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.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005772-34-SE

Enrollment

Registered

2013-06-03

Start date

2013-09-04

Completion date

Unknown

Last updated

2016-04-11

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

Conditions

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

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: - 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

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

Design outcomes

Primary

Measure	Time frame
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 -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;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)	—

Measure

Time frame

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 -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;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)

—

Secondary

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

Countries

Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Poland, South Africa, Spain, Sweden, United Kingdom

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33155 72 43 6

Outcome results

None listed

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