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An exploratory study of gevokizumab treatment in patients with Schnitzler syndrome.

An exploratory, open-label, single centre, phase II, proof of concept study of gevokizumab treatment in patients with Schnitzler syndrome.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-002562-39-NL
Enrollment
Unknown
Registered
2013-07-15
Start date
2013-10-10
Completion date
Unknown
Last updated
2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schnitzler syndrome MedDRA version: 17.1 Level: PT Classification code 10062908 Term: Schnitzler's syndrome System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: Gevokizumab Product Code: S78989 Pharmaceutical Form: Solution for injection INN or Proposed INN: gevokizumab CAS Number: 1129435-60-4 Current Sponsor code: S78989 Other descriptive name

Sponsors

Institut de Recherches Internationales Servier (IRIS)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion 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 outcomes

Primary

MeasureTime frame
Main Objective: The objective of this study is to explore the efficacy and safety of gevokizumab in patients with Schnitzler syndrome.;Secondary Objective: Not applicable;Primary end point(s): Exploratory descriptive endpoints on efficacy and safety;Timepoint(s) of evaluation of this end point: All visits from inclusion to last study visit (End) or withdrawal—

Secondary

MeasureTime frame
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable—

Countries

Netherlands

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+3315572 4366

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026