SARS-CoV2 InfectionPhase 2SABRENCT05393999

SABRE: A Single-arm Prospective Study Measuring Safety and Tolerability of SARS-CoV-2 Neutralising Antibodies in High-risk Populations

A Phase 2 study testing BMS-986414 and BMS-986413 in people with SARS-CoV2 Infection and SARS-CoV-2 Acute Respiratory Disease, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: SARS-CoV2 Infection, SARS-CoV-2 Acute Respiratory Disease, Myeloma
What is being tested?: BMS-986414 and BMS-986413
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited Kingdom
Study dates: 29 Nov 2021to 4 Mar 2022
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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;

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ALT >5 x ULN;
INR >1.5
Pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Imperial College Heathcare NHS Trust
London

Other trials in United Kingdom

About this study

Official title: 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.

The SABRE study is a single-arm prospective study measuring safety, tolerability and pharmacokinetics of two SARS-CoV-2 neutralising antibodies (BMS-986414 and BMS-986413) amongst high-risk special populations of vaccine non-responders. The aim is to test the hypothesis that for individuals who fail to mount a measurable immune response to a routinely offered SARS-CoV-2 prophylactic vaccine or for those who are not able to receive such a vaccine (for example those receiving a bone marrow transplant or starting chemotherapy treatment), the receipt of subcutaneous injection of two long-acting neutralising antibodies BMS-986414 and BMS-986413 will confer durable high titres and subsequent immunological protection against SARS-CoV-2 infection.120 eligible participants will be enrolled and followed up for 48 weeks after the one-time dosing visit. Primary inclusion criteria are patients age 18 years and older and either 1) have received 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 more than two weeks post-vaccination, or do not have protective levels of antibody or 2) be ineligible to receive a SARS-CoV-2 prophylactic vaccine. This could be because they need to commence immediate systemic chemotherapy or receive bone marrow and therefore the requirement to initiate profound immune suppression. Primary objectives are to determine the safety, tolerability and detectable SARS-CoV-2 antibody by specific PPD assay in serum at 12 weeks after enrolment.

Conditions: SARS-CoV2 Infection, SARS-CoV-2 Acute Respiratory Disease, Myeloma, Leukemia, Lymphoma, Immune Thrombocytopenia
Being tested: BMS-986414, BMS-986413
Medical subject headings: COVID-19, Neoplasms, Plasma Cell, Leukemia, Lymphoma, Purpura, Thrombocytopenic, Idiopathic, Purpura, Thrombotic Thrombocytopenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMS-986414Biological
Also called C135-LS
Broadly neutralising antibodies BMS-986414
BMS-986413Biological
Also called C144-LS
Broadly neutralising antibodies BMS-986413

Study groups in NCT05393999
Study group	Role	What they receive
BMS-986414 and BMS-986413	Experimental	1. Broadly neutralising antibody:BMS-986414 This long-acting antibody will be prescribed to all participants and given as one subcutaneous injection of 200 mg. 2. Broadly neutralising antibody: BMS-986413 This long-acting antibody will be prescribed to all participants and given as one subcutaneous injection of 200 mg Receives: Biological: BMS-986414; Biological: BMS-986413

What is being measured

The primary outcome is the main question the study is designed to answer.

Experience at least one Adverse Event of Interest (AEI).
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.
Measured: Week 12
Experience at least one Serious Adverse Event (SAE).
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.
Measured: Week 12
Antibody level of BMS-986414 in plasma/serum, measured using the PK assay.
This will be summarised using the mean, alongside an appropriate measure of variability, anticipated to be 95% confidence interval.
Measured: Week 12
Antibody level of BMS-986413 in plasma/serum, measured using the PK assay.
This will be summarised using the mean, alongside an appropriate measure of variability, anticipated to be 95% confidence interval.
Measured: Week 12

Secondary outcomes (8)

