ACTIVE_NOT_RECRUITING

A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.

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Conditions

Active Idiopathic Inflammatory MyopathyMyositisDermatomyositisPolymyositisImmune-Mediated Necrotizing MyopathyAntisynthetase Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome \[ASyS\]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

Official Title

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

Quick Facts

Study Start:2022-10-12
Study Completion:2027-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05523167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to consent in the jurisdiction in which the study is taking place and capable of giving signed informed consent.
  2. * A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM)
  3. * One of the following medical histories: Diagnosis of dermatomyositis (DM) or juvenile dermatomyositis (JDM), Diagnosis of polymyositis (PM) (including antisynthetase syndrome (ASyS)), Diagnosis of immune-mediated necrotizing myopathy (IMNM)
  4. * Diagnosed with active disease as defined by the presence of at least 1 of the following criteria: Abnormal levels of at least 1 of the following enzymes: creatine kinase (CK), aldolase, lactate dehydrogenase, aspartate aminotransaminase (AST), alanine aminotransferase (ALT), based on central laboratory results; Electromyography demonstrating active disease within the past 3 months; Active dermatomyositis (DM) skin rash; Muscle biopsy indicative of active idiopathic inflammatory myopathy (IIM) in the past 3 months; Magnetic resonance imaging within the past 3 months indicative of active inflammation
  5. * Muscle weakness
  6. * Receiving a permitted background treatment for idiopathic inflammatory myopathy.
  7. * Contraceptive use consistent with local regulations, where available, for individuals participating in clinical studies. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline before receiving investigational medicinal product (IMP).
  1. * A clinically significant active infection at screening
  2. * A COVID-19 polymerase chain reaction (PCR)-positive test before enrollment
  3. * Any other known autoimmune disease that, in the investigator's opinion, would interfere with an accurate assessment of clinical symptoms of idiopathic inflammatory myopathy (IIM) or put the patient at undue risk
  4. * A history of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for ≥ 3 years before the first administration of the investigational medicinal product (IMP). Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer ; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer
  5. * Severe muscle damage
  6. * Glucocorticoid-induced myopathy that the investigator considers the primary cause of muscle weakness or permanent weakness linked to a non-idiopathic inflammatory myopathy (IIM) cause
  7. * Juvenile myositis (JDM) diagnosed \> 5 years from screening or juvenile myositis with extensive calcinosis or severe calcinosis.
  8. * Uncontrolled interstitial lung disease or any other uncontrolled idiopathic inflammatory myopathy (IIM) manifestation that, in the opinion of the investigator, would be likely to require treatment with prohibited medication during the study
  9. * Other inflammatory and noninflammatory myopathies: inclusion body myositis, overlap myositis), metabolic myopathies, muscle dystrophies or a family history of muscle dystrophy, drug-induced or endocrine induced myositis, and juvenile myositis (other than juvenile dermatomyositis (JDM))
  10. * Clinically significant disease, recent major surgery or intends to have surgery during the study, or has any other condition in the opinion of the investigator that could confound the results of the trial or put the patient at undue risk
  11. * Known hypersensitivity reaction to investigational medicinal product (IMP) or 1 of its excipients
  12. * Received a live or live-attenuated vaccine less than 4 weeks before screening.
  13. * Positive serum test at screening for active viral infection with any of the following conditions: Hepatitis B virus (HBV); Hepatitis C virus (HCV); HIV
  14. * Participant has previously participated in an efgartigimod clinical trial and received at least 1 dose of investigational medicinal product (IMP).
  15. * Participant is concurrently participating in any other clinical study, including a noninterventional study.
  16. * Participant has a current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse.
  17. * Participant is pregnant or lactating or intends to become pregnant during the study.
  18. * Participant has severe renal impairment .
  19. * Participant is institutionalized by a court or other governmental order or is in a dependent relationship with the sponsor or investigator.

Contacts and Locations

Study Locations (Sites)

Neuromuscular Research Center
Phoenix, Arizona, 85028
United States
HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
Scottsdale, Arizona, 85251
United States
Attune Health Research, Inc
Beverly Hills, California, 90039
United States
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Profound Research LLC - Oceanside
Oceanside, California, 92056
United States
University of California, Irvine
Orange, California, 92868
United States
Eisenhower Medical Center
Rancho Mirage, California, 92270
United States
Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
Redwood City, California, 94063-3132
United States
California Pacific Medical Center - Sutter Health
San Francisco, California, 94109
United States
Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF)
San Francisco, California, 94143-2202
United States
Denver Arthritis Clinic
Denver, Colorado, 80230
United States
Yale Cancer Center-Yale University School Of Medicine
New Haven, Connecticut, 06520
United States
Georgetown University Hospital
Washington, District of Columbia, 20007
United States
UF Health Rheumatology
Gainesville, Florida, 32610-3008
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
Tampa, Florida, 33616
United States
Emory University Hospital, The Emory Clinic
Atlanta, Georgia, 30322
United States
Augusta University
Augusta, Georgia, 30312
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
University Of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Johns Hopkins Medicine - Johns Hopkins Myositis Center
Baltimore, Maryland, 21224
United States
Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Research Center (TRC)
Boston, Massachusetts, 02115-6110
United States
Michigan State University - Neurology
East Lansing, Michigan, 48824
United States
St. Paul Rheumatology, PA
Saint Paul, Minnesota, 55121
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Northwell Health
Great Neck, New York, 11021
United States
Hospital for Special Surgery
New York, New York, 10021
United States
University of North Carolina (UNC) School of Medicine
Chapel Hill, North Carolina, 27514-4220
United States
Carolina Arthritis Associates
Wilmington, North Carolina, 28401
United States
Cleveland Clinic - Main Campus
Cleveland, Ohio, 44195
United States
The Ohio State University
Columbus, Ohio, 43201
United States
Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology
Oklahoma City, Oklahoma, 73120
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15261
United States
Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic
Nashville, Tennessee, 37232-0028
United States
Austin Neuromuscular Center
Austin, Texas, 78759
United States
McGovern Medical School -The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
Nerve And Muscle Center Of Texas
Houston, Texas, 77030
United States
University of Vermont Medical Center - Main Campus
Burlington, Vermont, 05401
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: argenx

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-12
Study Completion Date2027-02-01

Study Record Updates

Study Start Date2022-10-12
Study Completion Date2027-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Active Idiopathic Inflammatory Myopathy
  • Myositis
  • Dermatomyositis
  • Polymyositis
  • Immune-Mediated Necrotizing Myopathy
  • Antisynthetase Syndrome