A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease.

• Register: EUCTR
• Last refreshed on: 11 April 2016
• Main ID: EUCTR2012-005772-34-SE
• Date of registration: 03/06/2013
• Prospective Registration: Yes
• Primary sponsor: Institut de Recherches Internationales Servier (IRIS)
• Public title: A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease.
• Scientific title: A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease
• Date of first enrolment: 04/09/2013
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005772-34
• 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: yes Other trial design description: followed by an open label gevokizumab administration period (except for France) If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Poland, South Africa, Spain, Sweden, 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:
- Active polymyositis or dermatomyositis or necrotizing autoimmune myopathy intolerant or resistant or dependent to systemic oral corticosteroids,
- With a stable background treatment of oral corticosteroid if any and / or a stable dose of immunosuppressive agent if any.
- Male or female, age = 18 (or legal age of majority in the country),
- Weight = 40 kg and = 125 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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
- Juvenile dermatomyositis, drug induced myositis, severity criteria such as severe cardiovascular or pulmonary involvement or myositis damage, congenital myopathy, inclusion body myositis, cancer- associated myositis or DM diagnosed for less than 1 year,
- Impossibility to perform muscle biopsy for PM, DM sine dermatitis and NAM patients (if required),
- Non-ambulatory patients,
- Fibromyalgia of type I,
- Joint disease or other musculoskeletal condition,
- 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,
- 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

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Polymyositis / Dermatomyositis / necrotizing autoimmune myopathy
MedDRA version: 17.1 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1 Level: PT Classification code 10036102 Term: Polymyositis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

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)

Main Objective: The objective of this study is to evaluate the efficacy and safety of gevokizumab in adult patients with polymyositis or dermatomyositis or necrotizing autoimmune myopathy intolerant or resistant or dependent to systemic oral corticosteroids.

Timepoint(s) of evaluation of this end point: MMT-8 and biomarkers : at selection and every 4 weeks until week 24 visit and until week 48 visit (including withdrawal visit) (only for France: at selection and every 4 weeks until week 24 visit)
Others : every 4 weeks from week 0 to week 24 and until week 48 visit (including withdrawal visit) (only for France: every 4 weeks from week 0 to week 24)

Primary end point(s): -Clinical improvement according to Manual Muscle Testing (MMT-8) score
-Clinical improvement according to IMACS group's myositis disease activity core set
-Specific dermatologic testing: modified CDASI (Cutaneous Dermatomyositis Disease Area and Severity Index) for DM patients (except patients with DM sine dermatitis)
-SF36
-Biomarkers

Secondary Objective: Not applicable

Secondary Outcome(s)

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

Secondary end point(s): Not Applicable

Secondary ID(s)

CL2-78989-010

Source(s) of Monetary Support

ADIR