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A clinical trial to compare different doses of mosunetuzumab in people with systemic lupus erythematosus (SLE)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus
- Systemic Lupus Erythematosus
Trial Status:
Recruiting
This trial runs in
Cities
- Anniston
- Bydgoszcz
- Chișinău
- Kyiv
- Poznań
- Syracuse
- T'bilisi
Trial Identifier:
NCT05155345 GA43191
Trial Summary
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of mosunetuzumab in participants with systemic lupus erythematosus (SLE).
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT05155345 , GA43191
Trial Identifier
All
Gender
≥18 Years & ≤ 75 Years
Age
No
Healthy Volunteers
How does the GA43191 clinical trial work?
This clinical trial is recruiting people who have a disease called systemic lupus erythematosus (SLE).
The purpose of this clinical trial is to test the safety of mosunetuzumab at different doses and to understand the way your body processes mosunetuzumab.
Mosunetuzumab is an antibody that targets and eliminates B cells (a certain type of white blood cell). In people with SLE, B cells produce proteins called autoantibodies, which attack the body’s own tissues by mistake.
How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must be between 18 and 75 years old and have been diagnosed with SLE according to certain criteria (this may be confirmed with tests to look for specific proteins called autoantibodies in your blood). You must also currently be receiving certain medication(s) for treatment of SLE.
You must not be pregnant or breastfeeding, or intending to become pregnant within three months of your last dose of mosunetuzumab. If you have taken certain medications or have certain other medical conditions, you may not be able to take part in this clinical trial.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.
You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or will need to use reliable contraception for safety reasons.
What treatment will I be given if I join this clinical trial?
Everyone who joins this clinical trial will enter a screening period to make sure they are able to take part. You will then be placed into one of three treatment groups:
- Group 1: You will be given a single injection of mosunetuzumab under the skin (subcutaneous) on Day 1
- Group 2: You will be given two injections of mosunetuzumab under the skin – the first injection on Day 1 and the second on Day 8
- Group 3 may be started if there is a need for the clinical trial researchers to obtain more information. You will be given one (on Day 1) or two (on Days 1 and 8) injections of mosunetuzumab under the skin. The information obtained from Groups 1 and 2 will be used to choose the dose or doses for Group 3
Your group will be decided by how far the clinical trial has progressed at the time you join. Enrolment in Group 2 and Group 3 will not begin until the assessment period for Group 1 has been completed. You can only participate in one group.
All participants will receive mosunetuzumab. This is an open-label trial, which means that you and your clinical trial doctor will both know the dose you will receive and the group you are in.
How often will I be seen in follow-up appointments and for how long?
You will be given the clinical trial treatment mosunetuzumab for one or two doses as described above. You are free to stop this treatment at any time. After being given treatment, if you are in Group 1, you will be asked to stay in the hospital for three days after the injection so that your health can be observed closely. If you are in Group 2 or 3, you will also be asked to stay in the hospital for three days after each injection so that your health can be observed closely. The need for hospitalisation will be checked many times as the clinical trial continues and the gathered safety data are examined. If you are not hospitalised, you will have eight assessment visits in the next 14 days.
You will be followed up for safety for at least 12 months from your last injection. You will have weekly visits for the first month, followed by monthly visits up to and including Month 6, and finally visits at Month 9 and Month 12. If the number of B cells (a type of white blood cell) in your blood remains low at Month 12, you will have additional visits every six months until your number of B cells recovers or until the clinical trial ends, whichever occurs first.
These visits will include checks to see how you are feeling and to collect information about your health.
What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT05155345
Trial-identifier: NCT05155345
Trial Summary
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of mosunetuzumab in participants with systemic lupus erythematosus (SLE).
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT05155345 , GA43191
Trial Identifier
Mosunetuzumab, Tocilizumab
Treatments
Systemic Lupus Erythematosus
Condition
Official Title
A Phase Ib, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus
Eligibility Criteria
All
Gender
≥18 Years & ≤ 75 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria at least 12 weeks or more prior to screening
- Presence of one or more of the following SLE autoantibodies documented within the 12 months prior to screening or during screening: positive ANA (greater than or equal to 1:160); anti dsDNA above the upper limit of normal (ULN); anti-Sm above the ULN
- Active SLE disease, as demonstrated by a SLEDAI-2K total score of greater than or equal to 4 at screening
- Current receipt of one or more of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroids (OCSs), antimalarial agents, conventional immunosuppressants
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol
- For men on mycophenolate mofetil (MMF): With a female partner of childbearing potential, men who are not surgically sterile must remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol
Exclusion Criteria
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab and 3 months after the final dose of tocilizumab
- Active severe or unstable lupus-associated neuropsychiatric disease that is likely to require treatment with protocol-prohibited therapies
- Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening
- Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening
- Presence of significant lupus-associated renal disease and/or renal impairment that is likely to require treatment with protocol-prohibited therapies
- Peripheral CD19+ B-cell count < 25 cells/uL
- Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study
- Receipt of any of the following excluded therapies: any anti-CD19 or anti-CD20 therapy such as blinatumomab, obinutuzumab, rituxumab, ocrelizumab, or ofatumumab less than 12 months prior to screening or during screening; inhibitors of JAK, Bruton tyrosine kinase, or tyrosine kinase 2, including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib, or any investigational agent within 30 days prior to screening or during screening; tacrolimus, ciclosporin, or voclosporin within 30 day prior to screening or during screening; cyclophosphamide or a biologic therapy such as but not limited to belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during 2 months prior to screening or during screening; any live or attenuated vaccine during 28 days prior to screening or during screening
- High risk for any clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions
- Significant or uncontrolled medical disease that would preclude participation
- HIV infection, acute or chronic hepatitis B virus (HBV), acute or chronic hepatitis C (HCV) infection, tuberculosis (TB) infection, known or suspected chronic active Epstein-Barr virus (EBV) infection, or cytomegalovirus (CMV) infection
- Active infection of any kind, excluding fungal infection of the nail beds
- Any major episode of infection that fulfills any of the following criteria: requires hospitalization during 8 weeks prior to screening or during screening; requires treatment with IV antibiotics (or anti-infective medications) during 8 weeks prior to screening or during screening; requires treatment with oral antibiotics (or anti-infective medications) during 2 weeks prior to screening or during screening
- History of serious recurrent or chronic infection
- History of progressive multifocal leukoencephalopathy (PML)
- History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years
- Major surgery requiring hospitalization during 4 weeks prior to screening or during screening or any planned surgery or procedure requiring hospitalization during 12 weeks following study drug administration
- Current alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening or during screening
- Intolerance or contraindication to study therapies including history of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of mosunetuzumab injection
- Positive serum human chorionic gonadotropin measures at screening
- Any of the following laboratory parameters: aspartate transaminase (AST) or alanine transaminase (ALT) > 2.5 x upper limit of normal (ULN); total bilirubin > 1.5 x ULN; absolute neutrophil count (ANC) < 2.0 x 10^9/L (< 2000/mm^3); platelet count < 100 x 10^9/L (100,000 mm^3); hemoglobin < 100 g/L (10 g/dL); estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m^2 calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation; positive serum human chorionic gonadotropin measured at screening
For the latest version of this information please go to www.forpatients.roche.com