Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Labeling Ceretec · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| PBMC Trafficking | EXPERIMENTAL | In part B, Patients undergo a blood draw (up to150 mL) and the PBMC's are separated and selected or 99mTc-HMPAO labeling. The purified and labelled cells will be re-introduced into the patient by intravenous infusion and one SPECT scan and up to 8 serial planar scintigraphy scans will initially be conducted over up to 6 hours within 1 scan session. All suitable patients showing evidence of cellular uptake in the ileo-caecal region and/or small bowel at Visit 1 will be progressed to an identical second cell labeling and scanning session at Visit 2 (48 hours later). Subjects showing no evidence of cellular uptake in the ileo-caecal region or small bowel at Visit 1 (negative scan) will be withdrawn from the study and proceed to the follow-up. |
| T Lymphocyte Trafficking | EXPERIMENTAL | In part B, Patients undergo a blood draw (up to150 mL) and the T lymphocyte cells are separated and selected or 99mTc-HMPAO labeling. The purified and labelled cells will be re-introduced into the patient by intravenous infusion and one SPECT scan and up to 8 serial planar scintigraphy scans will initially be conducted over up to 6 hours within 1 scan session. All suitable patients showing evidence of cellular uptake in the ileo-caecal region and/or small bowel at Visit 1 will be progressed to an identical second cell labeling and scanning session at Visit 2 (48 hours later). Subjects showing no evidence of cellular uptake in the ileo-caecal region or small bowel at Visit 1 (negative scan) will be withdrawn from the study and proceed to the follow-up. visit. |
| Name | Type | Description |
|---|---|---|
| Labeling Ceretec | OTHER | Technetium-99m is used to radiolabel cells of interest i.e PBMC's |
Inclusion A subject will be eligible for inclusion in this study only if all of the following criteria apply: Part A only: 1. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital signs, ECG, complete...
| 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 |
Ceretec is an investigational imaging agent being studied for use in Crohn's Disease. It is being evaluated in a Phase 1 clinical trial that uses SPECT imaging to visualize peripheral blood mononuclear cells and lymphocytes in patients with the condition. The study has been completed.
Ceretec is developed by GSK plc, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. The company is conducting clinical research on the drug for Crohn's Disease.
Ceretec is in Phase 1 clinical development for Crohn's Disease. The Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities for any use.
Ceretec has been studied in one completed Phase 1 clinical trial with the identifier NCT01051622. The trial, titled "PBMC/Lymphocyte SPECT Imaging in Crohn's Disease," enrolled 13 participants and was conducted in Belgium and the Netherlands.
Ceretec is the drug name used in the clinical trial for Crohn's Disease imaging. No alternative names for this drug have been established in the available information.