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
- Conditions
- Polymyositis / Dermatomyositis/ necrotizing autoimmune myopathyMedDRA version: 17.1Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 17.1Level: PTClassification code 10036102Term: PolymyositisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2012-005772-34-DE
- Lead Sponsor
- Institut de Recherches Internationales Servier (IRIS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
- Active polymyositis, dermatomyositis or necrotizing autoimmune myopathy intolerant or resistant or dependent to systemic oral corticosteroids,
- Disease diagnosis duration =10 years,
- 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
- Juvenile dermatomyositis, drug induced myositis, severity criteria such as severe cardiovascular or pulmonary involvement or myositis damage, necrotizing myopathy, inclusion body myositis, cancer- associated myositis or DM diagnosed for less than 1 year,
- Impossibility to perform muscle biopsy for PM 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
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 evaluate the efficacy and safety of gevokizumab in adult patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy intolerant or resistant or dependent to systemic oral corticosteroids.;Secondary Objective: Not applicable;Primary end point(s): -Clinical improvement according to Manual Muscle Testing (MMT-8) score<br>-Clinical improvement according to IMACS group's myositis disease activity core set<br>-Specific dermatologic testing: modified CDASI for DM patients<br>-SF36<br>-Biomarkers;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)<br>Others : every 4 weeks from week 0 to week 24 and until week 48 visit (including withdrawal visit)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable