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Monoclonal Antibodies
Batoclimab for Myasthenia Gravis
Phase 3
Recruiting
Research Sponsored by Immunovant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits
Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 12) to week 24
Awards & highlights
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.
Who is the study for?
Adults over 18 with generalized Myasthenia Gravis (gMG) who experience muscle weakness. They should have specific scores on the QMG and MG-ADL scales, indicating mild to severe gMG. Those who've had a recent myasthenic crisis, thymectomy, untreated malignant thymoma, or certain immunosuppressive treatments are excluded.Check my eligibility
What is being tested?
The trial is testing Batoclimab's effectiveness for gMG at different doses: 680 mg weekly or 340 mg weekly/bi-weekly versus placebo. It has three periods: initial treatment randomization, dose adjustment re-randomization for responders, and long-term extension for sustained response.See study design
What are the potential side effects?
While not specified here, potential side effects of Batoclimab may include injection site reactions like pain or swelling, allergic reactions ranging from rash to anaphylaxis, infections due to immune system suppression and possibly others as it targets the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My myasthenia gravis symptoms are moderate to severe.
Select...
My myasthenia gravis is classified as mild to severe.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 12) to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 12) to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants
Secondary outcome measures
Change from Baseline in MG-ADL score for AChRAb+ randomized withdrawal participants
Change from Baseline in MG-ADL score in AChRAB- (AChRAB negative) participants
Change from Baseline in Quantitative Myasthenia Gravis (QMG) score in AChRAb+ participants
+6 moreTrial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Batoclimab Maintenance Dose 2 (Period 2)Experimental Treatment1 Intervention
Group II: Batoclimab Maintenance Dose 1 (Period 2)Experimental Treatment1 Intervention
Group III: Batoclimab Induction Dose 2 (Period 1)Experimental Treatment1 Intervention
Group IV: Batoclimab Induction Dose 1 (Period 1)Experimental Treatment1 Intervention
Group V: Placebo Induction Dose (Period 1)Placebo Group1 Intervention
Group VI: Placebo Maintenance Dose (Period 2)Placebo Group1 Intervention
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Who is running the clinical trial?
Immunovant Sciences GmbHLead Sponsor
9 Previous Clinical Trials
796 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
17 Patients Enrolled for Myasthenia Gravis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had treatments that weaken my immune system in the past year.My myasthenia gravis symptoms are moderate to severe.I had my thymus gland removed less than 6 months ago or will have it removed during the study.I have used anti-FcRn treatment in the last 3 months or it didn't work for me before.My myasthenia gravis is classified as mild to severe.I am 18 years old or older.I have an active or untreated cancer in my thymus gland.I have had a severe muscle weakness episode in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Batoclimab Induction Dose 2 (Period 1)
- Group 2: Batoclimab Maintenance Dose 2 (Period 2)
- Group 3: Batoclimab Induction Dose 1 (Period 1)
- Group 4: Placebo Induction Dose (Period 1)
- Group 5: Batoclimab Maintenance Dose 1 (Period 2)
- Group 6: Placebo Maintenance Dose (Period 2)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum dosage of Batoclimab that is considered safe for human use?
"Batoclimab 680 mg SC weekly is estimated to be a 3 on the Power team's safety scale. This is due to this being a Phase 3 trial, which means that there is some data supporting efficacy as well as multiple rounds of data supporting safety."
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