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Monoclonal Antibodies
Self-Administered Rozanolixizumab for Myasthenia Gravis
Phase 3
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG)
Body weight ≥35 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours after each administration during the training period (baseline to visit 7 [week 6] and self-administration periods (visit 8 [week 7] to visit 19 [week 18])
Awards & highlights
Study Summary
This trial is testing if people with Myasthenia Gravis can give themselves an injection.
Who is the study for?
This trial is for individuals with generalized Myasthenia Gravis (gMG) who are capable of self-administering medication and weigh at least 35 kg. Participants must be willing to use a syringe driver or manual push method after training. Those with severe muscle weakness, hypersensitivity to similar drugs, active infections, recent live vaccinations, or certain medical histories cannot join.Check my eligibility
What is being tested?
The study tests if patients with gMG can successfully self-administer the drug Rozanolixizumab using a syringe driver or by hand. The focus is on patient independence in managing their treatment after receiving proper instruction.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions related to the immune system due to the nature of Rozanolixizumab as an immunotherapy and local issues at the injection site from self-administration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with generalized Myasthenia Gravis.
Select...
My body weight is at least 35 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 hours after each administration during the training period (baseline to visit 7 [week 6] and self-administration periods (visit 8 [week 7] to visit 19 [week 18])
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours after each administration during the training period (baseline to visit 7 [week 6] and self-administration periods (visit 8 [week 7] to visit 19 [week 18])
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respectively) during the Self-administration Period at Visit 13
Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respectively) during the Self-administration Period at Visit 19
Secondary outcome measures
Occurrence of Treatment-Emergent Adverse Events (TEAEs) after syringe driver or manual push self-administration from Visit 2 up to the End of Study Visit
Occurrence of local site reactions up to 24 hours after each administration during the Training Period and Self-administration Periods
Occurrence of medication errors associated with adverse reactions during the 2 Self-administration Periods of the study
Side effects data
From 2021 Phase 3 trial • 71 Patients • NCT0412496529%
Headache
17%
Diarrhoea
12%
Blood immunoglobulin G decreased
12%
Nausea
10%
Vomiting
10%
Nasopharyngitis
10%
Rash
7%
Back pain
7%
Pyrexia
5%
Abdominal pain
5%
Urinary tract infection
5%
Hypogammaglobulinaemia
2%
Pericarditis
2%
Myasthenia gravis
2%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rozanolixizumab ~10 mg/kg
Rozanolixizumab ~7 mg/kg
Trial Design
2Treatment groups
Experimental Treatment
Group I: Rozanolixizumab Sequence 2: Manual Push - Syringe DriverExperimental Treatment1 Intervention
Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.
Group II: Rozanolixizumab Sequence 1: Syringe Driver - Manual PushExperimental Treatment1 Intervention
Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rozanolixizumab
2023
Completed Phase 3
~620
Find a Location
Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
103 Previous Clinical Trials
21,744 Total Patients Enrolled
7 Trials studying Myasthenia Gravis
595 Patients Enrolled for Myasthenia Gravis
UCB CaresStudy Director001 844 599 2273
206 Previous Clinical Trials
45,104 Total Patients Enrolled
10 Trials studying Myasthenia Gravis
944 Patients Enrolled for Myasthenia Gravis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a live vaccine recently and do not plan to during the study.I am willing and able to administer my own treatment at home.I haven't had a serious infection or been hospitalized for one in the last 6 weeks.I am allergic to certain medication ingredients, including polysorbate 80 and L-proline.My doctor thinks I should try the rozanolixizumab treatment mentioned in this study.I have been diagnosed with generalized Myasthenia Gravis.My body weight is at least 35 kg.I am either male or female.I have or am at high risk for tuberculosis, or have had a nontuberculous mycobacterial infection.I have severe muscle weakness due to myasthenia gravis.
Research Study Groups:
This trial has the following groups:- Group 1: Rozanolixizumab Sequence 1: Syringe Driver - Manual Push
- Group 2: Rozanolixizumab Sequence 2: Manual Push - Syringe Driver
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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