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Monoclonal Antibodies
Mosunetuzumab for Lupus
Phase 1
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For men on mycophenolate mofetil (MMF) with a female partner of childbearing potential: agreement to remain abstinent or use contraception as defined by the protocol
Active SLE disease demonstrated by a SLEDAI-2K total score of ≥4 at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through month 12, then every 6 months thereafter
Awards & highlights
Study Summary
This trial will test mosunetuzumab, a potential new lupus treatment, for safety, how well it is tolerated, and how it works in the body.
Who is the study for?
This trial is for adults with systemic lupus erythematosus (SLE) who are currently on stable SLE medications and have certain autoantibodies. They must not have severe kidney disease, uncontrolled medical conditions, or a recent history of significant infections or surgeries. Participants should not be pregnant, breastfeeding, or planning pregnancy soon after the trial. Men on specific treatments must also follow contraception guidelines.Check my eligibility
What is being tested?
The study tests Mosunetuzumab's safety and how it affects the body in those with SLE. It will look at how well participants tolerate the drug and measure its levels in their system over time to understand its pharmacodynamics.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to monoclonal antibodies like Mosunetuzumab, infusion-related reactions such as fever or chills, fatigue, changes in blood counts leading to increased infection risk or bleeding tendencies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to follow the birth control requirements while on MMF.
Select...
My lupus is active, with a score of 4 or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through month 12, then every 6 months thereafter
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through month 12, then every 6 months thereafter
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with adverse events (AEs)
Secondary outcome measures
Change from baseline in anti-drug antibodies (ADAs)
Duration of B-cell depletion
Peripheral B-cell count
+1 moreSide effects data
From 2021 Phase 1 trial • 23 Patients • NCT0431360841%
Cytokine release syndrome
35%
Diarrhoea
35%
Hypomagnesaemia
35%
Pyrexia
35%
Neuropathy peripheral
35%
Anaemia
24%
Thrombocytopenia
24%
Hypophosphataemia
24%
Liver function test abnormal
24%
Nausea
24%
Neutropenia
24%
Fatigue
24%
Constipation
24%
Platelet count decreased
18%
Headache
18%
Sepsis
18%
Neutrophil count decreased
18%
Arthralgia
18%
Peripheral sensory neuropathy
18%
Hypokalaemia
18%
Oral candidiasis
18%
Weight decreased
18%
Lethargy
12%
Flushing
12%
Superficial vein thrombosis
12%
Paraesthesia
12%
Blood alkaline phosphatase increased
12%
Abdominal pain
12%
Dizziness
12%
Abdominal discomfort
12%
Colitis
12%
Vomiting
12%
Rectal haemorrhage
12%
Gastrooesophageal reflux disease
12%
Pain in extremity
12%
Infusion related reaction
12%
Alanine aminotransferase increased
12%
Cough
6%
Rash
6%
Upper respiratory tract infection
6%
Cytomegalovirus infection reactivation
6%
Thrombosis
6%
Rash maculo-papular
6%
Pain in jaw
6%
Orthostatic hypotension
6%
Squamous cell carcinoma
6%
Vision blurred
6%
Abdominal distension
6%
Abdominal tenderness
6%
Tumour lysis syndrome
6%
Back pain
6%
Hypocalcaemia
6%
Hypertension
6%
Cellulitis
6%
Neutropenic sepsis
6%
Transient ischaemic attack
6%
Chest pain
6%
Aspartate aminotransferase increased
6%
Blood creatinine increased
6%
Adenocarcinoma
6%
Oropharyngeal pain
6%
Groin pain
6%
Abdominal pain lower
6%
Anal haemorrhage
6%
Performance status decreased
6%
Hypogammaglobulinaemia
6%
Seasonal allergy
6%
Urinary tract infection
6%
Gamma-glutamyltransferase increased
6%
Hyperlipidaemia
6%
External ear cellulitis
6%
Decreased appetite
6%
Hyperglycaemia
6%
Epistaxis
6%
Depression
6%
Photosensitivity reaction
6%
Injury
6%
Wound infection
6%
Hypoalbuminaemia
6%
Dyspnoea exertional
6%
Intention tremor
6%
Throat irritation
6%
Vasospasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Glofit-GemOx
Arm B: Mosun-GemOx
Trial Design
2Treatment groups
Experimental Treatment
Group I: Non-fractionated/Dose-findingExperimental Treatment2 Interventions
Participants will receive a single dose of mosunetuzumab.
Group II: Fractionated/Dose-escalationExperimental Treatment2 Interventions
Participants will receive a fractionated (divided) dose of mosunetuzumab on Days 1 and 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
2019
Completed Phase 2
~140
Tocilizumab
2012
Completed Phase 4
~1840
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,090,083 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,800 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to follow the birth control requirements while on MMF.I was diagnosed with lupus more than 12 weeks ago.I have had symptoms of mixed connective tissue disease or systemic sclerosis in the last year.I do not have HIV, hepatitis, TB, or other serious infections.I haven't had cancer, major surgery recently, or plan to have surgery soon.I am allergic or cannot tolerate the study's drugs or their components.My tests show SLE autoantibodies like ANA, anti-dsDNA, or anti-Sm.My lupus has caused serious kidney problems.I am currently on stable doses of medication for lupus.I have had severe antiphospholipid syndrome in the last year.I have severe or unstable lupus affecting my nervous system.My lupus is active, with a score of 4 or higher.I am at high risk for serious bleeding or need treatment for certain conditions.I haven't taken any experimental drugs within the last 30 days or 5 half-lives before starting the study treatment.I have not taken specific immune or cancer treatments listed.
Research Study Groups:
This trial has the following groups:- Group 1: Non-fractionated/Dose-finding
- Group 2: Fractionated/Dose-escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Mosunetuzumab been endorsed by the FDA?
"The safety of Mosunetuzumab was rated a 1 by our team here at Power because this is only in the first stage of clinical trials, meaning there is scant evidence on its efficacy and security."
Answered by AI
Have any prior experiments utilized Mosunetuzumab?
"Currently, 76 trials involving Mosunetuzumab are underway; nine of those studies have advanced to Phase 3. Many of which originate in Poznan and New york City with a total of 1,671 clinical sites engaging in this research."
Answered by AI
What pathologies is Mosunetuzumab primarily indicated for?
"A range of autoimmune diseases, including cytokine release syndrome from car-t cell therapy, rheumatoid arthritis and polyarticular juvenile idiopathic arthritis can be managed with the usage of Mosunetuzumab."
Answered by AI
Is enrollment still possible for this experiment?
"This medical trial, which was initially launched on 1/11/2022, is actively seeking participants. The listing of this clinical study has been recently updated on 11/21/2022 according to information provided by clinicaltrials.gov."
Answered by AI
How many participants are included in the current trial?
"Affirmative. According to information available on clinicaltrials.gov, recruitment for this medical study is currently ongoing, having been first posted on January 11th 2022 and the most recent update being November 21st 2022. The trial requires 50 participants from two separate sites."
Answered by AI
Are there any prerequisites for becoming a participant in this research project?
"This clinical trial is seeking 50 individuals with Libman-Sacks Disease between the ages of 18 and 75. Those who meet these criteria will be eligible for consideration in this study."
Answered by AI
Is geriatric eligibility criteria still applicable for this experiment?
"This medical trial seeks to recruit patients aged 18-75. There are 27 studies catering exclusively to minors and 175 investigations presented for seniors."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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