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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02609789 | A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus | PHASE1 | COMPLETED | 72 | — | — | Dec 1, 2015 | Sep 1, 2018 | Feb 3, 2025 | 16 | United States, Belgium +5 |
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
| Arm | Type | Description |
|---|---|---|
| Part A: Dose 1 | EXPERIMENTAL | Drug JNJ-55920839 or Placebo administered IV infusion Dose 1. |
| Part A: Dose 2 | EXPERIMENTAL | Drug JNJ-55920839 or Placebo administered IV infusion Dose 2. |
| Part A: Dose 3 | EXPERIMENTAL | Drug JNJ-55920839 or Placebo administered IV infusion Dose 3. |
| Part A: Dose 4 | EXPERIMENTAL | Drug JNJ-55920839 or Placebo administered IV infusion Dose 4. |
| Part A: Dose 5 | EXPERIMENTAL | Drug JNJ-55920839 or Placebo administered IV infusion Dose 5. |
| Part A: Dose 6 | EXPERIMENTAL | Drug JNJ-55920839 or Placebo subcutaneous injection Dose 6. |
| Part B | EXPERIMENTAL | Participants will receive 6 doses of JNJ-55920839 or placebo (every 2 weeks) as an IV infusion. |
| Name | Type | Description |
|---|---|---|
| JNJ-55920839 | DRUG | JNJ-55920839 will be administered as either IV infusion or subcutaneous injection. |
| Placebo | DRUG | 0.9 percent (%) normal saline. |
Inclusion Criteria: Part A (Healthy Participants) * Participant must be willing/able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions specified in this protocol * Participant must have a body weight in the range of 50 to 90 kilogram (kg), inclusive, and ...