Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Iscalimab · 1 trial · 1 indication
An AE was defined as any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant. TEAE included all AEs up to the last dose date plus 14 weeks or the end of the entire study (including the safety follow-up period), whichever occurred earlier. A patient with multiple severity ratings for an AE was only counted under the maximum rating. Additionally, a patient with multiple occurrences of an event was counted only once. The severity of AEs was assessed using the Common Terminology Criteria for Adverse Events, with the following grading system: Mild: usually transient in nature and generally not interfering with normal activities; Moderate: sufficiently discomforting to interfere with normal activities; Severe: prevented normal activities. A serious adverse event (SAE) was defined as any AE that required medical intervention, hospitalization, or results in death, disability, or a birth defect.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Iscalimab 600 mg | EXPERIMENTAL | Participants received 600 mg (2 injections of 300 mg/2 mL) of iscalimab subcutaneously weekly for the initial 3 weeks as loading doses, followed by a bi-weekly maintenance regimen at 600 mg (2 injections of 300 mg/2 mL). |
| Arm 2 - Iscalimab 300 mg | EXPERIMENTAL | Participants received one dose of 600 mg (2 injections of 300 mg/2 mL) of iscalimab subcutaneously on the first day of the extension study; then 300 mg weekly (1 injection of 300 mg/2 mL of iscalimab and 1 injection of 2 mL of placebo) for the next 2 weeks as loading doses. This was followed by a bi-weekly maintenance regimen of 300 mg (1 injection of 300 mg/2 mL of iscalimab and 1 injection of 2 mL of placebo). After the final database lock of the core study, participants underwent unblinding, leading to the discontinuation of placebo injections. |
| Name | Type | Description |
|---|---|---|
| Iscalimab | DRUG | Iscalimab 600 mg or 300 mg was administered subcutaneously weekly for the first 3 weeks. Subsequently, iscalimab was administered subcutaneously bi-weekly (every other week or Q2W). |
| Placebo | OTHER | Placebo (1 injection of 2 ml) administered to participants in the iscalimab 300 mg arm to maintain blinding until the final database lock of the core study |
Inclusion Criteria: 1. Participants had to have participated in the TWINSS core study, CCFZ533B2201 (NCT03905525), and had to have completed the entire treatment period up to Week 48 and the follow-up period up to Week 60. 2. Signed informed consent had to be obtained prior to participation in the ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | VAY736 |
| Amgen Inc. | AMGN | 3 | PHASE3 | Dazodalibep |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE3 | Deucravacitinib |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| argenx SE Sponsored ADR | ARGX | 1 | PHASE3 | Efgartigimod PH20 |
| Vor Biopharma, Inc. | VOR | 1 | PHASE3 | Telitacicept |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| Artiva Biotherapeutics, Inc. | ARTV | 1 | PHASE2 | Allogeneic NK Cells |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
| Precision BioSciences, Inc. | DTIL | 1 | PHASE1 | CD19 targeted CAR-T cells |
Iscalimab is an investigational small molecule being studied for the treatment of Sjogren's Syndrome, an autoimmune condition affecting moisture-producing glands. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Iscalimab is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Sjogren's Syndrome.
Iscalimab is in Phase 2 clinical development for Sjogren's Syndrome. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to assess its safety and effectiveness.
Iscalimab has one completed Phase 2 clinical trial registered under NCT04541589, titled 'Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome'. The trial enrolled 206 participants across multiple countries and was double-blind and controlled.
Yes, Iscalimab is also known as CFZ533. The clinical trial NCT04541589 refers to the drug as CFZ533, and both names are used interchangeably in research and development contexts.