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Immunoglobulin
Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial)
Phase 2
Waitlist Available
Led By James S Andrews, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Summary
This trial will test if Gamunex-C IVIG can help people with HMGCR necrotizing myopathy by itself.
Eligible Conditions
- Necrotizing Myopathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Myositis
Secondary study objectives
ACR/EULAR Clinical Response Criteria for Myositis Total Improvement Score
Creatine kinase
HMG-CoA Reductase Auto-antibody titer level
+1 moreSide effects data
From 2022 Phase 3 trial • 33 Patients • NCT0456111516%
Headache
13%
COVID-19
13%
Sinusitis
9%
Diarrhoea
6%
Musculoskeletal Pain
6%
Dermatitis Contact
6%
Upper Respiratory Tract Infection
3%
Rhinorrhoea
3%
Low Density Lipoprotein Increased
3%
Dyspnoea
3%
Fall
3%
Skin Laceration
3%
Rales
3%
Sinus Congestion
3%
Muscle Spasms
3%
Eye Inflammation
3%
Pharyngitis
3%
Nasal Mucosal Disorder
3%
Eye Pruritus
3%
Haematochezia
3%
Traumatic iritis
3%
Epicondylitis
3%
Basal Cell Carcinoma
3%
Fungal Infection
3%
Toothache
3%
Nonalcoholic fatty liver disease
3%
Acute sinusitis
3%
Bacterial vaginosis
3%
Diverticulitis
3%
Nasopharyngitis
3%
Paronychia
3%
Periodontitis
3%
Dermatitis Atopic
3%
Rash
3%
Anemia
3%
Methylenetetrahydrofolate Reductase Gene Mutation
3%
Ear Pain
3%
Abdominal Hernia
3%
Aphthous ulcer
3%
Colitis
3%
Application site rash
3%
Urinary Tract Infection
3%
Hyphaema
3%
Ligament sprain
3%
Failure to Thrive
3%
Hypoferritinaemia
3%
Iron Deficiency
3%
Vitamin D Deficiency
100%
80%
60%
40%
20%
0%
Study treatment Arm
IVIG-PEG
Gamunex-C
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Gamunex-C IVIGExperimental Treatment1 Intervention
Gamunex-C IVIG dosed at 2g/kg will be given on week 0 and week 4.
Group II: PlaceboPlacebo Group1 Intervention
Albumin in a 1% solution at an equivalent volume to the corresponding Gamunex-C IVIG dose will be given at week 0 and week 4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gamunex-C
2020
Completed Phase 3
~40
Find a Location
Who is running the clinical trial?
Grifols Biologicals, LLCIndustry Sponsor
32 Previous Clinical Trials
9,456 Total Patients Enrolled
University of WashingtonLead Sponsor
1,831 Previous Clinical Trials
1,907,569 Total Patients Enrolled
James S Andrews, MDPrincipal InvestigatorUniversity of Washington