Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HZN-7734, VIB7734
Daxdilimab · 4 trials · 9 indications
Total improvement score was derived from standardized clinical response criteria which was calculated by sum of improvement scores of 6 core set measures (CSMs) included physician global disease activity (PhGDA), patient global disease activity (PtGDA), manual muscle testing 8 (MMT8) bilateral, health assessment questionnaire-disability index (HAQ-DI), extramuscular global assessment (EGA), and laboratory muscle enzymes (LME). Total improvement score was ranged from 0 to 100, where higher scores indicated greater improvement. The TIS improvement categories are defined as minimal (TIS greater than or equal to \[≥\]20), moderate (TIS ≥40) and major improvement (TIS ≥60). Mean TIS at week 24 was reported in this outcome measure.
The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms. A decrease in SALT score from baseline indicated a reduction in AA symptoms. Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.
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 |
|---|---|---|
| Daxdilimab | EXPERIMENTAL | Daxdilimab will be administered by subcutaneous (SC) injection during the 24-week treatment period followed by an 8-week safety follow up. Prior to amendment 2 participants could enter an open-label extension period from weeks 24-48. For those participants already in the open-label extension, they will stop dosing and enter the safety follow up. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo will be administered by SC injection during the 24-week treatment period followed by an 8-week safety follow up. Prior to amendment 2 participants could enter an open-label extension period from weeks 24-48 and receive daxdilimab. For those participants already in the open-label extension, they will stop dosing and enter the safety follow up. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Daxdilimab | DRUG | Participants will be administered daxdilimab by subcutaneous (SC) injection. |
| Placebo | DRUG | Participants will be administered identically matching placebo by SC injection. |
| VIB7734 | DRUG | VIB7734 |
Key Inclusion Criteria: 1. Adult men or women 18 and ≤ 75 years of age at the time of signing the informed consent (ICF). 2. A diagnosis of definite or probable myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria: 1. Populatio...
Daxdilimab is an investigational monoclonal antibody being studied for alopecia areata and idiopathic inflammatory myositis, including dermatomyositis and anti-synthetase inflammatory myositis. It is in Phase 2 clinical development and has not been approved for any indication. Both studied conditions are immune-mediated disorders affecting the skin, hair, and muscle.
Daxdilimab targets LILRA4, also known as ILT7, a receptor found on plasmacytoid dendritic cells. It acts as an inhibitor of this target. By binding LILRA4, the antibody is designed to modulate the activity of these immune cells, which are implicated in interferon-driven inflammatory conditions such as alopecia areata and idiopathic inflammatory myositis.
Daxdilimab is being developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen holds the asset as part of its immunology pipeline. The company is responsible for the clinical program evaluating the antibody in immune-mediated and inflammatory conditions.
Daxdilimab is in Phase 2 clinical development. It is an investigational monoclonal antibody and has not received FDA approval for any indication. Two Phase 2 studies have been completed, one in alopecia areata and one in idiopathic inflammatory myositis, and no active trials are currently listed.
Daxdilimab has been evaluated in two completed Phase 2 trials. NCT05368103 studied the drug in moderate-to-severe alopecia areata across the United States and Canada with 30 participants. NCT05669014 was a Phase 2 proof of concept study in dermatomyositis or anti-synthetase inflammatory myositis, enrolling 12 participants across the United States, Brazil, Czechia, Mexico, Spain, and the United Kingdom.