Approval Probability
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Adjusted LOA
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PRV-015 · 1 trial · 1 indication
The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Abdominal Symptoms domain included abdominal cramping, abdominal pain, bloating and gas. Total score for abdominal symptoms domain range from 0 to 40. Higher scores indicated worse outcome. Baseline abdominal symptoms domain score was defined as the average of the daily scores for the last week of the placebo run-in period.
| Arm | Type | Description |
|---|---|---|
| PRV-015 Low Dose | EXPERIMENTAL | PRV-015 Low Dose, sterile solution for subcutaneous administration |
| PRV-015 Medium Dose | EXPERIMENTAL | PRV-015 Medium Dose, sterile solution for subcutaneous administration |
| PRV-015 High Dose | EXPERIMENTAL | PRV-015 High Dose, sterile solution for subcutaneous administration |
| Placebo | PLACEBO_COMPARATOR | Placebo, sterile solution for subcutaneous administration |
| Name | Type | Description |
|---|---|---|
| PRV-015 | BIOLOGICAL | Fully human monoclonal antibody against interleukin 15 (IL-15) |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * A diagnosis of celiac disease by intestinal biopsy * Following a GFD for at least 12 consecutive months * Must have detectable (above the lower limit of detection) serum celiac-related antibodies * Must have human leukocyte antigen DQ (HLA-DQ) typing consistent with celiac dis...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | Amlitelimab |
| Forte Biosciences Inc. | FBRX | 1 | PHASE2 | FB102 |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 1 | PHASE2 | TEV-53408 |
| Barinthus Biotherapeutics plc Sponsored ADR | BRNS | 1 | EARLY_PHASE1 | VTP-1000 |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
PRV-015 is an investigational monoclonal antibody being studied for the treatment of celiac disease, specifically in patients who do not respond adequately to a gluten-free diet. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
PRV-015 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. The drug is currently in Phase 2 clinical trials for celiac disease.
PRV-015 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. A Phase 2 trial has been completed to evaluate its safety and efficacy in patients with celiac disease.
PRV-015 has been studied in a Phase 2 clinical trial with the identifier NCT04424927, titled "PRV-015 in Gluten-free Diet Non-responsive Celiac Disease." This completed trial enrolled 388 participants across the United States, Canada, Netherlands, and Spain.
PRV-015 is a monoclonal antibody designed to target a specific molecular pathway involved in celiac disease. By binding to its target, it aims to modulate the immune response that causes intestinal damage in patients who do not respond to a gluten-free diet.
PRV-015 is a distinct investigational drug and is not known to be the same as any other approved medication. It is a monoclonal antibody being developed specifically for celiac disease and is currently in Phase 2 clinical trials.