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prefilled liquid etanercept · 1 trial · 1 indication
Axial SpondyloArthritis international Society (ASAS) ASAS20 was defined as an improvement of at least 20% in at least three of the following four domains: 1) patient global assessment VAS, 2) nocturnal back pain and total back pain VAS, 3) Bath AS Function Index (BASFI) VAS, and 4) inflammation (mean of intensity and duration of morning stiffness components from the an improvement at least one unit relative to baseline VAS score; no worsening in the remaining fourth domain.
| Arm | Type | Description |
|---|---|---|
| group I | EXPERIMENTAL | twice weekly 25 mg prefilled liquid etanercept |
| group II | EXPERIMENTAL | once weekly 50 mg prefilled liquid etanercept |
| group III | ACTIVE_COMPARATOR | 25 mg twice weekly lyophilized etanercept powder |
| Name | Type | Description |
|---|---|---|
| prefilled liquid etanercept(Yisaipu) | DRUG | - |
| lyophilized etanercept powder(Yisaipu) | DRUG | - |
Inclusion Criteria: * age 18-65，male or female * Sign the informed consent * Fulfill the 1966 AS New York criteria for axial spondyloarthritis(SpA) * Active disease phase of SpA, defined as BASDAI≥4 or night back pain≥4 at screening * Inadequate response to NSAID≥4 week * Application of NSAID with ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| XBiotech, Inc. | XBIT | 1 | PHASE2 | vilamakitug |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Upadacitinib |
| Novartis AG Sponsored ADR | NVS | 1 | - | Secukinumab |
| Pfizer Inc. | PFE | 1 | - | Tofacitinib |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Prefilled liquid etanercept is used for the treatment of active ankylosing spondylitis, a form of arthritis that primarily affects the spine. It is being developed as a small molecule therapy for this immunology condition. The drug is currently in Phase 3 clinical development and is being studied in a completed trial in China.
Prefilled liquid etanercept is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker symbol SBFM. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of active ankylosing spondylitis.
Prefilled liquid etanercept is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial for this drug has been completed, with a total enrollment of 640 participants.
Prefilled liquid etanercept has one completed Phase 3 clinical trial, identified as NCT04345458. This trial was titled 'Safety and Efficacy Study of Prefilled Liquid Etanercept (Yisaipu) for Active Ankylosing Spondylitis' and enrolled 640 participants in China. The study was randomized, double-blind, and active-controlled.
Yes, prefilled liquid etanercept is also known as Yisaipu. The Phase 3 clinical trial for this drug, NCT04345458, refers to it as 'Prefilled Liquid Etanercept (Yisaipu)'. This alternative name may be used in clinical and regulatory contexts.