IgPro20_3007_Ph3 study of IgPro20 in Adults with Dermatomyositis
Research type
Research Study
Full title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)
IRAS ID
270276
Contact name
Chee-Seng Yee
Contact email
Sponsor organisation
CSL Behring LLC
Eudract number
2018-003171-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 3 days
Research summary
The Sponsor CSL Behring are looking at a muscle disease called dermatomyositis (DM). Patients suffer with chronic muscle inflammation accompanied by muscle weakness and the main symptom is a skin rash that comes before or accompanies progressive muscle weakness. The trigger that initiates DM is not clearly understood. If left untreated, muscle weakness leads to movement difficulties (restriction to wheel chair or confinement to bed).
Standard treatments are classes of drugs that change/modulate the patients’ immune response such as corticosteroids, intravenous immunoglobulin G (IVIG), plasmapheresis, methotrexate, azathioprine, and cyclosporin A. However, the 10yr survival rate while taking these drugs is not very high and many of the drugs especially corticocosteroids are not very well tolerated long term. Therefore this disease treatment is considered an unmet need.IgPro20 is a ready-to-use liquid formulation of human immunoglobulin G (IgG).
IgPro20 is available in the United States, Europe, Switzerland, Canada, Japan, and other countries under the brand name Hizentra® for other diseases but not yet for DM. IgPro20 has been administered in studies in both immunodeficiency and immunomodulatory indications. This will be the first study in DM patients.This study will be conducted at approximately 80-100 sites globally with the aim to recruit 126 patients. It will involve a screening period (for up to 2 months). Eligible patients will be assigned randomly to IgPro20 or placebo. The Study Doctor, their research team and the patient will not know which treatment they have been assigned. The patients will have 15 site visits during a 52-week treatment period and an end of study safety follow up call. Patients will have assessments, questionnaires, electrocardiogram's (ECG's), blood and urine samples taken and they will be taught how to administer the study drug using an infusion pump.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0328
Date of REC Opinion
2 Jan 2020
REC opinion
Further Information Favourable Opinion