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A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
Jacksonville, Fla.
The purpose of this study is to measure the treatment response from Efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM).
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A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
Jacksonville, Fla.
The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in
ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.
IIM is a disease of the immune system that causes weakness of the pelvic muscles, the shoulder girdle muscles, or both. These symptoms lead to difficulties in ADL and reduce quality of life. The typical treatment for IIM is high-dose glucocorticoids combined with immunosuppressive drugs.
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A Second Intermediate-Size Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (Pridopidine EAP 2) (EAP 2)
Rochester, Minn.
The purpose of this study is to provide access to the investigational product, pridopidine, for up to 200 participants with ALS who are ineligible for clinical trials.
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HEALEY ALS Platform Trial (HEALEY)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the safety and effectiveness of investigational products for the treatment of ALS.
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PLS Natural History Study (PLS)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to develop a natural history dataset and biorepository of early Primary Lateral Sclerosis (PLS) and well-established PLS cases for future clinical trials.
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Closed for Enrollment
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
what is the efficacy of lenabasum compared to placebo in subjects with dermatomyositis (DM) as measured by TotalImprovement Score (TIS)
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A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to determine the effectiveness, safety, and tolerability of subcutaneous (SC) dosing of ABC008 in subjects with inclusion body myositis (IBM).
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FRT- 2019: Pilot Study of Electrical Impedance Myography as an Outcome Measure in Myositis
Jacksonville, Fla.
The purpose of this study is to assess Electrical Impedance Myography (EIM) as an outcome measure in patients with Idiiopathic Inflammatory Myopathies (IIM) or Myositis.
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