Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FITC-Adalimumab · 1 trial · 1 indication
Local Tolerability: All intestinal mucosal adverse events observed following administration of FITC-Adalimumab. Systemic Safety and Tolerability: Number of SARs during the observation period, i.e., number of SAEs whose occurrence is due to the use of FITC-Adalimumab in this clinical trial. Number of SAEs during the observation period. Number of AEs during the observation period.
| Arm | Type | Description |
|---|---|---|
| FITC-Adalimumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| FITC-Adalimumab | DRUG | The study product FITC-Adalimumab will be topically applied via a spray catheter to the intestinal mucosa of Crohn's disease patients during endomicroscopy of the gut. One mL of the diluted study product will be applied each time to overall four selected intestinal areas at a concentration of 20 μg/mL respectively (equivalent to 20 μg of FITC-Adalimumab per area). Total amount applied will be 80 μg FITC-Adalimumab per patient. |
Inclusion Criteria: Trial subjects must meet all of the following inclusion criteria: * Male and female subjects from 18 to 70 years of age who are capable of giving informed consent without any restrictions * Endoscopically and histologically confirmed diagnosis of Crohn's disease (CD) * Manifest...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Risankizumab On-Body Injector |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
FITC-Adalimumab is an investigational small molecule being studied for use in Crohn's Disease. It is administered during confocal laser endomicroscopy of the gut to evaluate safety and tolerability. The drug is currently in Phase 1 clinical development and is not approved for any indication.
FITC-Adalimumab is being developed by Abbott Laboratories, which trades under the ticker ABT. The company is conducting clinical research on this investigational drug for Crohn's Disease.
FITC-Adalimumab is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under investigation for Crohn's Disease.
FITC-Adalimumab has one completed clinical trial, NCT01275508, titled 'Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut.' This Phase 1 study enrolled 25 participants with Crohn's Disease in Germany.
FITC-Adalimumab is a fluorescently labeled form of adalimumab, a monoclonal antibody that targets tumor necrosis factor-alpha. The FITC label allows visualization during confocal laser endomicroscopy, enabling real-time imaging of the gut. This mechanism is being studied for its safety and tolerability in Crohn's Disease.