A Study to Investigate the Safety and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Male and Female Participants Aged 18 to 75 With Autoimmune Disease

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 stable but active autoimmune disease.

Conditions

Autoimmune Diseases

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Study Overview

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Study Details

Study overview

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 stable but active autoimmune disease.

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 Autoimmune Disease

A Study to Investigate the Safety and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Male and Female Participants Aged 18 to 75 With Autoimmune Disease

Condition
Autoimmune Diseases
Intervention / Treatment

-

Contacts and Locations

Medley

GSK Investigational Site, Medley, Florida, United States, 33166

Peachtree Corners

GSK Investigational Site, Peachtree Corners, Georgia, United States, 30071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Body mass index (BMI) from 18 to 40 kilograms per square meter (kg/m\^2) (BMI = weight/height\^2), inclusive, and body weight of \>=40 kilogram (kg)
  • * IgM \>= lower limit of normal (LLN) (40 milligram per deciliter \[mg/dL\]) at initial screening visit (ISV).
  • * 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
  • * RA functional status class IV according to the ACR 1991 revised criteria
  • * Adult Juvenile RA
  • * Acute thrombosis (arterial or venous acute thrombosis diagnosis less than 30 days before study ISV)
  • * Catastrophic APS classification within the prior 90 days of ISV

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

GlaxoSmithKline,

GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

2025-11-27