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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07363590 | A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) | PHASE1 | RECRUITING | 21 | — | — | Feb 19, 2026 | Jul 16, 2029 | May 29, 2026 | 12 | Australia, Belgium +6 |
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
| Arm | Type | Description |
|---|---|---|
| Part 1 Prime Dose Escalation Panels | EXPERIMENTAL | Participants will receive single intravenous (IV) doses of MK-1045 at varying dose levels. |
| Part 2 Step-up Dose Escalation Panels | EXPERIMENTAL | Participants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval. |
| Part 3 Dose Expansion Panels (Optional) | EXPERIMENTAL | Participants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval. |
| Name | Type | Description |
|---|---|---|
| MK-1045 | BIOLOGICAL | IV infusion |
Inclusion Criteria: * Has a body mass index between 18 and 32 kg/m\^2, inclusive * Systemic lupus erythematosus (SLE): Has a diagnosis of SLE for at least 6 months and met the European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) 2019 classification crit...