The objective of this study is to explore the efficacy and safety of gevokizumab in patients with Schnitzler syndrome.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Exploratory descriptive endpoints on efficacy and safety.
Secondary outcome
not applicable
Background summary
The purpose of this study is to assess the efficacy and safety of a new drug
called gevokizumab in treating Schnitzler syndrome. The Schnitzler syndrome is
a rare chronic inflammatory disease characterised by recurrent urticarial rash
of the skin, recurrent fever, bone or arthritis pain and high levels of certain
proteins in the blood called immunoglobulins. The present study will assess if
the tested drug can improve the Schnitzler syndrome by reducing the
inflammatory agents involved in the development of the disease.
Study objective
The objective of this study is to explore the efficacy and safety of
gevokizumab in patients with Schnitzler syndrome.
Study design
This is a phase II exploratory, single-centre, open-label, proof of concept
study .
Intervention
Subcutaneous injection of gevokizumab.
Study burden and risks
cfr E2 and E9
Internationalelaan 57
Brussel 1070
BE
Internationalelaan 57
Brussel 1070
BE
Listed location countries
Age
Inclusion criteria
- Male or female, aged >= 18 years
- Weight >= 45 kg and <= 125 kg
- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures, and for female subjects a negative serum pregnancy test
- Probable or definite Schnitzler syndrome according to Strasbourg criteria.
Exclusion criteria
- Differential diagnoses other than Schnitzler syndrome,
- Any prior treatment with systemic alkylating agents within the previous 6 months prior to selection,
- Active TB disease,
- History of severe allergic or anaphylactic reactions to monoclonal antibodies,
- History of malignancy within 5 years prior to selection,
- Known immunodeficiency,
- Infectious disease,
- Any live (attenuated) vaccine within 3 months prior to selection,
- Pregnancy, breastfeeding or possibility to become pregnant during the study
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 |
|---|---|
| Other | EU clinical trials register (https : // www.clinicaltrialsregister.eu)via eudract form |
| EudraCT | EUCTR2013-002562-39-NL |
| CCMO | NL45331.091.13 |