Zilucoplan for Breastfeeding Assessment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how zilucoplan, a medication, and its byproducts appear in breast milk after repeated daily injections. The focus is on understanding the drug levels in the milk of healthy breastfeeding women who plan to stop breastfeeding. Women at least six weeks postpartum, currently lactating, and who have decided to stop breastfeeding during this period may qualify for the study. Participants must be healthy and up-to-date with meningococcal vaccinations. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants a chance to contribute to early-stage medical research.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that zilucoplan is likely to be safe for humans?
Research has shown that zilucoplan is unlikely to be absorbed by a breastfed baby, suggesting it probably won't harm the baby. Studies indicate that zilucoplan may break down in both the mother's and baby's bodies, reducing the likelihood of absorption. No special precautions are necessary for breastfeeding while using this treatment. Prospective participants should discuss any concerns with their healthcare provider before joining the trial.12345
Why do researchers think this study treatment might be promising?
Zilucoplan is unique because it offers a novel approach to assessing breastfeeding by potentially targeting the immune system in a new way. Unlike traditional breastfeeding treatments that focus on nutritional support or lactation aids, Zilucoplan is a C5 complement inhibitor, which means it could help manage immune-related challenges during breastfeeding. Researchers are excited about this treatment because it may provide a faster, more direct method to address underlying issues that affect breastfeeding success.
What evidence suggests that zilucoplan might be an effective treatment for breastfeeding assessment?
Studies have shown that zilucoplan can help treat generalized myasthenia gravis (gMG), a condition that causes muscle weakness. One study found that 73% of people using zilucoplan felt better after 12 weeks. The treatment blocks certain proteins that harm the nerves, contributing to its effectiveness. Zilucoplan breaks down into smaller parts in the body, reducing the likelihood of directly affecting breastfeeding. This trial will assess how zilucoplan and its breakdown products appear in breast milk.16789
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 6 weeks postpartum and have decided to stop breastfeeding. They must be in good health, up to date with certain vaccinations, able to consent, and agree not to resume or donate breast milk after the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily injections of zilucoplan to assess its concentration in breast milk
Sampling
Breast milk samples are collected to measure zilucoplan and its metabolites
Follow-up
Participants are monitored for treatment emergent adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Zilucoplan
Trial Overview
The study tests how much of the drug Zilucoplan and its main breakdown products show up in breast milk when taken daily by healthy breastfeeding women who plan to stop nursing.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Study participants enrolled in this arm will receive daily ZLP injections.
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
Citations
216834Orig1s000 - accessdata.fda.gov
4487-1 Conduct a worldwide descriptive study that collects prospective and retrospective data in women exposed to zilucoplan during pregnancy.
Zilucoplan - Drugs and Lactation Database (LactMed®) - NCBI
Zilucoplan is expected to be degraded into small peptides and amino acids via catabolic pathways in the maternal circulation and infant gastrointestinal tract.
Subcutaneous zilucoplan: Evaluation of reproductive ...
Overall pregnancy loss (including stillbirths and death during birth) was 25.0 % (4/16) in the control group compared with 37.5 % (6/16) in the zilucoplan- ...
Zilucoplan for Breastfeeding Assessment
The purpose of this study is to assess the steady state (SS) concentrations of zilucoplan (ZLP) and its major metabolites in mature breast milk of healthy ...
See the Results From the ZILBRYSQ® Clinical Trial
73% of participants receiving ZILBRYSQ experienced improvement in gMG symptoms at Week 12. 73% (63 out of 86 participants) in the 0.3 mg/kg group compared to 46 ...
ZILBRYSQ® Safety and Side Effects
It is not known if ZILBRYSQ passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ZILBRYSQ. Tell your ...
Zilucoplan - accessdata.fda.gov
There are no data on the presence of zilucoplan in human milk, the effects on the ... Safety and effectiveness in pediatric patients have not been established.
Zilucoplan (Zilbrysq) Use During Pregnancy
-This drug is expected to be degraded in the maternal circulation and infant's gastrointestinal tract and is unlikely to be absorbed by a breastfed infant or ...
9.
mayoclinic.org
mayoclinic.org/drugs-supplements/zilucoplan-subcutaneous-route/description/drg-20559725Zilucoplan (subcutaneous route) - Side effects & dosage
Breastfeeding. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the ...
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