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ABBV-744 · 1 trial · 1 indication
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
| Arm | Type | Description |
|---|---|---|
| Segment A: ABBV-744 Dose Identification and Optimization | EXPERIMENTAL | Participants who have been previously treated with Janus Kinase inhibitor(s) (JAKi) and stopped such therapy, will receive different dosing regimens and schedules of ABBV-744 to identify the safe dosing regimen and schedule. |
| Segment A: ABBV-744 Monotherapy | EXPERIMENTAL | Participants will receive the identified safe dosing regimen of ABBV-744 as monotherapy. |
| Segment B: Ruxolitinib + ABBV-744 "Add on" Therapy | EXPERIMENTAL | Participants whose disease (myelofibrosis) is inadequately controlled by ongoing ruxolitinib therapy will receive ruxolitinib and ABBV-744 as "add-on" therapy. |
| Segment C: ABBV-744 + Navitoclax | EXPERIMENTAL | Participants who have previously been exposed to JAKi, and stopped such therapy, will receive ABBV-744 and navitoclax. |
| Segment D: ABBV-744 + Ruxolitinib | EXPERIMENTAL | Participants who have never received JAKi will receive ABBV-744 and ruxolitinib. |
| Name | Type | Description |
|---|---|---|
| ABBV-744 | DRUG | Tablet; Oral |
| Navitoclax | DRUG | Tablet; Oral |
| Ruxolitinib | DRUG | Tablet; Oral |
Inclusion Criteria: * Laboratory values indicative of adequate bone marrow, renal, and hepatic function meeting protocol criteria. * Completion of the Myelofibrosis System Assessment Form (MFSAF) on at least 4 out of the 7 days prior to Day 1 with at least 2 symptoms with a score \>=3 or a total sc...
ABBV-744 is an investigational small molecule being studied for the treatment of myelofibrosis (MF), a type of bone marrow cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated for its safety and tolerability in adult participants with this condition.
ABBV-744 targets BET proteins, which are involved in regulating gene expression. By inhibiting BET proteins, the drug may interfere with pathways that drive the growth of cancer cells in myelofibrosis. This mechanism is being explored in early-stage clinical trials to understand its potential therapeutic effects.
ABBV-744 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with myelofibrosis.
ABBV-744 is in Phase 1 clinical development. This early-stage trial is designed to assess the safety, tolerability, and pharmacokinetics of the drug in adult participants with myelofibrosis. The drug is investigational and has not yet received regulatory approval for any indication.
ABBV-744 is being studied in a Phase 1 clinical trial with the identifier NCT04454658. This trial evaluates the safety and tolerability of oral ABBV-744 alone or in combination with ruxolitinib or navitoclax in adult participants with myelofibrosis. The study is active but not recruiting and has an enrollment of 21 participants.
No, ABBV-744 is a distinct investigational drug being developed by AbbVie. Ruxolitinib and navitoclax are separate medications that are being studied in combination with ABBV-744 in clinical trials for myelofibrosis. ABBV-744 targets BET proteins, while ruxolitinib and navitoclax have different mechanisms of action.