RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06-03
Study Completion:2025-11-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06413511

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * IgM \>= lower limit of normal (LLN) (40 milligram per deciliter \[mg/dL\]) at initial screening visit (ISV).
  1. * Any acute, severe lupus related flare during the Screening Period that needs immediate treatment
  2. * Has any unstable or progressive manifestation of SLE
  3. * Significant, likely irreversible organ damage related to SLE
  4. * RA functional status class IV according to the ACR 1991 revised criteria
  5. * Adult Juvenile RA
  6. * Acute thrombosis (arterial or venous acute thrombosis diagnosis less than 30 days before study ISV)
  7. * Catastrophic APS classification within the prior 90 days of ISV

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center
CONTACT
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
CONTACT
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com

Principal Investigator

GSK Clinical Trials
STUDY_DIRECTOR
GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site
Medley, Florida, 33166
United States
GSK Investigational Site
Peachtree Corners, Georgia, 30071
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

  • GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-03
Study Completion Date2025-11-27

Study Record Updates

Study Start Date2024-06-03
Study Completion Date2025-11-27

Terms related to this study

Keywords Provided by Researchers

  • Systemic Lupus Erythematosus
  • Belantamab (GSK2857914)
  • Autoimmune Disease

Additional Relevant MeSH Terms

  • Autoimmune Diseases