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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02713243 | To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea. | PHASE2 | COMPLETED | 20 | — | — | Jan 16, 2016 | Jan 25, 2018 | Jan 5, 2021 | 4 | United States, United Kingdom |
Number of patients reported with adverse events , serious adverse events and death.
Stool frequency at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined
Stool Form at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined Clinical Symptoms will be measured as change from baseline in stool types per Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify feces on a scale from 1 to 7 according to increasing wateriness.
| Arm | Type | Description |
|---|---|---|
| LJN452 followed by placebo | EXPERIMENTAL | Randomized patients in this arm will receive single oral dose of LJN452 daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of placebo daily for 14 days. |
| Placebo followed by LJN452 | EXPERIMENTAL | Randomized patients in this arm will receive single oral dose of placebo daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of LJN452 daily for 14 days. |
| Name | Type | Description |
|---|---|---|
| LJN452 | DRUG | Capsules containing LJN452 |
| Placebo to LJN452 | DRUG | Capsules containing placebo to LJN452 |
Key Inclusion Criteria: * A history of diarrheal symptoms for at least 3 months prior to dosing - Average stool frequency of at least 2 per day when off therapy AND Average stool form of \>5 on Bristol Stool Chart. * Previous laboratory or radiological confirmation of bile acid malabsorption with e...