Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GP2017 Adalimumab · 1 trial · 1 indication
The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.
| Arm | Type | Description |
|---|---|---|
| GP2017 Adalimumab | EXPERIMENTAL | Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51. |
| Humira ® Adalimumab | ACTIVE_COMPARATOR | Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51. |
| Name | Type | Description |
|---|---|---|
| GP2017 Adalimumab | DRUG | - |
| Humira ® Adalimumab | DRUG | - |
Inclusion Criteria: * Men or women at least 18 years of age at time of screening * Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization * Moderate to severe psoriasis as defined at baseline by: * PASI score of 12 or greater * Investigator´s Global Assessment score...
GP2017 Adalimumab is an investigational biosimilar being developed for the treatment of plaque type psoriasis, a chronic skin condition characterized by red, scaly patches. It is being studied in patients with this condition to demonstrate equivalent efficacy and compare safety against the reference product Humira.
GP2017 Adalimumab is a biosimilar to adalimumab, which targets tumor necrosis factor alpha (TNF-alpha), a cytokine involved in systemic inflammation. By binding to TNF-alpha, it is designed to block its activity and reduce the inflammatory response associated with plaque type psoriasis.
GP2017 Adalimumab is being developed by Novartis AG, a global healthcare company based in Switzerland. Novartis is listed on the stock exchange under the ticker symbol NVS.
GP2017 Adalimumab is in Phase 3 clinical development. It has completed a Phase 3 trial, but it remains investigational and has not been approved by regulatory authorities. The drug is still undergoing clinical evaluation to assess its efficacy and safety compared to the reference product.
GP2017 Adalimumab has been studied in one completed Phase 3 clinical trial with the identifier NCT02016105. This trial, titled 'Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira', enrolled 465 participants with plaque type psoriasis across the United States, Bulgaria, France, and Slovakia.
GP2017 Adalimumab is a biosimilar candidate intended to be similar to Humira (adalimumab), but it is not the same product. It is designed to demonstrate equivalent efficacy and comparable safety to Humira in treating plaque type psoriasis. The Phase 3 trial compared GP2017 directly against Humira.