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/.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
265
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer
Neuromuscular Research Center
Phoenix, Arizona, United States
HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
Scottsdale, Arizona, United States
Attune Health Research, Inc
Beverly Hills, California, United States
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, United States
Profound Research LLC - Oceanside
Oceanside, California, United States
Total improvement score (TIS); measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Time frame: phase 2: 24 weeks; phase 3: 52 weeks
Time to reach TIS ≥ 20 (first "minimal clinical improvement")
Time frame: phase 2: up to 24 weeks; phase 3: up to 52 weeks
Percentage of participants with TIS ≥ 20
Time frame: phase 2: 24 weeks; phase 3: 52 weeks
Time to reach TIS ≥ 40 (first "moderate clinical improvement")
Time frame: phase 2: up to 24 weeks; phase 3: up to 52 weeks
Percentage of participants with TIS ≥ 40
Time frame: phase 2: 24 weeks; phase 3: 52 weeks
Change in manual muscle testing-8 (MMT8) score
Time frame: phase 2: 24 weeks; phase 3: 52 weeks
Change in Patient Global Assessment of Disease Activity (PGA)
Time frame: phase 2: 24 weeks; phase 3: 52 weeks
Change in Physician Global Assessment of Disease Activity (MDGA)
Time frame: phase 2: 24 weeks; phase 3: 52 weeks
Proportion of participants achieving target dose of ≤ 5 mg (prednisone equivalent)
Time frame: Phase 3: 52 weeks
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University of California, Irvine
Orange, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
Redwood City, California, United States
California Pacific Medical Center - Sutter Health
San Francisco, California, United States
Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF)
San Francisco, California, United States
...and 192 more locations