Rozanolixizumab for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand the effects of rozanolixizumab, a medication, on breast milk when administered as a single dose to lactating women. Researchers seek to determine the amount of the medicine that enters breast milk, which could inform future treatments. The trial is specifically for women who are at least six weeks postpartum, have chosen to stop breast milk feeding, and are willing to temporarily cease breastfeeding for eight weeks after taking the medication. Participants should not have had breast surgeries or recent infections. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking biologic agents (like monoclonal antibodies), you must not have used them within 3 months or 5 half-lives before the study.
Is there any evidence suggesting that rozanolixizumab is likely to be safe for humans?
Research has shown that rozanolixizumab was generally well-tolerated in past studies, which included participants with conditions like myasthenia gravis, an autoimmune disease. Some participants experienced side effects, such as headaches and injection site reactions, but these were usually mild to moderate. Importantly, the FDA has already approved rozanolixizumab for treating certain conditions, which supports its safety profile. While this trial involves healthy volunteers and only one dose, existing safety data suggest it is unlikely to cause serious harm.12345
Why do researchers think this study treatment might be promising?
Rozanolixizumab is unique because it targets the neonatal Fc receptor (FcRn), which plays a key role in the regulation of antibodies in the body. This mechanism is different from traditional treatments that often focus on suppressing the immune system more broadly. By specifically targeting FcRn, rozanolixizumab has the potential to reduce harmful antibodies without broadly dampening immune function, potentially leading to fewer side effects. Researchers are excited about its subcutaneous administration, which could offer a more convenient and less invasive option compared to intravenous treatments.
What evidence suggests that rozanolixizumab might be an effective treatment?
Research has shown that rozanolixizumab effectively treats generalized myasthenia gravis (gMG), a condition that causes muscle weakness. One study found that patients taking rozanolixizumab experienced significant improvements, with 60.9% in the lower dose group and 74.2% in the higher dose group responding well to the treatment. Another study confirmed its safety and effectiveness over a 6-week period, helping patients manage their symptoms. These findings suggest that rozanolixizumab can be a good treatment option for certain autoimmune conditions like gMG, by reducing symptoms and improving patient health. Participants in this trial will receive a single dose of subcutaneous rozanolixizumab to further evaluate its effects in healthy subjects.23678
Who Is on the Research Team?
UCB Cares
Principal Investigator
001 844 599 2273
Are You a Good Fit for This Trial?
This trial is for healthy lactating women who are at least 18 years old and a minimum of 6 weeks postpartum. Participants must agree to stop breastfeeding from Day 1 and not resume or donate breast milk for 8 weeks after receiving rozanolixizumab. Women must follow contraceptive guidance or be incapable of becoming pregnant due to medical reasons.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of subcutaneous rozanolixizumab
Sampling Period
Breast milk samples are collected to assess the concentration of rozanolixizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rozanolixizumab
Rozanolixizumab is already approved in United States, European Union, Japan for the following indications:
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
Find a Clinic Near You
Who Is Running the Clinical Trial?
UCB Biopharma SRL
Lead Sponsor
Jean-Christophe Tellier
UCB Biopharma SRL
Chief Executive Officer since 2015
MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD
Dr. Iris Loew-Friedrich
UCB Biopharma SRL
Chief Medical Officer since 2014
MD from University of Leuven, PhD in Medical Sciences from University of Leuven