Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DLX105 · 1 trial · 1 indication
Investigator and Patient will assess the local tolerability of DLX105 for each treated fistula using a 10-cm visual analogue scale (VAS) at each study visit. Changes from Baseline will be reported descriptively.
Reduction of number of draining fistulas of 50% from baseline observed at Visit 10 and confirmed at End of Study Visit.
| Arm | Type | Description |
|---|---|---|
| DLX105 | ACTIVE_COMPARATOR | DLX105 local injection into the identified fistula(s) |
| Placebo Injection | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DLX105 | DRUG | 10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks. |
| Placebo | DRUG | Placebo injections are administered over the treatment period of 4 weeks. |
Inclusion Criteria: * Diagnosis of Crohn' Disease * Single or multiple enterocutaneous abdominal and/or perianal and/or rectovaginal fistulas of at least 3 months'duration. * TNF-blocker naive patients or patients who are primary or secondary anti-TNF non-responders Exclusion Criteria: * CDAI gre...
DLX105 is an investigational small molecule being developed for fistulizing Crohn's Disease, a form of Crohn's disease characterized by abnormal connections, or fistulas, between the intestine and other organs. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
DLX105 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical research to evaluate the safety and efficacy of DLX105 in patients with fistulizing Crohn's Disease.
DLX105 is in Phase 2 clinical development. It has completed a Phase 2 trial, but it remains investigational and has not received regulatory approval. The drug is still being studied to determine its safety and effectiveness for treating fistulizing Crohn's Disease.
DLX105 has been studied in one clinical trial, identified as NCT01624376. This was a randomized, double-blind, placebo-controlled Phase 2 study in patients with fistulizing Crohn's Disease. The trial enrolled 18 participants and was conducted in Switzerland, with a minimum age of 18 years.
No alternative names for DLX105 have been reported. It is a distinct investigational compound being developed by cbdMD, Inc. for the treatment of fistulizing Crohn's Disease. As of now, it is not known to be identical to any other marketed or investigational drug.