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Also known as Cx601
Darvadstrocel · 5 trials · 4 indications
Combined Remission of perianal fistulising Crohn's disease defined as the clinical assessment of closure of all treated external openings (EO) that were draining at baseline despite gentle finger compression at week 24, and absence of collections \> 2 cm of the treated perianal fistulas confirmed by centrally blinded MRI assessment by week 24.
Combined remission was defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression and absence of collection(s) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central magnetic resonance imaging (MRI) assessment. Percentages are rounded off to whole number at the nearest decimal.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
TEAE is defined as: any adverse event emerging/manifesting at or after the initiation of treatment with a study intervention/medicinal product or any existing event that worsens in either intensity/frequency following exposure to the study intervention/medicinal product. Serious adverse event (SAE) is an untoward medical occurrence, significant hazard, contraindication, side effect/precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that require close monitoring and prompt reporting to the sponsor. Protocol pre-specified AESIs included immunogenicity/allo-immunoreactions, tumorigenicity, ectopic tissue formation and fistula/abscess. In addition, ad hoc AESIs of anaphylactic reaction, hypersensitivity, and malignancy.
Combined remission of perianal fistulising CD is defined as the clinically confirmed closure of all treated external openings that were draining at Screening despite gentle finger compression, and absence of collections \>2 cm in the treated fistulas, confirmed by central magnetic resonance imaging (MRI) assessment at Week 24 visit. In case of missing values, last observation carried forward (LOCF) method was applied. Percentages are rounded off to the nearest decimal point.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Cx601 is a cell suspension in aseptic buffered solution containing human expanded adipose-derived stem cells (eASCs) of allogeneic origin in disposable vials with no preservative agents. The cells will be given at a dose of 120 million cells (5 million cells / mL) for intralesional injection. |
| Placebo-control group | PLACEBO_COMPARATOR | Placebo (saline solution) will be given also for intralesional injection at the same quantity (volume, 24 mL) and following the same schedule. |
| Placebo | PLACEBO_COMPARATOR | Placebo (saline) 24 milliliters (mL) was administered once by local injection. |
| Cx601 | EXPERIMENTAL | Cx601 expanded adipose-derived stem cells (eASCs) 120 million cells (5 million cells per mL) was administered once by local injection. |
| Darvadstrocel | EXPERIMENTAL | Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study. |
| Darvadstrocel 24 mL | EXPERIMENTAL | Darvadstrocel (Cx601) 24 mL suspension of 120 million cells of expanded allogeneic adipose-derived stem cells (eASC) as an intralesional injection, once on Day 1. |
| Name | Type | Description |
|---|---|---|
| Cx601 | OTHER | 120 million cells administered by intralesional injection. |
| Saline solution | OTHER | 24 mL saline solution by intralesional injection |
| Placebo | OTHER | Cx601 placebo-matching eASCs intralesional injection. |
| Darvadstrocel | BIOLOGICAL | Allogenic expanded adipose-derived stem cells (eASCs) 5 million cells/ml - suspension for injection darvadstrocel received in previous ADMIRE-CD II study. No drug administration in this study. |
Inclusion Criteria: The reference population will consist of patients with perianal fistulising Crohn´s disease refractory to at least one of the following treatments: antibiotics, immunosuppressants or anti-tumor necrosis factor (TNF). Naïve patients are excluded, and those patients refractory to ...
Darvadstrocel is a cell therapy developed by Takeda Pharmaceutical Company Limited for complex perianal fistulas in adult participants with Crohn's disease. It is being studied in Phase 3 clinical development. Complex perianal fistulas are abnormal connections between the anal canal and the skin near the anus that can occur in people with Crohn's disease.
Darvadstrocel is being developed for the treatment of complex perianal fistulas in adult participants with Crohn's disease. This gastrointestinal condition involves fistulas that connect the anal canal to surrounding tissue. The therapy is under investigation in Phase 3 trials and is not yet approved.
Darvadstrocel is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical development program for this cell therapy in complex perianal fistulas associated with Crohn's disease.
Darvadstrocel is in Phase 3 clinical development. It is an investigational cell therapy and has not been approved by the FDA. The Phase 3 program includes completed studies evaluating the treatment in adults with complex perianal fistulas and Crohn's disease.
Darvadstrocel has been studied in two completed Phase 3 trials. NCT04075825 is a long-term follow-up study in complex perianal fistula with 150 participants across the United States, Belgium, Czechia, France, Hungary, Israel, Italy, Poland, and Spain. NCT03706456 is a Phase 3 study in Japan with 22 participants.
Darvadstrocel is a cell therapy, which means it uses living cells as the active treatment rather than a conventional small molecule or protein drug. It is being developed for complex perianal fistulas in adults with Crohn's disease, a gastrointestinal condition, and is currently in Phase 3 clinical development.