The main purpose of this study is to investigate the effect of nipocalimab on how quickly and to what extent etanercept or hydroxychloroquine is absorbed, distributed, metabolized and eliminated from the body. The study consists of 2 parts, Part 1…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the effect of nipocalimab on the PK of etanercept in healthy
participants.
To assess the effect of HCQ on total serum IgG reduction of or by nipocalimab
in healthy participants.
Secondary outcome
To assess the safety and tolerability of nipocalimab following coadministration
of etanercept in healthy participants.
To assess the PK of nipocalimab following coadministration of etanercept in
healthy participants.
To assess the immunogenicity of nipocalimab following coadministration of
etanercept in healthy participants.
To assess and compare the PK of nipocalimab with and without coadministration
of HCQ in healthy participants.
To assess the effect of HCQ on nipocalimab PD in healthy participants
Background summary
Nipocalimab is a compound that may potentially be used for the treatment of
autoimmune and inflammatory diseases caused by a specific kind of antibody,
called IgG antibodies. Nipocalimab is an antibody (part of the body*s defense
system that is released due to the presence of foreign substances) that binds
to a protein that is called the neonatal Fc receptor. This Fc receptor can be
found on many cell types of the human body. The neonatal Fc receptor is
involved in transport of IgG antibodies and inhibition of breakdown of these
IgG antibodies. In autoimmune diseases there are *wrong* IgG antibodies that
are involved in the disease process. The compound nipocalimab is able to bind
the neonatal Fc receptor leading to an increased degradation of all IgG
antibodies. It is hoped that this will ultimately lead to the treatment of
autoimmune diseases with *wrong* IgG antibodies.
Study objective
The main purpose of this study is to investigate the effect of nipocalimab on
how quickly and to what extent etanercept or hydroxychloroquine is absorbed,
distributed, metabolized and eliminated from the body.
The study consists of 2 parts, Part 1 and Part 2. The interaction between
nipcalimab and etanercept is investigated in Part 1 and the interaction between
nipocalimab and hydroxychloroquine is investigated in Part 2.
Etanercept and hydroxychloroquine have been chosen because this agent is used
for the treatment of autoimmune diseases. When looking at the effect of
nipocalimab on this agent, something can also be said about whether nipocalimab
can be administered together with this agent in the treatment of autoimmune
diseases. This is important to know when nipocalimab is given in the future
along with this agent.
It will also be investigated how safe nipocalimab is and how well it is
tolerated in the presence of etanercept and hydroxychloroquine.
In addition, we look at the effect of nipocalimab on the body.
Nipocalimab has been used by humans before. In addition, it has been
extensively tested in the laboratory and on animals. Etanercept and
hydroxychloroquine is already available on the market in several dosages and
formulations.
Study design
The examination from the inspection up to and including the follow-up takes a
maximum of 5 months, 11 weeks (Groups 2a/b) or 12 weeks (Groups 2c/d).
Nipocalimab is administered on Days 29, 43 and 57. Etanercept is administered
on Days 1 and 43.
For the research it is necessary that you stay in the research center for 2
periods of 6 days (5 nights) and 2 periods of 2 days (1 night). Period 1 is
from Day -1 to Day 5, Period 2 is from Day 28 to Day 29, Period 3 is from Day
42 to Day 47 and Period 4 is from Day 56 to Day 57.
Groups 2a/b:
Nipocalimab is given on Day 1.
For the research it is necessary to stay in the research center for 1 period of
9 days (8 nights).
Period 1 is from Day -1 to Day 8.
Groups 2c/d:
Nipocalimab is given on Day 8. Hydroxychloroquine is given on Day 1 to Day 22.
For the research it is necessary to stay in the research center for 1 period of
16 days (15 nights).
Nipocalimab is given as an intravenous infusion. Etanercept is given as a
subcutaneous injection. Hydroxychloroquine is given as tablets by mouth with
240 milliliters (ml) of (tap) water with a meal or glass of milk.
Intervention
Day 1 etanercept 50 mg subcutaneous injection once
Day 29 nipocalimab 15 mg/kg once intravenous infusion
Day 43 nipocalimab 15 mg/kg intravenous infusion once and etanercept 50 mg
subcutaneous injection once
Day 57 nipocalimab 15 mg/kg once intravenous infusion
Group 2a/b:
Day 1 nipocalimab 15 mg/kg once intravenous infusion
Group 2c/d
Day 1 to 22 hydroxychloroquine 400 mg once daily tablets by mouth
Day 8 nipocalimab 15 mg/kg once intravenous infusion
Study burden and risks
Blood draw
Blood draws may hurt or cause bruising. Using an indwelling cannula can
sometimes cause inflammation, swelling, hardening of the artery, or blood
clotting and bleeding around the puncture site. In some individuals, a blood
draw can sometimes cause paleness, nausea, sweating, slow heart rate, or drop
in blood pressure with dizziness or fainting.
All in all, we take a maximum of 450 milliliters (ml) of blood. This amount
does not cause any problems in adults.
ECG
To make a heart film, electrodes are placed on the arms, chest and legs.
Prolonged use of these electrodes may cause skin irritation.
Coronavirus test
Samples for the coronavirus test will be taken with cotton swabs at the back of
the nose and throat. Taking the samples only takes a few seconds, but can cause
discomfort and discomfort. Taking a sample from the back of the throat may
result in gagging. When the sample is taken at the back of the nose, one may
experience a stinging sensation and the eyes may water.
Archimedesweg 29
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Archimedesweg 29
Leiden 2333
NL
Listed location countries
Age
Inclusion criteria
- 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
Exclusion criteria
- 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-001656-33-NL |
| CCMO | NL78405.056.21 |