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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06576271 | A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants | PHASE1 | RECRUITING | 142 | — | — | Sep 2, 2024 | Jan 11, 2028 | Apr 29, 2026 | 27 | United States, Argentina +4 |
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. A suicidal ideation score will be calculated based on the maximum suicidal ideation category ranging from 1 to 5. Higher score indicates more suicidal ideation. A clinically important change in the C-SSRS is defined as a total score \>0.
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. A suicidal ideation score will be calculated based on the maximum suicidal ideation category ranging from 1 to 5. Higher score indicates more suicidal ideation. A clinically important change in the C-SSRS is defined as a total score \>0.
| Arm | Type | Description |
|---|---|---|
| Part A: Healthy participants receiving GSK4527363 | EXPERIMENTAL | - |
| Part A: Healthy participants receiving placebo matching GSK4527363 | PLACEBO_COMPARATOR | - |
| Part A: Healthy participants receiving belimumab | EXPERIMENTAL | - |
| Part B: Participants with SLE receiving GSK4527363 | EXPERIMENTAL | - |
| Part B: Participants with SLE receiving belimumab | EXPERIMENTAL | - |
| Part C: Healthy Japanese participants receiving GSK4527363 | EXPERIMENTAL | - |
| Part C: Healthy Japanese participants receiving placebo matching GSK4527363 | PLACEBO_COMPARATOR | - |
| Part C: Healthy Chinese participants receiving GSK4527363 | EXPERIMENTAL | - |
| Part C: Healthy Chinese participants receiving placebo matching GSK4527363 | PLACEBO_COMPARATOR | - |
| Part D: Participants with CTD-ILD receiving GSK4527363 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GSK4527363 | DRUG | GSK4527363 will be administered to participants. |
| Placebo matching GSK4527363 | DRUG | Placebo matching GSK4527363 will be administered to participants. |
| Belimumab | DRUG | Belimumab will be administered to participants. |
Inclusion criteria: For Part A and Part C (Healthy Participants): * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, labo...