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

Phase 2

Completed

• Conditions: schnitzler syndrome; 10003816

• Registration Number: NL-OMON40255
• Lead Sponsor: Servier R&D Benelux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Exploratory descriptive endpoints on efficacy and safety.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>