Extension study to evaluate the long-term efficacy, safety and tolerabilityof BYM338 in patients with sporadic inclusion body myositis

Phase 1

• Conditions: Sporadic Inclusion Body Myositis; MedDRA version: 20.0Level: PTClassification code 10066407Term: Inclusion body myositisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-001411-12-IT
• Lead Sponsor: OVARTIS FARMA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-27
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

- Patients who completed the core study
- Written informed consent must be obtained before any extension study
assessment is performed
- Able to communicate well with the investigator
- Willing to participate for the entire duration of the extension study with
commitment to follow study requirements and procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168

Exclusion Criteria

- Women who are pregnant
- Women of child-bearing potential unless they are using highly effective
methods of contraception during dosing and for 6 months after the last
BYM338 dose
- Current use of prohibited treatments
- History of severe hypersensitivity reaction in the core study
- History of adverse event(s) (including those from the core study) prior
to the start of study drug in the extension study that, in the judgment of
the investigator, taking into account the subject's overall status, prevent
the subject from entering the extension study
- Clinically significant abnormal liver function tests
- Any medical condition or laboratory finding which, in the opinion of the
investigator may interfere with participation in the study, might
confound the results of the study, or pose an additional safety risk in
administering BYM338
Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified