This study has been transitioned to CTIS with ID 2024-512345-16-00 check the CTIS register for the current data. The purpose of this BIVV020 Phase 2 study is to determine the preliminary efficacy, safety, and tolerability of BIVV020 in three CIDP…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part A:
SOC-Treated:
• Percentage of participants relapsing after withdrawal of SOC and during the
BIVV020 treatment period (up to Week 24). Relapse will be defined as >=1-point
increase in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT)
disability score.
SOC-Refractory:
• Percentage of participants responding during the BIVV020 treatment period (up
to Week 24). Response will be defined as >=1-point decrease in adjusted INCAT
disability score.
SOC-Naïve:
• Percentage of participants responding during the BIVV020 treatment period (up
to Week 24). Response will be defined as >=1-point decrease in
adjusted INCAT disability score.
Part B:
• Incidence, severity, seriousness, and relatedness of adverse events (AEs)
during the entire BIVV020 treatment period and follow-up period (Day 1 up to
Week 98).
Secondary outcome
Part A:
• Incidence, severity, seriousness, and relatedness of AEs during the treatment
and follow-up period (up to Week 46)
• Incidence and titer of anti-BIVV020 antibodies during the treatment and
follow-up period (up to Week 46)
• Percentage of participants in the SOC-Treated group improving during the
overlap treatment period (up to Week 12). Improvement will be defined as
a >=1 point decrease in adjusted INCAT disability score.
Part B:
• Percentage of participants with lasting efficacy during the treatment
extension period (from Week 24 up to Week 76), ie, relapse-free (SOC-Treated)
or with sustained response (SOC-Refractory and SOC-Naïve), defined as no
increase in adjusted INCAT disability score >=2 points).
• Incidence and titer of anti-BIVV020 antibodies during the entire BIVV020
treatment period and follow-up period (Day 1 up to Week 98).
Background summary
BIVV020 is a humanized monoclonal antibody that binds to and selectively
inhibits the activated form of human serine protease complement component 1, s
subcomponent (C1s). By binding to activated C1s, BIVV020 prevents enzymatic
action of the C1 complex on its substrates, complement factors C4 and C2, and
thereby blocks formation of the C3 convertase. The result of this mechanism is
inhibition of complement classical pathway (CP) activity proximal in the
complement activation pathway to C3 which allows the alternative and lectin
pathways to remain functionally intact for the purpose of host defense. The CP
has been implicated in many diseases that are driven by the presence of a
pathogenic antibody; chronic inflammatory demyelinating neuropathy is one such
example.
Study objective
This study has been transitioned to CTIS with ID 2024-512345-16-00 check the CTIS register for the current data.
The purpose of this BIVV020 Phase 2 study is to determine the preliminary
efficacy, safety, and tolerability of BIVV020 in three CIDP subpopulations
including standard of care (SOC)-Treated, SOC-Refractory, and SOC-Naïve.
Study design
This study is a global multicenter, Phase 2, open label, proof-of-concept
study. The study will consist of two parts: an initial 24-week treatment period
(Part A), followed by an optional extension period aimed at evaluating
long-term safety and tolerability (Part B) that will provide up to 1 year of
additional treatment.
Intervention
- Part A: Dosing will begin on Day 1 with a single IV loading dose of 50 mg/kg,
followed by 600 mg weekly subcutaneous injections from Week 2 to Week 24.
- Part B: Dosing will continue as 600 mg weekly subcutaneous injections from
Week 25 to Week 76.
Study burden and risks
Risks related to blood sampling and side effects of the study drug.
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Listed location countries
Age
Inclusion criteria
- Adults >=18 years of age at the time of signing the informed consent.
- Documented definite or probable diagnosis of CIDP (typical CIDP, pure motor
CIDP, or Lewis-Sumner Syndrome) according to the European Federation of
Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) Task Force first
revision.
- Belonging to one of the following three groups: standard-of-care
(SOC)-Treated, SOC-Refractory or SOC-Naïve, as defined in the protocol.
- Documented vaccinations against encapsulated bacterial pathogens given within
5 years of enrollment or initiated a minimum of 14 days prior to first dose as
specified in Section 6.8.1 of the protocol.
- Adherence to contraceptive requirements as detailed in the protocol for men
and women.
- Capable of giving signed informed consent which includes compliance with the
requirements and
restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
- Polyneuropathy of other causes.
- Any other neurological or systemic disease that can cause symptoms and signs
interfering with treatment or outcome assessments.
- Poorly controlled diabetes (HbA1c >7%).
- Serious infections requiring hospitalization within 30 days prior to
screening and any active infection requiring treatment during screening.
- Clinical diagnosis of SLE.
- Treatment with plasma exchange within 12 weeks prior to screening.
- Prior treatment with rituximab or ocrelizumab in the 6 months prior to
BIVV020 dosing or until return of B-cell counts to normal levels, whichever is
longer.
- Immunosuppressive/chemotherapeutic medications within 6 months prior to
dosing (except for some cases as indicated in the SOC-Refractory group).
- Treatment (any time) with highly immunosuppressive/chemotherapeutic
medications with sustained effects.
- Treatment (any time) with total lymphoid irradiation or bone marrow
transplantation.
- Use of any specific complement system inhibitor (eg, eculizumab) within 12
weeks or 5 times the half-life of the product, whichever is longer, prior to
screening.
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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 |
|---|---|
| EU-CTR | CTIS2024-512345-16-00 |
| EudraCT | EUCTR2020-004006-54-NL |
| Other | IND152453 |
| CCMO | NL76114.018.21 |