The purpose of this study is to investigate how well a new dosage form of tildrakizumab is tolerated when it is administered to healthy volunteers. Tildrakizumab (also known as Ilumetri) is no new compound; it is already available on the market as a…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the local tolerability of the tildrakizumab 200-mg dose when
administered as a single 200 mg/2 mL SC injection or as two 100 mg/1 mL SC
injections in healthy subjects.
Secondary outcome
To assess the safety of the tildrakizumab 200-mg dose when administered as a
single 200 mg/2 mL SC injection or as two 100 mg/1 mL SC injections in healthy
subjects.
To assess the subjects* preferred method of administration of the tildrakizumab
200-mg treatments (single 2 mL or two 1 mL injections).
Background summary
Tildrakizumab is a compound that is being used for the treatment of psoriasis.
Psoriasis is a chronic skin disease where red, dry, and scaly patches are
present on the skin. These patches are most often found on the elbows, knees,
and head, and can cause severe itching and pain. Tildrakizumab belongs to a
group of medicines called interleukin (IL) inhibitors. These medicines work by
blocking the activity of a protein called IL-23, a substance in the body which
is involved in normal inflammatory and immune responses. In psoriasis, IL-23 is
present at increased levels. By reducing the activity of IL-23, tildrakizumab
reduces the inflammatory processes and thereby the signs and symptoms of
psoriasis.
Study objective
The purpose of this study is to investigate how well a new dosage form of
tildrakizumab is tolerated when it is administered to healthy volunteers.
Tildrakizumab (also known as Ilumetri) is no new compound; it is already
available on the market as a 1 milliliter injection with a fixed dose of 100 mg
tildrakizumab per syringe. Tildrakizumab therefore has been administered to
humans before. It has previously also been extensively tested in the laboratory
and on animals. Patients with more severe psoriasis or patients with higher
body weights may benefit from a higher dose. Therefore, the purpose of this
study is to investigate the tolerability of 200 mg tildrakizumab when it is
given as a 2 milliliter injection.
Study design
The volunteer receives 200 mg of tildrakizumab twice. Tildrakizumab is given
once as 1 injection and once as 2 injections. The test substance will be
administered under the skin (subcutaneously) in the volunteer's arm, thigh, or
abdomen. The treatment will be administered in the morning after eating a
standard breakfast. If the volunteer receives 2 injections, the second
injection will be given immediately after the first.
The order in which the volunteer receives the treatment will be random (will be
determined by drawing lots). Whether the volunteer gets the injection into your
arm, thigh, or abdomen will also be randomly assigned.
• Treatment A: 1 injection of 2 mL, administered in the left or right arm or
thigh, or in the left or right side of the abdomen.
• Treatment B: 2 injections of 1 mL, both administered in different arms or
thighs, or in different sides of the abdomen
Intervention
The volunteer receives 200 mg of tildrakizumab twice. Tildrakizumab is given
once as 1 injection and once as 2 injections. The test substance will be
administered under the skin (subcutaneously) in the volunteer's arm, thigh, or
abdomen. The treatment will be administered in the morning after eating a
standard breakfast. If the volunteer receives 2 injections, the second
injection will be given immediately after the first
Study burden and risks
Tildrakizumab is no new compound and has been administered to humans before. It
has been given to 2190 subjects in previous clinical trials and was found to
effectively improve the signs and symptoms of psoriasis in patients.
Furthermore it was found that tildrakizumab was generally safe and well
tolerated.
The following side effect was most frequently observed (in more than 1 in 10
people):
• Infection of the upper respiratory tract (including nose cold
[nasopharyngitis])
The following side effects were also observed (in less than 1 in 10 people):
• Pain at the injection site
• Headache
• Stomach flu (gastroenteritis), nausea or diarrhea
• Back pain
There is a chance that the body may develop antibodies against tildrakizumab.
This means that, if the volunteer need to be treated with tildrakizumab in the
future, the drug does not work or works less well. However, the chance that
this will happen is very small and there are plenty of alternative drugs
available that are still effective. Moreover, no relationship between the
development of antibodies against Ilumetri and the way the drug works or its
side effects was observed in studies with patients.
The study compound may also have side effects that are still unknown. In
addition to unknown side effect, there is a (small) chance that an allergic
reaction will occur. This can be caused by the study compound or the
excipients.
Ronda General Mitre 151
Barcelona 08022
ES
Ronda General Mitre 151
Barcelona 08022
ES
Listed location countries
Age
Inclusion criteria
1. Men or women must be between 18 and 60 years, inclusive, at screening.
2. Body mass index (BMI) must be between 18.0 and 30.0 kg/m2, inclusive, at
screening.
3. Subjects must be able to understand and comply with the requirements of the
study and communicate with the Investigator.
4. Subjects must give a written, signed, and dated informed consent including
authorization for Use and Release of Health and Research Information in
accordance with institutional and regulatory guidelines before any
study-related activity is performed.
5. Subjects are in good general health on the basis of medical history,
physical examination, clinical laboratory, ECG, and vital signs, as judged by
the Investigator.
For the complete overview see the protocol
Exclusion criteria
1. Any condition that could interfere with delivery of medication or
interpretation of assessments or significantly impair pain perception at any of
the anatomical sites for injection (upper arms, thighs, abdomen).
2. History of or current malignancy (excluding successfully treated basal cell
carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma
with no evidence of recurrence within 5 years or carcinoma in situ of the
cervix that has been adequately treated).
3. History of or current relevant autoimmune diseases (e.g., lupus-like
syndromes).
4. Clinically significant skin allergies or active dermatologic disorders.
5. Hypersensitivity to the active substance or to any of the excipients of the
investigational medicinal product (IMP).
For the complete overview see the protocol
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 | EUCTR2020-000183-37-NL |
| CCMO | NL73105.056.20 |