CIDP04 is a Phase 2A, multicenter, single-arm, open-label study with the primary objective of evaluating the long-term safety and tolerability of rozanolixizumab when administered as weekly subcutaneous (sc) infusion in subjects with CIDP. The…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the study is to assess long-term safety and
tolerability of weekly doses of rozanolixizumab in subjects with CIDP.
Secondary outcome
The secondary objective of the study is to assess long-term clinical efficacy
of weekly doses of rozanolixizumab.
The exploratory objectives of the study are to assess the PD, PK, and
immunological variables in the treatment course with rozanolixizumab and to
assess whether long-term dosing of rozanolixizumab improves PROs.
Background summary
Production of pathogenic auto-antibodies is a major feature of a number of
autoimmune diseases
often associated with a specific pathomechanism. Cellular and humoral immune
mechanisms are
thought to be involved in the pathogenesis of CIDP resulting in inflammatory
lesions in the
spinal roots, proximal nerve trunks, and along the peripheral nerves. The
essential role of the
autoimmune antibodies in mediating this pathology is supported by the
improvement seen after
PLEX and IA. Identification of the specific antigenic target(s) of the
autoimmune antibodies in
CIDP is expanding with recent immunological techniques. Treatments aimed at
reducing the
quantity of circulating IgG auto-antibodies are being used for primary and
secondary therapy of
autoimmune diseases, particularly where corticosteroid-based immune suppression
is not or no
longer effective. The therapeutic approach of these treatments is based on
lowering levels of
pathogenic auto-antibodies, which represents rational and effective treatment
modalities of
autoimmune diseases.
Rozanolixizumab is a humanized IgG4 monoclonal antibody that is being developed
as an
inhibitor of the activity of FcRn. The FcRn recycles IgG and albumin and
transports it
bidirectionally across epithelial barriers. Recent studies have shown that FcRn
rescues both IgG
and albumin from intracellular lysosomal degradation by recycling it from the
sorting endosome
to the cell surface (Anderson et al, 2006). Rozanolixizumab has been
specifically designed to
block IgG binding to FcRn without blocking the binding and recycling of
albumin. By blocking
the activity of FcRn, rozanolixizumab accelerates the catabolism of IgG
antibodies, including
IgG auto-antibodies. The aim is to reduce the concentration of pathogenic IgG
in patients with
autoimmune diseases mediated by the action of IgG auto-antibodies.
Study objective
CIDP04 is a Phase 2A, multicenter, single-arm, open-label study with the
primary objective of evaluating the long-term safety and tolerability of
rozanolixizumab when administered as weekly subcutaneous (sc) infusion in
subjects with CIDP. The secondary objective includes evaluating the long-term
clinical efficacy of weekly doses of rozanolixizumab in the subjects with CIDP.
This open-label study will provide subjects who participated in previous
rozanolixizumab studies (eg, CIDP01) the opportunity to have continued access
to rozanolixizumab.
Study design
The CIDP04 study includes a 24-week Treatment Period followed by an 8 week
Observation Period. For the 24-week Treatment Period, subjects will have weekly
visits (either on site or at home) during which they will be dosed with an sc
infusion of rozanolixizumab, up to 10mg/kg.
Intervention
The CIDP04 study includes a 24-week Treatment Period followed by an 8 week
Observation Period. For the 24-week Treatment Period, subjects will have weekly
visits (either on site or at home) during which they will be dosed with an sc
infusion of rozanolixizumab, up to 10mg/kg. The initial dose will be based on
the dose the subject has received at the completion of the parent study (eg,
CIDP01).
Study burden and risks
The study load includes:
Visits: 29 visites
Blood collection: 16 keer
Urine collection: 16 keer
IMPD infusion (SC): 24 keer
ECG: 16 keer
Physical examinationk: 13 keer
Questionnaires about the ability to perform daily and social activities, and
about signs and symptoms of tuberculosis.
The subject may experience physical or psychological discomfort with the
aforementioned tests, prodcedures and questionnaires. The subject may get side
effects from the study medication.
Allée de la Recherche 60
Brussels 1070
BE
Allée de la Recherche 60
Brussels 1070
BE
Listed location countries
Age
Inclusion criteria
- Subject has completed one of the previous rozanolixizumab study(ies) that
allow access to the present study (e.g. study CIDP01)
- Female subjects of childbearing potential must agree to use a highly
effective method of birth control, during the study and for a period of 2
months after their final dose of investigational medicinal product (IMP)
- Male subjects with a partner of childbearing potential must be willing to use
a condom when sexually active during the study and for 3 months after the final
administration of IMP
Exclusion criteria
- Subject has any medical (acute or chronic illness) or psychiatric condition
that, in the opinion of the investigator, could harm the subject or would
compromise the subject*s ability to participate in this study
- Subject has a clinically relevant active infection (eg, sepsis, pneumonia,
abscess)
- Subject has a known hypersensitivity to any components of rozanolixizumab
- Subject intends to have a live vaccination during the course of the study or
within 7 weeks following the final dose of rozanolixizumab
- Subject has an ongoing serious adverse event (SAE) or a medical condition in
the parent study that the investigator considers to put the subject at a
significantly increased risk of participating in CIDP04
- Subject has any planned elective surgery due to occur during the study dosing
period which in the opinion of the investigator could interfere with study
procedures
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 | EUCTR2018-004392-12-NL |
| ClinicalTrials.gov | NCT04051944 |
| CCMO | NL69688.018.19 |