Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04541589 | Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome | PHASE2 | COMPLETED | 206 | — | — | Jan 5, 2021 | Aug 19, 2024 | Oct 16, 2025 | 62 | United States, Argentina +21 |
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 | 4 | PHASE3 | VAY736, Ianalumab, VAY736 PFS, VAY736 AI |
| Amgen Inc. | AMGN | 3 | PHASE3 | Dazodalibep |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE3 | Deucravacitinib |
| argenx SE Sponsored ADR | ARGX | 1 | PHASE3 | Efgartigimod PH20 |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| 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 |