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

Active, not recruiting

• Conditions: Schnitzler syndrome; MedDRA version: 17.1Level: PTClassification code 10062908Term: Schnitzler's syndromeSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-002562-39-NL
• Lead Sponsor: Institut de Recherches Internationales Servier (IRIS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-15
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable