Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Darvadstrocel · 2 trials · 3 indications
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 |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants who received darvadstrocel placebo-matching expanded adipose-derived stem cells (eASCs) intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study. |
| 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 |
|---|---|---|
| Placebo | OTHER | Darvadstrocel placebo-matching eASCs intralesional injection received in previous ADMIRE-CD II study. No drug administration in this study. |
| 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: 1\. Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue). Exclusion Criteria: 1\. Has been more than 3 months since the participant completed the ADMIRE-CD II study.
Darvadstrocel is used for the treatment of complex perianal fistulas in adult participants with Crohn's disease. It is being developed for this gastrointestinal condition and is currently in Phase 3 clinical development.
Darvadstrocel is being developed by Takeda Pharmaceutical Company Limited, which is listed on the stock exchange under the ticker symbol TAK.
Darvadstrocel is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It has completed Phase 3 trials for complex perianal fistulas in Crohn's disease.
Darvadstrocel has been studied in two completed Phase 3 trials. NCT03706456 enrolled 22 participants in Japan, and NCT04075825 enrolled 150 participants across the United States, Belgium, Czechia, France, Hungary, Israel, Italy, Poland, and Spain.
Yes, Darvadstrocel is a monoclonal antibody. It is being investigated for the treatment of complex perianal fistulas in adult patients with Crohn's disease.