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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03093402 | JBT-101 in Systemic Lupus Erythematosus (SLE) | PHASE2 | COMPLETED | 109 | — | — | Dec 21, 2017 | Jul 28, 2021 | May 6, 2026 | 16 | United States |
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants will be asked to report their maximum daily pain using the NRS-Pain. Participants will call into an interactive voice response e diary system (IVRS) and record the number that best reflects their maximum amount of pain experienced in the last 24 hours. Participants will be asked to call at the same time each day, preferably before bedtime. Longitudinal trends over the course of the treatment period will be modeled and used to estimate difference between means at baseline and Day 84 for each treatment group.
| Arm | Type | Description |
|---|---|---|
| JBT-101: 5 mg Twice Daily | EXPERIMENTAL | Eligible subjects will receive assigned study treatment of JBT-101 5 mg administered twice daily. |
| JBT-101: 20 mg & Placebo | EXPERIMENTAL | Eligible subjects will receive assigned study treatment of JBT-101 20 mg (A.M. Study Product) and 20 mg Placebo (P.M. Study Product). |
| JBT-101: 20 mg Twice Daily | EXPERIMENTAL | Eligible subjects will receive assigned study treatment of JBT-101 20 mg (A.M. Study Product) and JBT-101 20 mg (P.M. Study Product). |
| Placebo + Placebo | PLACEBO_COMPARATOR | Eligible subjects will receive assigned study treatment of Placebo (A.M.) and Placebo (P.M.) for (JBT-101). |
| Name | Type | Description |
|---|---|---|
| JBT-101 | DRUG | Participants will self-administer JBT-101 by mouth (orally), at prescribed dose and frequency per protocol, Days 1-84. Administration of dose(s) should be at least 8 hours apart. |
| Placebo | DRUG | Participants will self-administer JBT-101 placebo by mouth (orally), at prescribed dose and frequency per protocol, Days 1-84. Administration of dose(s) should be at least 8 hours apart. |
Inclusion Criteria: * Fulfills the updated American College of Rheumatology (ACR) 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus; * At least 3 months of treatment with an anti-malarial drug such as hydroxychloroquine or a history of intolerance, contraindication, or un...