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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05155345
Recruitment Status : Recruiting
First Posted : December 13, 2021
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of mosunetuzumab in participants with systemic lupus erythematosus (SLE).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Mosunetuzumab Drug: Tocilizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 11, 2022
Estimated Primary Completion Date : July 21, 2023
Estimated Study Completion Date : July 21, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Non-fractionated/Dose-finding
Participants will receive a single dose of mosunetuzumab.
Drug: Mosunetuzumab
Participants will receive subcutaneous (SC) mosunetuzumab on either Day 1 or on Days 1 and 8.

Drug: Tocilizumab
Participants will receive intravenous (IV) tocilizumab as needed to manage adverse reactions.

Experimental: Fractionated/Dose-escalation
Participants will receive a fractionated (divided) dose of mosunetuzumab on Days 1 and 8.
Drug: Mosunetuzumab
Participants will receive subcutaneous (SC) mosunetuzumab on either Day 1 or on Days 1 and 8.

Drug: Tocilizumab
Participants will receive intravenous (IV) tocilizumab as needed to manage adverse reactions.




Primary Outcome Measures :
  1. Percentage of participants with adverse events (AEs) [ Time Frame: For a minimum of 12 months after mosunetuzumab dose ]

Secondary Outcome Measures :
  1. Serum concentration of mosunetuzumab [ Time Frame: Through Month 12 ]
  2. Peripheral B-cell count [ Time Frame: Through Month 12, then every 6 months thereafter ]
  3. Duration of B-cell depletion [ Time Frame: Through Month 12, then every 6 months thereafter ]
  4. Change from baseline in anti-drug antibodies (ADAs) [ Time Frame: Through Month 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05155345


Contacts
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Contact: Reference Study ID Number: GA43191 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com

Locations
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United States, Alabama
Pinnacle Research Group; Llc, Central Recruiting
Anniston, Alabama, United States, 36207
United States, New York
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Georgia
LLC ARENSIA Exploratory Medicine Recruiting
Tbilisi, Georgia, 0112
Moldova, Republic of
ICS ARENSIA Exploratory Medicine Recruiting
Chisinau, Moldova, Republic of, MD-2025
Ukraine
Medical Center of Limited Liability Company "Harmoniya krasy" Recruiting
Kyiv, KIEV Governorate, Ukraine, 01135
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05155345    
Other Study ID Numbers: GA43191
First Posted: December 13, 2021    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases