Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Simtuzumab · 5 trials · 7 indications
The endpoints to be evaluated will include graded Adverse Events, laboratory abnormalities, and vital sign measurements
Progression free survival is measured as time from date of randomization to the earliest event time of death regardless of cause or first indication of disease progression.
Overall response for the study drug is defined by the reduction in bone marrow fibrosis score which is on a scale of 0-3 where 0 indicates the scattered linear reticulin with no fiber intersections representing normal marrow and 3 indicates dense increase in reticulin fibrosis with fiber intersections, often with osteosclerosis. Reduction from baseline of score indicates improvement in clinical condition.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm A | EXPERIMENTAL | Simtuzumab 75 mg for 96 weeks |
| Treatment Arm B | EXPERIMENTAL | Simtuzumab 125 mg for 96 weeks |
| Treatment Arm C | PLACEBO_COMPARATOR | Placebo for 96 weeks |
| Simtuzumab in HIV Patients | EXPERIMENTAL | HIV-infected participants will receive simtuzumab every 2 weeks for 24 weeks while continuing on standard therapy for HIV. |
| Simtuzumab in HCV Patients | EXPERIMENTAL | HCV-infected participants will receive simtuzumab every 2 weeks for 24 weeks. |
| Simtuzumab in HIV/HCV Co-Infected Patients | EXPERIMENTAL | HIV/HCV co-infected participants will receive simtuzumab every 2 weeks for 24 weeks while continuing on standard therapy for HIV. |
| Cohort 1 | EXPERIMENTAL | Participants will receive simtuzumab at a dose of 10 mg/kg by intravenous (IV) infusion every other week for a total of 3 infusions. |
| Cohort 2 | EXPERIMENTAL | Participants will receive simtuzumab IV every other week for a total of 3 infusions. The dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1 but will not exceed 20 mg/kg. |
| Simtuzumab (open-label) | EXPERIMENTAL | Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years. |
| Simtuzumab 200 mg (randomized) | EXPERIMENTAL | Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years. |
| Simtuzumab 700 mg (randomized) | EXPERIMENTAL | Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years. |
| Placebo (randomized) | PLACEBO_COMPARATOR | Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years. |
| Simtuzumab 200 mg | EXPERIMENTAL | Participants in Stage 1 of study will receive simtuzumab 200 mg for up to 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician. |
| Simtuzumab 700 mg | EXPERIMENTAL | Participants in Stage 1 of study will receive simtuzumab 700 mg for up to 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician. |
| Simtuzumab 200 mg+Ruxolitinib | EXPERIMENTAL | In Stage 2, participants on stable doses of ruxolitinib will receive simtuzumab 200 mg for at least 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician. |
| Simtuzumab 700 mg+Ruxolitinib | EXPERIMENTAL | In Stage 2, participants on stable doses of ruxolitinib will receive simtuzumab 700 mg for at least 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician. |
| Name | Type | Description |
|---|---|---|
| Simtuzumab | BIOLOGICAL | Subcutaneous injections weekly for a total of 96 injections |
| Placebo | BIOLOGICAL | Subcutaneous injections weekly for a total of 96 injections |
| Gemcitabine | DRUG | Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle |
| Placebo to match simtuzumab | DRUG | Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15) |
| Ruxolitinib | DRUG | In Stage 2, participants will be on a stable dose of ruxolitinib |
Key Inclusion Criteria: * Adult Individuals (aged 18-70) with chronic cholestatic liver disease of at least 6 months. * Liver biopsy consistent with PSC: If a liver biopsy has been performed within 3 months of the screening visit, tissue from that biopsy may be used as the screening biopsy. Slides ...
Simtuzumab is an investigational monoclonal antibody being studied for primary sclerosing cholangitis (PSC), liver fibrosis, myelofibrosis, and pancreatic cancer. It is developed by Gilead Sciences, Inc. (GILD). As of now, it is in Phase 2 clinical development and is not approved by the FDA.
Simtuzumab is a monoclonal antibody that targets lysyl oxidase-like 2 (LOXL2), an enzyme involved in fibrosis. By inhibiting LOXL2, it aims to reduce fibrotic tissue formation. This mechanism is being evaluated in conditions like liver fibrosis and PSC.
Simtuzumab is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. Gilead is conducting clinical trials to evaluate the drug's safety and efficacy in various fibrotic and oncologic indications.
Simtuzumab is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Multiple Phase 2 trials have been completed, including studies in liver fibrosis, pancreatic cancer, and primary sclerosing cholangitis.
Simtuzumab has been studied in several completed Phase 2 trials, including NCT01452308 for liver fibrosis, NCT01472198 for pancreatic cancer, NCT01672853 for primary sclerosing cholangitis, and NCT01707472 for liver fibrosis in HIV/HCV patients. All trials are completed.
Yes, Simtuzumab is also known as GS-6624. In clinical trials, it is sometimes referred to by this alternative name, such as in the study NCT01672853, which evaluates Simtuzumab (GS-6624) for primary sclerosing cholangitis.