NL-OMON55228CompletedPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) - The RECLAIIM Study - IgPro20_3007 (2102/0079); Immunoglobulin research with dermatomyositis
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- CSL Behring LLC
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Capable of providing written informed consent by signing an informed consent
- •form and willing and able to adhere to all protocol requirements
- •Age >= 18 years
- •Diagnosis of at least probable idiopathic inflammatory myopathies per
- •European League
- •Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification
- •Criteria: minimum aggregate score of 5.5 without and 6.7 with muscle biopsy
- •(historical muscle biopsy is acceptable) which includes confirmation of DM rash
- •/ skin manifestation (present or by history [historical skin biopsy is required
- •for amyopathic DM subjects])
- •Disease activity defined by:
- •Presence of DM rash / skin manifestation (eg, Gottron's papules / sign,
- •heliotrope rash, periorbital edema, V sign, Shawl sign) at Screening Visit OR
- •One objective disease activity measure within 3 months before Baseline:
- •o Magnetic resonance imaging showing active inflammation (edema) of a proximal
- •skeletal muscle - OR -
- •o Electromyogram showing acute changes such as spontaneous activity not
- •explained by other disease - OR -
- •o Muscle biopsy with perivascular or perimysial inflammation - OR -
- •o CK > 4 x upper limit of normal (ULN)
- •Disease severity defined by a minimum value of 2 cm on a 10 cm Physician
- •Global Disease Activity Visual Analog Scale and:
- •o MMT-8 <= 142 OR
- •o CDASI total activity score >= 14
- •Subject has failed other DM treatment or is on DM treatment such as
- •immunosuppressants and/or antimalarials on a stable dose >= 3 months before
- •Baseline; and/or oral corticosteroids (<= 20 mg/day prednisolone equivalent
- •and/or topical) on a stable dose >= 1 month before Baseline
Exclusion Criteria
- •Cancer-associated myositis, defined as the diagnosis of myositis within 2
- •years of the diagnosis of cancer
- •Evidence of malignancies diagnosed within the previous 5 years. Note:
- •Subjects with a history of carcinoma in situ of the cervix that has been
- •excised and cured with >= 5 years since excision or subjects with documented
- •history of treated basal or squamous cell skin cancer may be enrolled into the
- •Physician Global Damage Assessment >= 3 on a 5-point Likert scale where a
- •score of 3 represents severe damage
- •Clinically relevant improvement between Screening Visit and Baseline, defined
- •by >= 2 cm improvement on a 10 cm Physician Global Disease Activity Assessment
- •Visual Analog Scale
- •Known or suspected hypersensitivity or other severe reactions to IgPro20 or
- •to any of its excipients, or other immunoglobulins (Igs)or severe reactions to
- •blood products
- •Other significant medical conditions that could increase the risk to the
- •subject, eg:
- •o History of allogeneic bone marrow / stem cell transplant / solid organ
- •o Cardiac insufficiency (New York Heart Association Class III or IV) or
- •unstable ischemic heart disease
- •o Chronic kidney disease stage IV or V
- •o Recent surgery requiring general anesthesia within the previous 4 weeks
- •before Screening
- •o Known hyperprolinemia type I or type II
- •o Documented thrombophilic abnormalities including blood hyperviscosity,
- •protein C or protein S deficiency, anti-thrombin-III deficiency, plasminogen
- •deficiency, antiphospholipid antibodies, Factor V Leiden mutation,
- •dysfibrinogenemia, or prothrombin G20210A mutation
- •o History of documented thrombotic episode, eg, pulmonary embolism, deep vein
- •thrombosis, myocardial infarction, or thromboembolic stroke at any time
- •o More than 3 of the following specified risk factors for thromboembolic events
- •(documented and current conditions) occurring concurrently: atrial
- •fibrillation, coronary disease, diabetes mellitus, dyslipidemia, hypertension,
- •obesity (body mass index >= 30 kg/m2), recent significant trauma and immobility
- •(wheelchairbound or bedridden)
- •o Uncontrolled, severe, or rapidly progressive interstitial lung disease which
- •will prevent the subject from successful participation in the study
- •o Severe skin disease at planned infusion sites that would make subcutaneous
- •(SC) infusions infeasible
- •o Medical conditions whose symptoms and effects could alter protein catabolism
- •and or Immunoglobulin G (IgG) utilization (eg, protein-losing enteropathies,
- •nephrotic syndrome, known Immunoglobulin A [IgA] deficiency with antibodies to
- •Immunoglobulin A)
- •Other conditions which would prevent correct assessment or lead to impaired
- •muscle strength (eg, other neurological disorders including, but not limited
- •to, Parkinson*s disease or severe musculoskeletal conditions like severe
- •osteoarthritis or deformities)
- •Laboratory exclusions at Screening:
- •o positive result for any of the following human immunodeficiency virus (HIV),
- •hepatitis B virus (HBV), hepatitis C virus (HCV)
- •o Creatinine > 1.5 × ULN or Blood Urea Nitrogen (BUN) > 3 × ULN
- +4 more not shown
Investigators
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