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Monoclonal Antibodies

TAK-079 for Myasthenia Gravis

Phase 2
Waitlist Available
Research Sponsored by Takeda
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 at weeks 4, 6, 8, 10, 12, 14, 16, 20, 24, 28 and 32
Awards & highlights

Study Summary

This trial is testing a new medication, TAK-079, to see if it is effective and safe for people with myasthenia gravis, an autoimmune condition causing muscle weakness.

Eligible Conditions
  • Myasthenia Gravis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 4, 6, 8, 10, 12, 14, 16, 20, 24, 28 and 32
This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 4, 6, 8, 10, 12, 14, 16, 20, 24, 28 and 32 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation
Secondary outcome measures
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels
Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score
+6 more

Side effects data

From 2022 Phase 2 trial • 36 Patients • NCT04159805
17%
Pyrexia
8%
Depression
8%
Diplopia
8%
Atrioventricular block first degree
8%
Suicidal ideation
8%
Malaise
8%
Conjunctivitis allergic
8%
Dysarthria
8%
Dyspnoea exertional
8%
Fatigue
8%
Injection site pain
8%
Muscular weakness
8%
Paraesthesia
8%
Influenza like illness
8%
Lymphocyte count decreased
8%
Myasthenia gravis
8%
Parosmia
8%
Periorbital oedema
8%
Visual impairment
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAK-079 Placebo-matching
TAK-079 300 mg
TAK-079 600 mg

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: TAK-079 600 mgExperimental Treatment1 Intervention
TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
Group II: TAK-079 300 mgExperimental Treatment1 Intervention
TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
Group III: TAK-079 Placebo-matchingPlacebo Group1 Intervention
TAK-079 placebo-matching injection, subcutaneously (SC), once weekly in combination with standard background therapy for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-079
2014
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,226 Total Patients Enrolled
Medical DirectorStudy DirectorTakeda
2,777 Previous Clinical Trials
8,063,828 Total Patients Enrolled
3 Trials studying Myasthenia Gravis
274 Patients Enrolled for Myasthenia Gravis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of TAK-079 in People With Generalized Myasthenia Gravis
2020. "A Study of TAK-079 in People With Generalized Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04159805.
~7 spots leftby Apr 2025
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