Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
zetomipzomib · 1 trial · 1 indication
The number of patients who achieve complete biochemical response (CR), defined as normal ALT, AST, and IgG values (if IgG level is elevated at Baseline) with glucocorticoid dose not higher than starting dose (at Baseline), by Week 24 of the Double-Blind Treatment Period. Analyses were also conducted at Week 12, Week 16, and Week 20.
Proportion of participants who experience AEs (adverse events) and SAEs (serious adverse events) during the double-blind treatment period (DBTP) and the open-label extension (OLE).
Proportion of participants experiencing a disease flare among the participants who achieved a complete biochemical response (CR) during the double-blind treatment period.
| Arm | Type | Description |
|---|---|---|
| zetomipzomib + standard-of-care (glucocorticoids) | EXPERIMENTAL | Initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period. |
| placebo + standard-of-care (glucocorticoids) | PLACEBO_COMPARATOR | Initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period. |
| zetomipzomib + standard-of care (glucocorticoids) open-label extension period | EXPERIMENTAL | Initial 30 mg dose of zetomipzomib at the open-label extension (OLE) Week 1 visit, followed by weekly doses of 60 mg of zetomipzomib, for up to a total of 24 additional weeks of treatment. |
| Name | Type | Description |
|---|---|---|
| zetomipzomib | DRUG | Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly |
| placebo | DRUG | Subcutaneous injection of placebo |
| zetomipzomib in open-label extension | DRUG | Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly |
Key Inclusion Criteria for the Double-blind Treatment Period: * Must be aged ≥18 years. * Must have a clinical diagnosis of AIH and signs of active disease despite standard-of-care therapy for ≥3 months or disease flare after experiencing complete remission induced by standard-of-care treatment,...
Zetomipzomib is an investigational small molecule being studied for the treatment of autoimmune hepatitis, a condition where the immune system attacks the liver. It is being developed by Kezar Life Sciences, Inc. (NASDAQ: KZR) and is currently in Phase 2 clinical development.
Zetomipzomib is a small molecule that targets the immunoproteasome, a protein complex involved in antigen processing and immune regulation. By inhibiting this complex, it aims to modulate the immune response in autoimmune hepatitis. This mechanism is under investigation in clinical trials.
Zetomipzomib is being developed by Kezar Life Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol KZR. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with autoimmune hepatitis.
Zetomipzomib is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 study has been completed to assess its effects in patients with autoimmune hepatitis.
Zetomipzomib has been studied in a Phase 2 clinical trial with the identifier NCT05569759, titled 'A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA)'. This trial enrolled 24 participants in the United States and has been completed.
Yes, zetomipzomib is also known as KZR-616. The clinical trial NCT05569759 refers to the drug as both zetomipzomib and KZR-616, confirming that these names refer to the same investigational compound being developed for autoimmune hepatitis.