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belantamab mafodotin to the existing stable standard background therapy · 1 trial · 1 indication
The change of serum anti-dsDNA antibody titers at 24 weeks of treatment compared to baseline will be summarized using descriptive statistics, including mean, standard deviation, median, percentiles and range. The analysis will be performed in the Response evaluable population. Change from baseline will be calculated as post-baseline value minus baseline value. The 95% confidence interval (CI) of the mean change will also be provided. To assess whether the median change from baseline is significantly different from zero, the Wilcoxon Signed-Rank Test will be used. A decrease of approximately 30 IU/mL in 50% of the patients in a JAK1/JAK2 inhibitor trial will be evaluated as significant.
| Arm | Type | Description |
|---|---|---|
| Single-arm trial, Open-label study, Overall, 12 participants will be enrolled in the trial. | OTHER | Non-randomized, open label assignment, No adaptive design specified, Planned Duration of trial intervention is 36 months. Participants will be treated for a total period of two years per participant or until treatment failure, physician decision, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). NOTE 1: The start of a Cycle1 D1 of a cycle is defined when Belantamab mafodotin is administered. |
| Name | Type | Description |
|---|---|---|
| belantamab mafodotin to the existing stable standard background therapy | DRUG | Trial treatment is defined as the addition of belantamab mafodotin to the existing stable standard background therapy. Belantamab mafodotin will be added to existing stable background SoC therapy, which can be GC, HCQ, or a single conventional immunosuppressive drug (such as azathioprine, methotrexate, or mycophenolate). For the purposes of this trial, belantamab mafodotin is considered an investigational medicinal product (IMP), while background SoC therapy regimen(s) is(are) considered auxiliary medicinal product(s) (AxMP). Background SoC therapy regimens should be authorized for use in the European Union and/or the country where the trial is taking place, and/or clearly endorsed/recommended by international treatment guidelines, if not otherwise authorized. Belantamab mafodotin is not authorized for use in the European Union. |
Inclusion Criteria 1. Diagnosis of SLE according to the 2019 EULAR/ACR SLE classification criteria. 2. Age between 18 and 60 years. 3. Have a body mass index (BMI) between 18 and 32 kg/m² (BMI = weight/height2), inclusive, and a body weight of no less than 35 kg. 4. Have a positive anti-dsDNA test ...
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Belantamab mafodotin is being studied as an add-on to existing stable standard background therapy in patients with previously treated systemic lupus erythematosus (SLE). The Phase 2 trial evaluates whether adding it to standard of care affects serum anti-dsDNA antibody titres in adults aged 18 and older.
GSK plc, which trades under the ticker GSK, is the developer of belantamab mafodotin. The company is sponsoring the Phase 2 study of the drug added to standard background therapy in previously treated systemic lupus erythematosus.
Belantamab mafodotin is in Phase 2 development for systemic lupus erythematosus. The single registered trial, NCT07844200, is a Phase 2 study that has not yet begun recruiting participants. It is an investigational agent and is not approved for SLE.
One trial is registered: NCT07844200, titled a study evaluating the effect of adding belantamab mafodotin to standard of care therapy on serum anti-dsDNA antibody titres in patients with previously treated SLE. It is a Phase 2, uncontrolled, non-randomized study with a planned enrollment of 12 adults, currently not yet recruiting.
The Phase 2 trial NCT07844200 plans to enroll 12 participants. It is an uncontrolled, non-randomized study open to all sexes, with a minimum age of 18 years. Healthy volunteers are not eligible, and the trial is not yet recruiting.
No. Belantamab mafodotin is investigational for systemic lupus erythematosus and remains in clinical development. The only registered SLE study, NCT07844200, is a Phase 2 trial that has not yet started recruiting, so the drug has no approval for this indication.