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Also known as AMG 611, VIB 4920, MEDI4920
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 | Ianalumab |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE3 | Deucravacitinib |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| argenx SE Sponsored ADR | ARGX | 2 | PHASE3 | Efgartigimod PH20 SC |
| Amgen Inc. | AMGN | 2 | PHASE3 | Dazodalibep |
| Vor Biopharma, Inc. | VOR | 1 | PHASE3 | Telitacicept |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| Artiva Biotherapeutics, Inc. | ARTV | 1 | PHASE2 | AB-101 |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
| Lakefront Biotherapeutics Sponsored ADR | LKFT | 1 | PHASE1 | OM336 |
Dazodalibep is being developed for the treatment of Sjogren's Syndrome, an autoimmune condition. It is an investigational therapy and is not yet approved for commercial use. Amgen Inc. is evaluating it in Phase 3 clinical trials in patients with moderate-to-severe symptom state and moderate-to-severe systemic disease activity.
Dazodalibep targets CD40LG, also known as CD40 ligand. It acts as an antagonist, blocking this molecular target. CD40LG is involved in immune cell signaling, and antagonizing it is intended to modulate the immune response in Sjogren's Syndrome. The target class is antagonist.
Amgen Inc. (ticker: AMGN) is the developer of Dazodalibep. The company is running the clinical development program for this asset in Sjogren's Syndrome.
Dazodalibep is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The program includes three registered trials, with two currently active and one completed, totaling 1,929 enrolled participants across the studies.
Dazodalibep is being studied in three Phase 3 trials. NCT06747949 is a recruiting long-term extension study in Sjogren's Syndrome. NCT06245408 is an active, not recruiting safety and efficacy study in patients with moderate-to-severe symptom state. NCT06104124 is a completed study in patients with moderate-to-severe systemic disease activity.
Yes, Dazodalibep is a small molecule therapeutic. It is being developed as an antagonist of CD40LG for Sjogren's Syndrome. The clinical program includes randomized, double-blind, placebo-controlled Phase 3 trials.