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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01396213 | A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease | PHASE2 | COMPLETED | 342 | — | — | Nov 7, 2011 | Aug 20, 2013 | Sep 20, 2017 | 62 | United States, Canada |
The primary efficacy endpoint was average on-treatment (Baseline to Week 12) score of theCeliac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS).
| Arm | Type | Description |
|---|---|---|
| Larazotide Acetate 0.5 mg | EXPERIMENTAL | larazotide acetate 0.5 mg capsules TID |
| Larazotide Acetate 1 mg | EXPERIMENTAL | larazotide acetate 1 mg capsules TID |
| Larazotide Acetate 2 mg | EXPERIMENTAL | larazotide acetate 2 mg capsules TID |
| Placebo | PLACEBO_COMPARATOR | placebo capsules TID |
| Name | Type | Description |
|---|---|---|
| Larazotide Acetate | DRUG | gelatin capsule |
| placebo | DRUG | gelatin capsule |
Inclusion Criteria: * Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months * measurable serology at screening * CeD GSRS score of ≥ 2.0 prior to randomization * experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nau...
| 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 |