Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Daxdilimab · 2 trials · 2 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.
| 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. |
| 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. |
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 the treatment of idiopathic inflammatory myositis and alopecia areata. It is in Phase 2 clinical development for these conditions. The drug is not approved and remains under investigation.
Daxdilimab is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being evaluated for its therapeutic effects in autoimmune-related skin and muscle conditions.
Daxdilimab is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Daxdilimab is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials for the drug are completed, and it is not currently in active trials.
Daxdilimab has been studied in two completed Phase 2 trials. NCT05368103 evaluated the drug in 30 participants with moderate-to-severe alopecia areata in the United States and Canada. NCT05669014 studied it in 12 participants with dermatomyositis or anti-synthetase inflammatory myositis across multiple countries.
No alternative names for Daxdilimab have been identified. It is referred to solely by its generic name in clinical trial records and development documentation.