- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05393999
SABRE: A Single-arm Prospective Study Measuring Safety and Tolerability of SARS-CoV-2 Neutralising Antibodies in High-risk Populations (SABRE)
The SABRE Trial: A Single-arm Prospective Study Measuring Safety, Tolerability and Pharmacokinetics of Two SARS-CoV-2 Neutralising Antibodies (C135-LS and C144-LS) Amongst High-risk Special Populations of Vaccine Non-responders.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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London, United Kingdom
- Imperial College Heathcare NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged ≥18 years old at screening;
- Able to give informed written consent including consent to long-term follow-up;
- Willing and able to comply with visit schedule and provide blood sampling;
Have received at least two doses of a routine NHS standard of care SARS-Cov-2 vaccine and do not have detectable serum SARS-CoV-2 anti-spike antibodies in routine NHS assays > two weeks post 2nd vaccination, including:
- Solid organ transplant recipients;
- People with specific haematological diseases;
- People undergoing active chemotherapy, having immunotherapy or other continuing antibody or targeted therapy that affect immune system;
- People with cancers of the blood or bone marrow such as leukaemia, lymphoma or myeloma who are at any stage of treatment;
- People who have had bone marrow or stem cell transplants in the last 6 months or who are still taking immunosuppression drugs;
- People who are receiving long-term immune suppression therapy for ny other condition
Be ineligible to receive a SARS-CoV-2 prophylactic vaccine for any of the following reasons:
- The need to commence immediate systemic chemotherapy;
- The need to receive a bone-marrow and therefore the requirement to initiate profound immune suppression
- Have an estimated life expectancy of > 12 weeks;
Females capable of becoming pregnant* must agree to use hormonal contraception, intrauterine device, intrauterine hormone-releasing system, or to complete abstinence** from at least four weeks before the first antibody injection and for 20 months after the last antibody injection
- Females capable of becoming pregnant are defined as: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
**Complete abstinence (defined as refraining from heterosexual intercourse) must be in line with the preferred and usual lifestyle of the participant. Barrier contraception, periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods), withdrawal and progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action are not acceptable methods of contraception.
Exclusion Criteria:
- Current SARS-CoV-2 infection confirmed by SARS-CoV-2 RT-PCR positive result from nasopharyngeal swab within the past 10 days and up to 24 hours prior to enrolment;
- Participation in any other clinical trial of an experimental agent or any non-interventional study where additional blood draws are required; participation in observational studies is permitted. Patients in survival follow up of another clinical trial of an investigational medicinal product (CTIMP) study may be considered if more than 5 half lives have passed since last CTIMP treatment and with permission of the medical monitor for the other study;
- History of anaphylaxis or severe adverse reaction to antibody injections, or hypersensitivity to neutralising antibodies or to any constituent products or excipients thereof;
- Treatment with intravenous immunoglobulin (IVIG) or other investigational treatments planned during the duration of the trial;
Clinically significant abnormal blood test results at screening including:
- Moderate to severe hepatic impairment as defined by Child-Pugh classification;
- ALT >5 x ULN;
- INR >1.5
- Pregnancy or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BMS-986414 and BMS-986413
|
Broadly neutralising antibodies BMS-986414
Other Names:
Broadly neutralising antibodies BMS-986413
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experience at least one Adverse Event of Interest (AEI).
Time Frame: Week 12
|
Number and proportion of participants who experience at least one AEI.
The total number of AEIs (where multiple events per individual are counted) will also be reported.
|
Week 12
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Experience at least one Serious Adverse Event (SAE).
Time Frame: Week 12
|
Number and proportion of participants who experience at least one SAE.
The total number of SAEs (where multiple events per individual are counted) will also be reported.
|
Week 12
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Antibody level of BMS-986414 in plasma/serum, measured using the PK assay.
Time Frame: Week 12
|
This will be summarised using the mean, alongside an appropriate measure of variability, anticipated to be 95% confidence interval.
|
Week 12
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Antibody level of BMS-986413 in plasma/serum, measured using the PK assay.
Time Frame: Week 12
|
This will be summarised using the mean, alongside an appropriate measure of variability, anticipated to be 95% confidence interval.
|
Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion achieving antibody levels of BMS-986414 in plasma/serum [measured using the PK assay] above the target PK threshold (2 ug/mL).
Time Frame: Weeks 1, 4, 8, 12, 24
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Number and unadjusted proportion with a corresponding 95% CI.
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Weeks 1, 4, 8, 12, 24
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Proportion achieving antibody levels of BMS-986413 in plasma/serum [measured using the PK assay] above the target PK threshold (2 ug/mL).
Time Frame: Weeks 1, 4, 8, 12, 24
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Number and unadjusted proportion with a corresponding 95% CI.
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Weeks 1, 4, 8, 12, 24
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Antibody levels of BMS-986414 in plasma/serum measured using the PK assay.
Time Frame: Weeks 1, 4, 8, 24
|
Mean levels will be plotted against time point, alongside an appropriate measure of variability, anticipated to be 95% confidence interval.
|
Weeks 1, 4, 8, 24
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Antibody levels of BMS-986413 in plasma/serum at measured using the PK assay.
Time Frame: Weeks 1, 4, 8, 24
|
Mean levels will be plotted against time point, alongside an appropriate measure of variability, anticipated to be 95% confidence interval.
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Weeks 1, 4, 8, 24
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Antibody levels of BMS-986414 in plasma/serum measured by NHS assay.
Time Frame: Weeks 1, 4, 8 12, 18, 24, 32, 40, 48
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Mean levels will be plotted against time point, alongside an appropriate measure of variability, anticipated to be 95% confidence interval.
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Weeks 1, 4, 8 12, 18, 24, 32, 40, 48
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Antibody levels of BMS-986413 in plasma/serum measured by NHS assay
Time Frame: Weeks 1, 4, 8 12, 18, 24, 32, 40, 48
|
Mean levels will be plotted against time point, alongside an appropriate measure of variability, anticipated to be 95% confidence interval.
|
Weeks 1, 4, 8 12, 18, 24, 32, 40, 48
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Experience at least one Adverse Event of Interest (AEI)
Time Frame: Day 400
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Number and proportion of participants who experience at least one AEI.
The total number of AEIs (where multiple events per individual are counted) will also be reported.
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Day 400
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Experience at least one Serious Adverse Event (SAE)
Time Frame: Day 400
|
Number and proportion of participants who experience at least one AEI.
The total number of AEIs (where multiple events per individual are counted) will also be reported.
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Day 400
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lucy Cook, Imperial College NHS Trust London
- Principal Investigator: Andy Peniket, Oxford University Hospitals NHS Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Autoimmune Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombophilia
- Thrombotic Microangiopathies
- COVID-19
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombotic Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
Other Study ID Numbers
- 21HH6747
- 2021-003033-10 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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