Rozanolixizumab for Healthy Subjects

Recruiting at 1 trial location

Overseen By UCB Cares

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: UCB Biopharma SRL

Must not be taking: Biologics, Live vaccines

Disqualifiers: Breast surgery, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

15 Participants Needed

Trial Summary

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.

What makes the drug Rozanolixizumab unique compared to other treatments?

Rozanolixizumab is unique because it is a monoclonal antibody designed to target and reduce the activity of specific immune system components, potentially offering a novel approach for conditions where traditional treatments may not be effective. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of the study is to assess the concentration of rozanolixizumab in mature breast milk of healthy study participants following administration of a single dose of rozanolixizumab

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

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

I am breastfeeding and will be 6 weeks postpartum when the study starts.

I have chosen to stop breastfeeding before joining the study and agree not to breastfeed or donate milk for 8 weeks after getting rozanolixizumab.

* A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the Sampling Period and for at least 1 week after the last dose of study treatment OR * Not a WOCBP (ie, premenopausal female with documented hysterectomy, documented bilateral salpingectomy, or documented bilateral oophorectomy)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of subcutaneous rozanolixizumab

1 day

1 visit (in-person)

Sampling Period

Breast milk samples are collected to assess the concentration of rozanolixizumab

7 days

Daily visits for sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

1 visit (in-person)

Treatment Details

Interventions

• Rozanolixizumab

Trial Overview The study is testing the presence of rozanolixizumab in mature breast milk after administering a single dose to healthy lactating women. The goal is to understand how much, if any, of the drug passes into breast milk.

Participant Groups

Group I: Rozanolixizumab arm Experimental Treatment 1 Intervention

Study participants enrolled in this arm will receive a single dose of subcutaneous rozanolixizumab

Rozanolixizumab is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Rystiggo for:

• Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

Approved in European Union as Rystiggo for:

• Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

Approved in Japan as Rystiggo for:

• Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

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

Findings from Research

Tocilizumab, a humanized monoclonal antibody targeting sIL-6R, shows promise as a treatment for rheumatoid arthritis, with safety data from randomized controlled trials indicating no increased risk of opportunistic infections or cancers.

However, there are concerns about elevated liver function tests and altered lipid profiles, which need to be further investigated in larger studies with longer follow-up to understand their significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interleukin-6 inhibition--tolerability profile and clinical implications. Strand, V., Yazici, Y.[2016]

A 72-year-old woman developed severe anterior uveitis after receiving tocilizumab infusions for rheumatoid arthritis, suggesting a potential adverse effect of this anti-IL-6 receptor therapy.

The patient's ocular inflammation was successfully managed with corticosteroids, indicating that while tocilizumab can effectively treat rheumatoid arthritis, it may also lead to serious eye complications like uveitis after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute anterior uveitis after discontinuation of tocilizumab in a patient with rheumatoid arthritis. Sato, T., Minakuchi, S., Mochizuki, M., et al.[2021]

Tocilizumab, an anti-IL-6 receptor monoclonal antibody, effectively blocks IL-6 receptors and normalizes C-reactive protein levels in patients with rheumatoid arthritis and systemic juvenile idiopathic arthritis, with biweekly doses of 8 mg/kg for patients ≥ 30 kg and 12 mg/kg for those < 30 kg.

The pharmacokinetic parameters, including serum concentrations and area under the curve, were similar across both dosing groups, indicating consistent efficacy and safety in achieving clinical endpoints regardless of the dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pharmacology of tocilizumab for the treatment of systemic juvenile idiopathic arthritis. Zhang, X., Morcos, PN., Saito, T., et al.[2016]

In a 12-week Phase IIb study involving 221 patients with moderate-to-severe rheumatoid arthritis who had previously failed TNF inhibitor therapy, olokizumab (OKZ) significantly reduced disease activity (measured by DAS28(CRP)) compared to placebo, indicating its efficacy as a treatment option.

OKZ demonstrated similar efficacy to tocilizumab (TCZ) across multiple endpoints, with most adverse events being mild or moderate, suggesting a favorable safety profile consistent with other drugs in its class.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study. Genovese, MC., Fleischmann, R., Furst, D., et al.[2023]

In a phase IIIb trial involving 288 patients with moderate-to-severe rheumatoid arthritis (RA), weekly subcutaneous tocilizumab (TCZ-SC) significantly reduced disease activity as measured by the Clinical Disease Activity Index (CDAI) within just 2 weeks, with sustained improvements observed up to 52 weeks.

TCZ-SC demonstrated low immunogenicity and no unexpected toxicities, making it a safe option for patients, and the study suggests that home administration of the treatment is feasible after a median of just 2 doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous tocilizumab alone or with a csDMARD in rheumatoid arthritis patients: subanalysis of Italian data from a multicenter phase IIIb/IV trial. Bazzichi, L., Nacci, F., Sinigaglia, L., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Interleukin-6 inhibition--tolerability profile and clinical implications. [2016]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Acute anterior uveitis after discontinuation of tocilizumab in a patient with rheumatoid arthritis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Clinical pharmacology of tocilizumab for the treatment of systemic juvenile idiopathic arthritis. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Subcutaneous tocilizumab alone or with a csDMARD in rheumatoid arthritis patients: subanalysis of Italian data from a multicenter phase IIIb/IV trial. [2020]