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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04504383 | PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC) | PHASE2 | COMPLETED | 169 | — | — | Aug 5, 2020 | Feb 16, 2023 | Apr 25, 2023 | 122 | United States, Austria +11 |
Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score): * Stool frequency subscore (SFS) * Rectal bleeding subscore (RBS) * Endoscopic subscore (ESS)
| Arm | Type | Description |
|---|---|---|
| PN-943 450 mg BID | EXPERIMENTAL | Oral administration of PN-943 450 mg BID |
| PN-943 150 mg BID | EXPERIMENTAL | Oral administration of PN-943 150 mg BID |
| Placebo BID | PLACEBO_COMPARATOR | Oral administration of matching placebo |
| Name | Type | Description |
|---|---|---|
| PN-943 | DRUG | Administered by the oral route BID for the duration of the study. |
| Placebo | DRUG | Administered by the oral route BID for 12 weeks. |
Key Inclusion Criteria: 1. Male and female subjects age 18 (or the minimum country specific age of consent if \>18) to 75 years. 2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent. 3. Diagnosis of UC supported by appropriate documen...