WithdrawnPhase 2

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

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

United Kingdom0Started 2021-11-29

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. The need to commence immediate systemic chemotherapy;
✓. The need to receive a bone-marrow and therefore the requirement to initiate profound immune suppression

Exclusion criteria

✕. Moderate to severe hepatic impairment as defined by Child-Pugh classification;

What they're measuring

Experience at least one Adverse Event of Interest (AEI).

Timeframe: Week 12

Experience at least one Serious Adverse Event (SAE).

Timeframe: Week 12

Antibody level of BMS-986414 in plasma/serum, measured using the PK assay.

Timeframe: Week 12

Antibody level of BMS-986413 in plasma/serum, measured using the PK assay.

Timeframe: Week 12

Trial details

NCT IDNCT05393999

SponsorImperial College Healthcare NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-04

View on ClinicalTrials.gov More SARS-CoV2 Infection trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. The need to commence immediate systemic chemotherapy;
✓. The need to receive a bone-marrow and therefore the requirement to initiate profound immune suppression

Exclusion criteria

✕. Moderate to severe hepatic impairment as defined by Child-Pugh classification;

What they're measuring

Experience at least one Adverse Event of Interest (AEI).

Timeframe: Week 12

Experience at least one Serious Adverse Event (SAE).

Timeframe: Week 12

Antibody level of BMS-986414 in plasma/serum, measured using the PK assay.

Timeframe: Week 12

Antibody level of BMS-986413 in plasma/serum, measured using the PK assay.

Timeframe: Week 12