Batoclimab 680 mg SC weekly for Myasthenia Gravis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Myasthenia GravisBatoclimab 680 mg SC weekly - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to treat myasthenia gravis, a rare autoimmune disease that causes muscle weakness. The drug is given either once a week or every two weeks, and the trial will measure how effective it is in treating the disease.

Eligible Conditions
  • Myasthenia Gravis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline (Week 12) to Week 24

Week 12
Change from Baseline in MG-ADL score in AChRAB- (AChRAB negative) participants
Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants
Change from Baseline in Quantitative Myasthenia Gravis (QMG) score in AChRAb+ participants
Week 24
Change from Baseline in MG-ADL score for AChRAb+ randomized withdrawal participants
Up to 76 Weeks
Number of Participants with Clinically Significant Changes in Laboratory Results
Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Percentage of participants with clinical laboratory-related TEAEs or treatment emergent laboratory abnormalities.
Up to Week 12
Percentage of AChRAb+ participants achieving MG-ADL score of 0 or 1 by Week 12
Percentage of AChRAb+ participants with greater than equal to (>=) 3-point improvement in QMG score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

6 Treatment Groups

Batoclimab Induction Dose 1 (Period 1)
1 of 6
Batoclimab Induction Dose 2 (Period 1)
1 of 6
Batoclimab Maintenance Dose 1 (Period 2)
1 of 6
Batoclimab Maintenance Dose 2 (Period 2)
1 of 6
Placebo Maintenance Dose (Period 2)
1 of 6
Placebo Induction Dose (Period 1)
1 of 6

Experimental Treatment

Non-Treatment Group

210 Total Participants · 6 Treatment Groups

Primary Treatment: Batoclimab 680 mg SC weekly · Has Placebo Group · Phase 3

Batoclimab Induction Dose 1 (Period 1)
Drug
Experimental Group · 1 Intervention: Batoclimab 680 mg SC weekly · Intervention Types: Drug
Batoclimab Induction Dose 2 (Period 1)
Drug
Experimental Group · 1 Intervention: Batoclimab 340 mg SC weekly · Intervention Types: Drug
Batoclimab Maintenance Dose 1 (Period 2)
Drug
Experimental Group · 1 Intervention: Batoclimab 340 mg SC weekly · Intervention Types: Drug
Batoclimab Maintenance Dose 2 (Period 2)
Drug
Experimental Group · 1 Intervention: Batoclimab 340 mg SC bi-weekly · Intervention Types: Drug
Placebo Maintenance Dose (Period 2)
Drug
PlaceboComparator Group · 1 Intervention: Matching Placebo SC · Intervention Types: Drug
Placebo Induction Dose (Period 1)
Drug
PlaceboComparator Group · 1 Intervention: Matching Placebo SC · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (week 12) to week 24

Who is running the clinical trial?

Immunovant Sciences GmbHLead Sponsor
8 Previous Clinical Trials
714 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
17 Patients Enrolled for Myasthenia Gravis

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a score of ≥ 5 on the MG-ADL at the Screening and Baseline Visits.
You have mild to severe MGFA class II, III, or IVa at the Screening Visit.
You are at least 18 years of age at the Screening Visit.
You have a QMG score ≥ 11 at the Screening and Baseline Visits.