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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 below

Select...

I have been diagnosed with generalized Myasthenia Gravis.

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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])

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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]) for reporting.

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 • NCT04124965

29%

Headache

17%

Diarrhoea

12%

Blood immunoglobulin G decreased

12%

Nausea

10%

Vomiting

10%

Nasopharyngitis

10%

Rash

Back pain

Pyrexia

Abdominal pain

Urinary tract infection

Hypogammaglobulinaemia

Pericarditis

Myasthenia gravis

Hypertension

100%

80%

60%

40%

20%

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

2019

Completed Phase 3

~560

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor

101 Previous Clinical Trials

21,374 Total Patients Enrolled

7 Trials studying Myasthenia Gravis

595 Patients Enrolled for Myasthenia Gravis

UCB CaresStudy Director001 844 599 2273

205 Previous Clinical Trials

44,901 Total Patients Enrolled

10 Trials studying Myasthenia Gravis

944 Patients Enrolled for Myasthenia Gravis

Media Library

Rozanolixizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05681715 — Phase 3

Myasthenia Gravis Research Study Groups: Rozanolixizumab Sequence 1: Syringe Driver - Manual Push, Rozanolixizumab Sequence 2: Manual Push - Syringe Driver

Myasthenia Gravis Clinical Trial 2023: Rozanolixizumab Highlights & Side Effects. Trial Name: NCT05681715 — Phase 3

Rozanolixizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05681715 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being welcomed to join this clinical experiment?

"Records on clinicaltrials.gov demonstrate that this research initiative is actively seeking patients, having first been posted in April 17th 2023 and edited most recently on May 4th of the same year."

Answered by AI

How many volunteers are enrolled in this research endeavor?

"Affirmative. Clinicaltrials.gov attests that this examination, which was originally posted on April 17th 2023, is actively seeking participants. A total of 30 people must be recruited between two medical facilities."

Answered by AI

Has the FDA sanctioned use of Rozanolixizumab Sequence 1: Syringe Driver - Manual Push?

"The pre-existing evidence suggests Rozanolixizumab Sequence 1: Syringe Driver - Manual Push is safe, so it was assigned a rating of 3. This score takes into account its progression through Phase III trials and the efficacy data that supports it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)

2023. "A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05681715.

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