Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ADX-914, bempikibart (ADX-914)
Bempikibart · 3 trials · 3 indications
Part A: Mean relative percent change in SALT score at 24 weeks compared with baseline
Part B: Mean percent change from baseline in SALT score at Week 36
Severity score is based on evaluation of severity of atopic dermatitis in 4 body regions (head and neck, trunk, upper limbs, and lower limbs). The minimum score is 0 (less severe) and maximum score is 72 (most severe).
Listing and summary of AE incidence
Listing of clinically significant changes in PE findings
Listing and change from baseline to end of study
Listing and change from baseline to end of study
Listing and change from baseline to end of study
Change in 12-lead ECG parameters from baseline to end of study
| Arm | Type | Description |
|---|---|---|
| Experimental: bempikibart (ADX-914) | EXPERIMENTAL | 200mg dose of bempikibart (ADX-914) administered via injection under the skin |
| ADX-914 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Experimental: Cohort 1:1 - 1:6 ADX-914 | EXPERIMENTAL | ADX-914 single SC dose |
| Placebo Comparator: Cohort 1:1 - 1:6 placebo | PLACEBO_COMPARATOR | Placebo single SC dose |
| Experimental: Cohort 2:1- 2:3 | EXPERIMENTAL | ADX-914 multiple SC dose once every 2 weeks for 6 weeks |
| Placebo Comparator: Cohort 2:1- 2:3 | PLACEBO_COMPARATOR | Placebo multiple SC dose once every 2 weeks for 6 weeks |
| Name | Type | Description |
|---|---|---|
| bempikibart (ADX-914) | DRUG | Subcutaneous administration of bempikibart (ADX-914) |
| ADX-914 | DRUG | Subcutaneous administration of ADX-914 |
| Placebo | DRUG | Subcutaneous administration of Placebo |
Key Inclusion Criteria: 1. Adult men and women, aged 18 to 75 years, inclusive, at the time of informed consent. 2. Clinical diagnosis of severe to very severe alopecia areata, defined as the presence of ≥50% total scalp hair loss at screening and baseline as measured by the SALT score. Key Exclus...
Bempikibart is an investigational small molecule being developed for the treatment of severe alopecia areata, a dermatologic condition. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in a proof-of-concept trial for this indication.
Bempikibart targets IL-7Rα, a protein involved in immune signaling. By targeting this receptor, the drug is designed to modulate immune responses relevant to alopecia areata. It is a small molecule therapeutic being investigated for its potential to treat severe forms of this condition.
Bempikibart is being developed by Q32 Bio Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with severe alopecia areata. Q32 Bio is advancing this asset through Phase 2 clinical development.
Bempikibart is currently in Phase 2 clinical development. It is being studied in a Phase 2a proof-of-concept trial for severe alopecia areata. The drug has received Fast Track designation from the FDA, but it remains investigational and is not yet approved for any use.
Bempikibart is being evaluated in a single active clinical trial, NCT06018428, titled 'A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)'. This trial is enrolling 75 participants in the United States and Canada and is currently active but not recruiting.
Yes, bempikibart is also known as ADX-914. The drug is referred to by both names in clinical research, with the Phase 2a trial using the name 'Bempikibart (ADX-914)' in its title. This alternative name may appear in scientific literature and trial registries.