Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABBV-382
Trosunilimab · 2 trials · 2 indications
Cmax of trosunilimab
Tmax of trosunilimab
Cwk4 of trosunilimab
AUC0-4wk of trosunilimab
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with the treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either "Reasonable Possibility" or "No Reasonable Possibility" and will assess the severity of each adverse event from Grade 1 (mild) to Grade 4 (potentially life-threatening).
Maximum observed serum concentration (Cmax) of ABBV-382.
Time to Cmax (Tmax) of ABBV-382.
Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-382.
AUC from time 0 to infinite time (AUCinf) of ABBV-382.
Terminal phase elimination rate constant of ABBV-382.
Terminal phase elimination half-life of ABBV-382.
Observed concentration at the end of the 4-week dosing interval (Ctrough) of ABBV-382.
AUC during the 4-week dosing interval (AUCtau) of ABBV-382.
Terminal phase elimination half-life (t1/2) of ABBV-382 will be estimated after the third dose only.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Trosunilimab IV | ACTIVE_COMPARATOR | Participants will receive an intravenous (IV) trosunilimab dose |
| Arm 2: Trosunilimab SC | ACTIVE_COMPARATOR | Participants will receive subcutaneous (SC) injection doses of trosunilimab |
| Part A: ABBV-382 Dose A | EXPERIMENTAL | Participants will receive intravenous (IV) ABBV-382 dose A on Day 1. |
| Part A: ABBV-382 Dose B | EXPERIMENTAL | Participants will receive intravenous (IV) ABBV-382 dose B on Day 1. |
| Part B: Intravenous Cohort: ABBV-382 Dose A | EXPERIMENTAL | Participants will receive intravenous (IV) ABBV-382 dose A on Days 1, 29 and 57. |
| Part B: Intravenous Cohort: Placebo for ABBV-382 Dose A | PLACEBO_COMPARATOR | Participants will receive intravenous (IV) placebo for ABBV-382 dose A on Days 1, 29 and 57. |
| Part B: Intravenous Cohort: ABBV-382 Dose B | EXPERIMENTAL | Participants will receive intravenous (IV) ABBV-382 dose B on Days 1, 29 and 57. |
| Part B: Intravenous Cohort: Placebo for ABBV-382 Dose B | PLACEBO_COMPARATOR | Participants will receive intravenous (IV) placebo for ABBV-382 dose B on Days 1, 29 and 57. |
| Part B: Subcutaneous Cohort: ABBV-382 | EXPERIMENTAL | Participants will receive subcutaneous (SC) ABBV-382 dose C on Days 1, 29 and 57. |
| Name | Type | Description |
|---|---|---|
| Trosunilimab | DRUG | Subcutaneous (SC) Injection |
| ABBV-382 | DRUG | Intravenous (IV) infusion |
| Placebo for ABBV-382 | DRUG | Intravenous (IV) infusion |
Inclusion Criteria: * Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement. * Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in mete...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Duvakitug, Brivekimig |
| AbbVie, Inc. | ABBV | 16 | PHASE3 | Upadacitinib, Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736 |
| Eli Lilly and Company | LLY | 7 | PHASE3 | Mirikizumab, Tirzepatide, LY4395089, MORF-057 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 15 | PHASE3 | Vedolizumab, Zasocitinib, Darvadstrocel |
| Johnson & Johnson | JNJ | 24 | PHASE3 | Guselkumab, Ustekinumab, Icotrokinra, JNJ-78934804, Golimumab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| Spyre Therapeutics, Inc | SYRE | 2 | PHASE2 | SPY001, SPY002, SPY003 |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Shattuck Labs, Inc. | STTK | 1 | PHASE2 | SL-325 |
| AgomAb Therapeutics NV ADR | AGMB | 2 | PHASE2 | Ontunisertib |
| Hoffmann-La Roche | RHHBY | 1 | PHASE2 | Afimkibart |
| Pfizer Inc. | PFE | 1 | PHASE2 | Etrasimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
Trosunilimab is an investigational antibody-based biologic being developed by AbbVie Inc. for Crohn's disease. It is in Phase 1 clinical development and has not been approved for any use. Its only listed clinical study to date is a Phase 1 trial in healthy adult volunteers.
Trosunilimab is being developed as a treatment for Crohn's disease, an inflammatory bowel condition. It is investigational and has not been approved for Crohn's disease or any other indication. The only trial listed for trosunilimab enrolled healthy volunteers rather than patients with Crohn's disease.
Trosunilimab is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the drug's clinical program, which currently consists of a single Phase 1 study conducted in the United States.
Trosunilimab is in Phase 1 clinical development. It is an investigational biologic and is not FDA approved. The program currently has one Phase 1 trial, which is recruiting, and no completed trials. That study is designed to enroll about 60 participants.
Trosunilimab is being studied in one Phase 1 trial, NCT07925983, titled a study to assess how intravenous and subcutaneous administrations of trosunilimab move through the body of healthy adult participants. The trial is recruiting in the United States, targets about 60 healthy volunteers aged 18 and older, and is active controlled and randomized.