Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rozibafusp Alfa · 2 trials · 2 indications
SRI-4 response at Week 52 is defined as a ≥ 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3), and no use of more than protocol allowed therapies.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and clinically significant changes in laboratory test results and physical exam findings. The event does not necessarily have a causal relationship with study treatment. AEs were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe or medically significant, Grade 4 = Life-threatening, and Grade 5 = Death. A serious adverse event is defined as an AE that met at least 1 of the following serious criteria: * fatal; * life threatening; * required in patient hospitalization or prolongation of existing hospitalization; * resulted in persistent or significant disability/incapacity; * congenital anomaly/birth defect; * other medically important serious event. The investigator assessed whether each AE was related to study drug.
| Arm | Type | Description |
|---|---|---|
| Rozibafusp Alfa, Dose A | EXPERIMENTAL | Investigational product solution in vial |
| Rozibafusp Alfa, Dose B | EXPERIMENTAL | Investigational product solution in vial |
| Rozibafusp Alfa, Dose C | EXPERIMENTAL | Investigational product solution in vial |
| Placebo for Rozibafusp Alfa | PLACEBO_COMPARATOR | Placebo Investigational product solution in vial |
| Rozibafusp Alfa | EXPERIMENTAL | Participants will receive rozibafusp alfa administered subcutaneously once every 2 weeks for up to 10 weeks (6 doses). Rozibafusp alfa doses will range from 70 to 420 mg. Escalation to a higher dose cohort will be contingent on a review indicating that the previous dose regimen has been found to demonstrate an acceptable safety and tolerability profile at a dose level review meeting (DLRM). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to rozibafusp alfa administered subcutaneously once every 2 weeks for up to 10 weeks (6 doses). |
| Name | Type | Description |
|---|---|---|
| Rozibafusp Alfa | DRUG | Rozibafusp Alfa will be presented in 5 mL glass vial |
| Placebo for Rozibafusp Alfa | DRUG | Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial |
| Placebo | DRUG | Administered by subcutaneous injection once every 2 weeks. |
Inclusion Criteria Screening Visit: * Subject has provided informed consent prior to initiation of any study-specific activities/procedures. * Age ≥ 18 years to ≤ 75 years at screening visit. * Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)...
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| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Upadacitinib |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Belimumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | SAR441344 |
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| Alumis Inc. | ALMS | 1 | PHASE2 | Envudeucitinib |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| Amgen Inc. | AMGN | 1 | PHASE2 | Inebilizumab, Blinatumomab |
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| Eli Lilly and Company | LLY | 1 | PHASE1 | LY4298445 |
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| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-1045 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE1 | KITE-363, Fludarabine, Cyclophosphamide |
| Artiva Biotherapeutics, Inc. | ARTV | 2 | PHASE1 | AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
Rozibafusp Alfa is an investigational drug being studied for Rheumatoid Arthritis and Systemic Lupus Erythematosus (SLE). It is developed by Amgen Inc. and is currently in clinical development, with trials completed in both indications.
Rozibafusp Alfa is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is also known as AMG 570 in clinical trials.
Rozibafusp Alfa has completed a Phase 1 trial in Rheumatoid Arthritis and a Phase 2 trial in Systemic Lupus Erythematosus (SLE). It remains an investigational drug and is not FDA approved.
Rozibafusp Alfa has been studied in two completed trials: NCT03156023, a Phase 1 multiple ascending dose study in adults with Rheumatoid Arthritis, and NCT04058028, a Phase 2 efficacy and safety study in subjects with active Systemic Lupus Erythematosus (SLE).
Yes, Rozibafusp Alfa is also known as AMG 570. Clinical trials for the drug use the name AMG 570, including NCT03156023 and NCT04058028.
The Phase 1 trial in Rheumatoid Arthritis enrolled 34 participants, while the Phase 2 trial in SLE enrolled 244 participants. Both trials were randomized, double-blind, and placebo-controlled, with a total enrollment of 244 across all studies.