A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis

A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002778-38-ES

Enrollment

Registered

2013-10-18

Start date

2014-01-14

Completion date

Unknown

Last updated

2015-11-16

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

Conditions

Giant cell arteritis MedDRA version: 16.1 Level: LLT Classification code 10018250 Term: Giant cell arteritis System Organ Class: 100000004866

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Relapsing GCA with systemic symptoms, - Diagnosis of GCA according to ACR criteria and at least one previous GCA relapse, - Oral CS therapy, - Male or female, age ? 50 years, - Weight > 40 kg at selection, - For subjects with reproductive potential, a willingness to use highly effective contraceptive measures. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - relapse of GCA with symptoms indicative of a risk of ischemic event, - History of recent, permanent or transient visual loss due to GCA and the presence of any specific visual abnormality, - History of major ischemic event, unrelated to GCA, - History of fibromyalgia, - Evidence of active pulmonary infection, active TB disease, or malignancy, or suspicion of active or latent TB, or exposition to TB, - History of severe allergic or anaphylactic reactions to monoclonal antibodies, - History of malignancy within 5 years prior to selection, - Known immunodeficiency, - Infectious disease, - Pregnancy, breastfeeding or possibility to become pregnant during the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to evaluate the efficacy and safety of gevokizumab on symptoms of giant cell arteritis (GCA) in relapsing patients receiving systemic oral corticosteroids (CS);Secondary Objective: Not applicable;Primary end point(s): - Proportion of responders to treatment, - Physician Global Assessment, - Patient Global Assessment, - PMR activity score (PMR-AS), - Quality of life (SF-36), - Inflammation markers, - Corticosteroids use.;Timepoint(s) of evaluation of this end point: Response to treatment: at week 4, Physician/Patient Global Assessment, PMR-AS, inflammation markers, remission, CS use: at each visit from selection to end of study visit, SF-36 : at week 0, week 4, week 12, week 24, week 36 and end of study visit	—

Measure

Time frame

Main Objective: The objective of this study is to evaluate the efficacy and safety of gevokizumab on symptoms of giant cell arteritis (GCA) in relapsing patients receiving systemic oral corticosteroids (CS);Secondary Objective: Not applicable;Primary end point(s): - Proportion of responders to treatment, - Physician Global Assessment, - Patient Global Assessment, - PMR activity score (PMR-AS), - Quality of life (SF-36), - Inflammation markers, - Corticosteroids use.;Timepoint(s) of evaluation of this end point: Response to treatment: at week 4, Physician/Patient Global Assessment, PMR-AS, inflammation markers, remission, CS use: at each visit from selection to end of study visit, SF-36 : at week 0, week 4, week 12, week 24, week 36 and end of study visit

—

Secondary

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

Countries

Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, Ireland, Russian Federation, Spain, United Kingdom

Contacts

Public ContactLoreto TABOADA

Laboratorios Servier SL

loreto.taboada@es.netgrs.com0034917489630178

Outcome results

None listed

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