Clinical trial

A Phase 1b, Dose Escalation, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Participants With Moderate to Severe Systemic Lupus Erythematosus

Name

221615

Description

The goal of this clinical trial is to assess the safety and tolerability profile of belantamab. The study will also assess how the levels of belantamab change over time and body's reaction to it in participants with moderate to severe systemic lupus erythematosus (SLE).

Trial arms

Trial start

2024-05-29

Estimated PCD

2025-11-24

Trial end

2025-11-24

Status

Not yet recruiting

Phase

Early phase I

Treatment

Belantamab

Belantamab will be administered.

Arms:

Belantamab

Other names:

GSK2857914

Size

Primary endpoint

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Up to Week 12

Number of participants with clinically important findings in vital signs

Up to Week 12

Number of participants with clinically important findings in electrocardiogram

Up to Week 12

Number of participants with clinically important findings in echocardiogram

Up to Week 12

Number of participants with clinically important findings in haematology

Up to Week 12

Number of participants with clinically important findings in clinical chemistry

Up to Week 12

Number of participants with clinically important findings in urinalysis parameters

Up to Week 12

Number of participants with clinically important findings in corneal toxicity

Up to Week 12

Eligibility criteria

Inclusion Criteria: * Body mass index (BMI) from 18 to 32 kilograms per square meter (kg/m²) (BMI = weight/height\^2), inclusive, and body weight of ≥40 kg * Documented clinical diagnosis of SLE according to the European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria * Moderate to Severe SLE disease * Positive anti-dsDNA autoantibody test results * Sex and Contraceptive/Barrier requirements for males and females Exclusion Criteria: * Any acute, severe lupus related flare during the Screening Period that needs immediate treatment * Has any unstable or progressive manifestation of SLE * Significant, likely irreversible organ damage related to SLE * Major Diseases/Conditions/Morbidities including participants with any uncontrolled medical conditions (other than SLE) that in the opinion of the investigator puts the participant at unacceptable risk

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}

Updated at

2024-05-14

1 organization

1 product

1 indication

Organization

GlaxoSmithKline

Product

Belantamab

Indication

Systemic Lupus Erythematosus