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Dazodalibep · 3 trials · 3 indications
Includes treatment emergent serious adverse events (TESAEs) and adverse events of special interest (AESIs).
| Arm | Type | Description |
|---|---|---|
| Dazodalibep | EXPERIMENTAL | Participants who completed the 48-week dazodalibep or placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive assigned dose Dose A of dazodalibep for an additional 132 weeks. |
| Dazodalibep Dose 1 | EXPERIMENTAL | Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion. |
| Dazodalibep Dose 2 | EXPERIMENTAL | Participants will be administered dose 2 of dazodalibep by IV infusion. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered placebo by IV infusion. |
| Name | Type | Description |
|---|---|---|
| Dazodalibep | DRUG | Dazodalibep will be given intravenously (IV). |
| Placebo | DRUG | IV infusion |
Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: * Participant has provided informed consent before initiation of any study specific activities/procedures. * Must have been eligible to receive and have received IP (dazodalibep or p...
| 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 |
Dazodalibep is an investigational small molecule being developed for Sjögren's Syndrome (SS), an autoimmune condition. It is studied in adults aged 18 years and older with moderate-to-severe systemic disease activity or moderate-to-severe symptom state. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Dazodalibep is being developed by Amgen Inc., a biopharmaceutical company listed on NASDAQ under the ticker symbol AMGN. The company is conducting Phase 3 clinical trials to evaluate the efficacy and safety of Dazodalibep in participants with Sjögren's Syndrome.
Dazodalibep is in Phase 3 clinical development. It is being evaluated in multiple Phase 3 trials for Sjögren's Syndrome, including studies for moderate-to-severe systemic disease activity and moderate-to-severe symptom state. As an investigational drug, it has not yet received regulatory approval.
Dazodalibep is being studied in three Phase 3 clinical trials. NCT06104124 evaluates its efficacy and safety in Sjögren's Syndrome with moderate-to-severe systemic disease activity. NCT06245408 assesses it in moderate-to-severe symptom state. NCT06747949 is a long-term extension study. All trials are active, with the extension study currently recruiting.
Yes, Dazodalibep is being studied in randomized, double-blind, placebo-controlled Phase 3 trials. This design is used to compare the drug's effects against a placebo in participants with Sjögren's Syndrome, helping to determine its efficacy and safety profile in a controlled setting.
The Dazodalibep Phase 3 program includes trials with a total planned enrollment of up to 844 participants. The two efficacy trials have enrollments of 651 and 434 participants respectively, while the long-term extension study has a target enrollment of 844 participants across multiple countries.