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

• Register: EUCTR
• Last refreshed on: 16 November 2015
• Main ID: EUCTR2013-002778-38-BE
• Date of registration: 09/12/2014
• Prospective Registration: Yes
• Primary sponsor: Institut de Recherches Internationales Servier (IRIS)
• Public title: A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis
• Scientific title: 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
• Date of first enrolment: 21/01/2015
• Target sample size: 50
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002778-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Ireland, Italy, Norway, Poland, Russian Federation, Spain, Switzerland, United Kingdom

Contacts

• Name: Clinical Studies Department
• Affiliation: Institut de Recherches Internationales Servier

• Name: Clinical Studies Department
• Affiliation: Institut de Recherches Internationales Servier

Key inclusion & exclusion criteria

Inclusion criteria:
- Relapsing GCA with systemic symptoms,
- Diagnosis of GCA according to modified ACR criteria,
- 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Giant cell arteritis
MedDRA version: 18.0 Level: LLT Classification code 10018250 Term: Giant cell arteritis System Organ Class: 100000004866

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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: XOMA 052
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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.

Secondary Objective: Not applicable

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

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 Outcome(s)

Timepoint(s) of evaluation of this end point: Not Applicable

Secondary end point(s): Not Applicable

Secondary ID(s)

CL2-78989-012

2013-002778-38-ES

Source(s) of Monetary Support

Servier Research and Development Ltd

ADIR

Laboratorios Servier, S.L.