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

Phase 1

• Conditions: Polymyositis / Dermatomyositis / necrotizing autoimmune myopathy; MedDRA version: 18.0Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 18.0Level: PTClassification code 10036102Term: PolymyositisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-005772-34-CZ
• Lead Sponsor: Institut de Recherches Internationales Servier (IRIS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-06
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- Active polymyositis or 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

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 and 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

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 or 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 (except patients with DM sine dermatitis)<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<br>Others : every 4 weeks form week 0 to week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable