Investigating the safety of belantamab in patients with autoimmune diseases
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
This study tests if a new drug called belantamab is safe for adults with autoimmune diseases like lupus and rheumatoid arthritis who haven't found relief from other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Drugs / interventions | belantamab |
| Locations | 5 sites (Medley, Florida and 4 other locations) |
| Trial ID | NCT06413511 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and pharmacological effects of a single intravenous infusion of belantamab in participants aged 18 to 75 with stable but active autoimmune diseases. The study will monitor how the levels of belantamab change over time and assess the body's reaction to the drug. Participants will be closely observed for any adverse effects and overall tolerability of the treatment. The trial specifically targets individuals with systemic lupus erythematosus and rheumatoid arthritis who have not adequately responded to previous therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with a documented diagnosis of systemic lupus erythematosus or rheumatoid arthritis who have failed previous immunosuppressive therapies.
Not a fit: Patients with autoimmune diseases who have not been diagnosed with systemic lupus erythematosus or rheumatoid arthritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with autoimmune diseases who have limited responses to existing treatments.
How similar studies have performed: Other studies have shown promise with similar approaches in treating autoimmune diseases, but the specific use of belantamab in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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) Participants with systemic lupus erythematosus (SLE) must also meet the following inclusion criteria: * Documented clinical diagnosis of SLE according to the European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria * Positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) autoantibody and/or positive antinuclear antibody (ANA) test results, using central lab test, at ISV. * SLE Disease Activity Index 2000 (SLEDAI-2K) total score of \>=6 at ISV. * Failure to adequately respond to at least two immunosuppressive therapies. Participants with Rheumatoid Arthritis (RA) must also meet the following inclusion Criteria: * Meets ACR/EULAR 2010 RA Classification Criteria with a duration of RA disease of \>=6 months at time of ISV * Positive rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) test results, using central lab test, at ISV. * Have moderate to severe active disease as defined by \>=3/68 Tender and \>=3/66 Swollen joint count at ISV and Baseline. * Failure to adequately respond to at least two immunosuppressive therapies. Participants with antiphospholipid syndrome (APS) must also meet the following inclusion criteria: * Documented diagnosis of APS meeting the 2023 ACR/EULAR APS classification criteria * Positive lupus anticoagulant test or moderate to high titers of positive IgG/IgM anticardiolipin (aCL) or moderate to high titers of IgG/IgM anti-beta2-glycoprotein I antibody using central lab test, at ISV * Clinical features attributable to antiphospholipid antibodies that are resistant to warfarin and/or heparin: * Thrombotic event within last 18 months despite adequate anti-coagulation therapy and/or * Persistent thrombocytopenia and/or * Persistent autoimmune hemolytic anemia * Sex and Contraceptive /Barrier requirements for females. Exclusion criteria: SLE specific exclusion: * 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 specific exclusions: * RA functional status class IV according to the ACR 1991 revised criteria * Adult Juvenile RA APS specific exclusions: * 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
Where this trial is running
Medley, Florida and 4 other locations
- GSK Investigational Site — Medley, Florida, United States (Recruiting)
- GSK Investigational Site — Peachtree Corners, Georgia, United States (Recruiting)
- GSK Investigational Site — Bordeaux, France (Recruiting)
- GSK Investigational Site — Madrid, Spain (Recruiting)
- GSK Investigational Site — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.