Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04424927 | PRV-015 in Gluten-free Diet Non-responsive Celiac Disease | PHASE2 | COMPLETED | 388 | — | — | Aug 24, 2020 | Jul 30, 2024 | Oct 20, 2025 | 38 | United States, Canada +2 |
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 |