).

    Measured: Up to Day 99

  11. 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).

    Measured: Up to Day 99

  12. 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.

    Measured: Baseline up to Day 50

Secondary outcomes (18)

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

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Measured: Up to 4 months

  2. Part 1: Number of Participants with Abnormalities in Physical Examinations

    Number of participants with abnormalities in physical examinations (full and brief) will be reported. Full physical examinations will include a review of the following body systems: general appearance; thorough skin and oral mucosa evaluation; eyes, ears, nose, and throat; cardiovascular; respiratory; abdomen; peripheral pulsation; lymph nodes; neurologic; musculoskeletal; head, neck, and thyroid. A brief physical examination includes review of the following body systems: general appearance, thorough skin (including site of the injection) and oral mucosa, abdomen, respiratory, cardiovascular, any abnormalities noted on previous examinations.

    Measured: Up to 4 months

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

    Number of participants with abnormalities in vital sign measurements (body temperature [temporal artery measurement], pulse/heart rate, respiratory rate, blood pressure) will be reported.

    Measured: Up to 4 months

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

    Number of participants with abnormalities in clinical laboratory tests (serum chemistry, liver panel, hematology, and urinalysis) will be reported.

    Measured: Up to 4 months

  5. Parts 1 and 2: Serum Nipocalimab Concentrations

    Serum nipocalimab concentrations will be reported.

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

  6. Part 1: AUCR of Nipocalimab

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

    Measured: Up to Day 99

  7. Parts 1 and 2: AUC (0-Last) of Nipocalimab

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

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

  8. Parts 1 and 2: AUC (0-Infinity) of Nipocalimab

    AUC (0-Infinity) is defined as area under the concentration-time curve of nipocalimab 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 nipocalimab 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.

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

  9. Parts 1 and 2: Cmax of Nipocalimab

    Cmax is defined as maximum observed concentration of nipocalimab.

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

  10. Part 1: CmaxR of Nipocalimab

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

    Measured: Up to Day 99

  11. Parts 1 and 2: Tlast of Nipocalimab

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

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

  12. Parts 1 and 2: Tmax of Nipocalimab

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

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

  13. Parts 1 and 2: t1/2 of Nipocalimab

    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).

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

  14. Parts 1 and 2: Total Systemic Clearance of Nipocalimab (CL)

    CL is defined as total systemic clearance of nipocalimab following an intravenous (IV) administration, calculated as dose/AUC (0-infinity).

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

  15. Parts 1 and 2: Volume of Distribution (Vdz) of Nipocalimab

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

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

  16. Part 1: Number of Participants with Antibodies to Nipocalimab

    Number of participants with antibodies to nipocalimab will be reported.

    Measured: Up to Day 99

  17. Part 2: Serum Lipid and Albumin Levels

    Participants serum lipid and albumin levels will be reported.

    Measured: Up to Day 50

  18. Part 2: Number of Participants with Receptor Occupancy (RO) Levels of Nipocalimab

    Number of Participants with RO levels (example, neonatal Fc receptor [FcRn] RO in circulating monocytes) of nipocalimab will be reported.

    Measured: Up to Day 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2021
  2. Study start31 Aug 2021
  3. Primary completion27 May 2022
  4. Study completion27 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part 1 is a single-sequence, 2-period study and Part 2 is a randomized, 2-cohort (Cohort 1 and Cohort 2), parallel study.
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04973566
Sponsor's protocol ID
CR109053
Other IDs
2021-001656-33, 80202135EDI1003
Status last verified
Mar 2025
First submitted
13 Jul 2021
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nipocalimab, Etanercept and Hydroxychloroquine in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Serum Etanercept Concentration (time frame: Up to Day 99). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04973566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.

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