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VIB7734 · 2 trials · 7 indications
A BICLA response required improvement in all domains affected at baseline, assessed by the BILAG 2004, no worsening of other BILAG 2004 domains, no worsening of SLEDAI-2K or PGA scores compared with baseline, no use of restricted medications beyond the protocol-allowed threshold, and no discontinuation of IP.
| Arm | Type | Description |
|---|---|---|
| VIB7734 SC (dosing interval 1) | EXPERIMENTAL | - |
| VIB7734 SC (dosing interval 2) | EXPERIMENTAL | - |
| Placebo SC (dosing interval 3) | PLACEBO_COMPARATOR | - |
| Cohort 1: VIB7734 Dose 1 | EXPERIMENTAL | Participants will receive VIB7734 Dose 1 via injection q4w for a total of 3 doses on Days 1, 29, and 57. |
| Cohort 2: VIB7734 Dose 2 | EXPERIMENTAL | Participants will receive VIB7734 Dose 2 via injection q4w for a total of 3 doses on Days 1, 29, and 57. |
| Cohort 3: VIB7734 Dose 3 | EXPERIMENTAL | Participants will receive VIB7734 Dose 3 via injection q4w for a total of 3 doses on Days 1, 29, and 57. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to VIB7734 via injection q4w for a total of 3 doses on Days 1, 29, and 57. |
| Name | Type | Description |
|---|---|---|
| VIB7734 | DRUG | VIB7734 |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Age ≥ 18 years to ≤ 70 years * Willing and able to understand and provide written informed consent. * Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE * Disease duration of at least 6 months * Active SLE as in...
VIB7734 is an investigational small molecule being developed by Amgen Inc. for the treatment of Systemic Lupus Erythematosus (SLE). It has been studied in a Phase 2 clinical trial for moderate to severely active SLE, and in an earlier Phase 1 trial that also included cutaneous lupus erythematosus and other autoimmune conditions.
The molecular target of VIB7734 has not been disclosed in the available information. The drug is being studied for its effects in autoimmune diseases, but its specific mechanism of action is not publicly detailed.
VIB7734 is developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical trials to evaluate the drug's safety and efficacy in systemic lupus erythematosus and related autoimmune conditions.
VIB7734 is in Phase 2 clinical development for Systemic Lupus Erythematosus. A Phase 2 trial (NCT04925934) has been completed, and the drug remains investigational, meaning it is not yet approved by regulatory authorities. An earlier Phase 1 trial (NCT03817424) was also completed.
VIB7734 has been studied in two completed clinical trials. NCT03817424 was a Phase 1 study in participants with systemic lupus erythematosus, cutaneous lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis, and dermatomyositis. NCT04925934 was a Phase 2 study in moderate to severely active systemic lupus erythematosus.
VIB7734 is a distinct investigational drug developed by Amgen. It is not known to be the same as any other approved or investigational lupus therapy. Its unique characteristics and mechanism are not fully disclosed in available information.