Proportion achieving antibody levels of BMS-986414 in plasma/serum [measured using the PK assay] above the target PK threshold (2 ug/mL).
Number and unadjusted proportion with a corresponding 95% CI.
Measured: Weeks 1, 4, 8, 12, 24
Proportion achieving antibody levels of BMS-986413 in plasma/serum [measured using the PK assay] above the target PK threshold (2 ug/mL).
Number and unadjusted proportion with a corresponding 95% CI.
Measured: Weeks 1, 4, 8, 12, 24
Antibody levels of BMS-986414 in plasma/serum measured using the PK assay.
Mean levels will be plotted against time point, alongside an appropriate measure of variability, anticipated to be 95% confidence interval.
Measured: Weeks 1, 4, 8, 24
Antibody levels of BMS-986413 in plasma/serum at measured using the PK assay.
Mean levels will be plotted against time point, alongside an appropriate measure of variability, anticipated to be 95% confidence interval.
Measured: Weeks 1, 4, 8, 24
Antibody levels of BMS-986414 in plasma/serum measured by NHS assay.
Mean levels will be plotted against time point, alongside an appropriate measure of variability, anticipated to be 95% confidence interval.
Measured: Weeks 1, 4, 8 12, 18, 24, 32, 40, 48
Antibody levels of BMS-986413 in plasma/serum measured by NHS assay
Mean levels will be plotted against time point, alongside an appropriate measure of variability, anticipated to be 95% confidence interval.
Measured: Weeks 1, 4, 8 12, 18, 24, 32, 40, 48
Experience at least one Adverse Event of Interest (AEI)
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.
Measured: Day 400
Experience at least one Serious Adverse Event (SAE)
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.
Measured: Day 400

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 20214 Mar 2022

First posted27 May 2022
Study start29 Nov 2021
Primary completion4 Mar 2022
Study completion4 Mar 2022

Why it stopped: The drug was found to be ineffective against Omicron, so the study was terminated and no patients were enrolled.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05393999
Sponsor's protocol ID: 21HH6747
Other IDs: 2021-003033-10
Acronym: SABRE
Status last verified: Apr 2023
First submitted: 1 Sep 2021
Last updated: 24 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT05393999
Acronym / sponsor ID: SABRE / 21HH6747
Conditions: SARS-CoV2 Infection, SARS-CoV-2 Acute Respiratory Disease, Myeloma, Leukemia, Lymphoma, Immune Thrombocytopenia
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The drug was found to be ineffective against Omicron, so the study was terminated and no patients were enrolled.
Enrolment: 0 participants (actual)
Lead sponsor: Imperial College Healthcare NHS TrustUniversity, hospital or other
Collaborators: Imperial College London, University of Oxford, Oxford University Hospitals NHS Trust
Study start: 29 Nov 2021 (actual)
Primary completion: 4 Mar 2022 (actual)
Study completion: 4 Mar 2022 (actual)
First posted: 27 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BMS-986414 and BMS-986413	Experimental	Biological: BMS-986414, Biological: BMS-9864131. Broadly neutralising antibody:BMS-986414 This long-acting antibody will be prescribed to all participants and given as one subcutaneous injection of 200 mg. 2. Broadly neutralising antibody: BMS-986413 This long-acting antibody will be prescribed to all participants and given as one subcutaneous injection of 200 mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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:
Be ineligible to receive a SARS-CoV-2 prophylactic vaccine for any of the following reasons:

Key exclusion criteria (9 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BMS-986414Also: C135-LSBroadly neutralising antibodies BMS-986414	Biological	BMS-986414 and BMS-986413
BMS-986413Also: C144-LSBroadly neutralising antibodies BMS-986413	Biological	BMS-986414 and BMS-986413

Primary outcome

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.
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.
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.
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.

8 secondary outcomes

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
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
Antibody levels of BMS-986414 in plasma/serum measured using the PK assay.
Time frame: Weeks 1, 4, 8, 24
Antibody levels of BMS-986413 in plasma/serum at measured using the PK assay.
Time frame: Weeks 1, 4, 8, 24
Antibody levels of BMS-986414 in plasma/serum measured by NHS assay.
Time frame: Weeks 1, 4, 8 12, 18, 24, 32, 40, 48
Antibody levels of BMS-986413 in plasma/serum measured by NHS assay
Time frame: Weeks 1, 4, 8 12, 18, 24, 32, 40, 48
Experience at least one Adverse Event of Interest (AEI)
Time frame: Day 400
Experience at least one Serious Adverse Event (SAE)
Time frame: Day 400

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lucy Cook principal investigator

Imperial College NHS Trust London

Andy Peniket principal investigator

Oxford University Hospitals NHS Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Experience at least one Adverse Event of Interest (AEI). (time frame: Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05393999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.