Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tralokinumab Dose 1 · 1 trial · 1 indication
EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. |
| Tralokinumab Dose 1 | EXPERIMENTAL | Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks. |
| Tralokinumab Dose 2 | EXPERIMENTAL | Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks. |
| Tralokinumab Dose 3 | EXPERIMENTAL | Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Subcutaneous injection with placebo |
| Tralokinumab Dose 1 | BIOLOGICAL | Subcutaneous injection with tralokinumab |
| Tralokinumab Dose 2 | BIOLOGICAL | Subcutaneous injection with tralokinumab |
| Tralokinumab Dose 3 | BIOLOGICAL | Subcutaneous injection with tralokinumab |
Inclusion Criteria: * Physician diagnosis of atopic dermatitis for greater than (\>) 1 year * Atopic dermatitis involvement of greater than or equal to (\>=) 10 percent (%) body surface area * EASI score of \>= 12 * SCORAD of \>= 25 * IGA score of \>= 3 * Effective birth control in line with protoc...
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| Pfizer Inc. | PFE | 11 | PHASE3 | Abrocitinib |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Lebrikizumab, Corticosteroid |
| Sanofi SA Sponsored ADR | SNY | 13 | PHASE3 | Amlitelimab |
| Regeneron Pharmaceuticals, Inc. | REGN | 4 | PHASE3 | Dupilumab |
| Incyte Corporation | INCY | 3 | PHASE3 | Ruxolitinib, Vehicle |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof, 1%, Vehicle |
| Apogee Therapeutics, Inc. | APGE | 3 | PHASE2 | APG777 |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | GIA632 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
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| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE2 | Barzolvolimab |
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| Sunshine Biopharma Incorporated | SBFM | 3 | PHASE3 | 611, corticosteroid |
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| Q32 Bio Inc | QTTB | 1 | PHASE2 | ADX-914 |
| Turn Therapeutics Inc. | TTRX | 1 | PHASE2 | GX-03 |
| Arcutis Biotherapeutics Inc | ARQT | 1 | PHASE1 | ARQ-234 |
Tralokinumab is an investigational monoclonal antibody being studied for uncontrolled asthma, ulcerative colitis, asthma, and atopic dermatitis. It is developed by AstraZeneca PLC (AZN) and is currently in Phase 3 clinical development for these indications.
Tralokinumab is a monoclonal antibody that targets interleukin-13 (IL-13), a cytokine involved in inflammatory responses. By binding to IL-13, it aims to modulate the inflammatory pathways implicated in conditions like asthma and ulcerative colitis.
Tralokinumab is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the drug's efficacy and safety in respiratory and inflammatory conditions.
Tralokinumab is in Phase 3 clinical development. It has completed Phase 3 trials for uncontrolled asthma, and earlier phase trials have been completed for ulcerative colitis and asthma. The drug is investigational and not yet approved by regulatory authorities.
Tralokinumab has been studied in several clinical trials, including NCT02161757, a Phase 3 study in adults and adolescents with uncontrolled asthma, and NCT01482884, a Phase 2 study in patients with active, moderate-to-severe ulcerative colitis. Other trials include NCT01592396 and NCT02085473.
Yes, Tralokinumab is also known as CAT-354. In a Phase 1 study (NCT01592396), the drug was referred to as Tralokinumab (CAT-354), confirming that these names refer to the same investigational monoclonal antibody.