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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05198310 | Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor | PHASE2 | COMPLETED | 145 | — | — | Dec 14, 2021 | May 6, 2024 | Jul 22, 2025 | 42 | United States, Bulgaria +5 |
Adverse event (AE): any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. Serious AE (SAE): AE that: results in death; is immediately life-threatening; requires in-patient hospitalization/prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital abnormality/birth defect; is an important medical event. TEAEs: AEs not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug during treatment period. AE severity: mild (Grade \[Gr\] 1); moderate (Gr 2); severe (Gr 3); potentially life threatening (Gr 4); death (Gr 5). AEs of special interest: thrombosis, serious infection, serious and non-serious bacterial infections, eye disorders, and anaphylaxis/hypersensitivity reactions.
DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). DAS28-CRP is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale \[VAS\] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score \< 2.6, low disease activity = score \< 3.2). A negative value in change from BL indicates an improvement.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 KPL-404 2 mg/kg Every 2 Weeks (q2wk) | EXPERIMENTAL | KPL-404 2 mg/kg subcutaneous (SC) q2wk for 12 weeks |
| Cohort 1 Placebo | PLACEBO_COMPARATOR | Placebo SC q2wk for 12 weeks |
| Cohort 2 KPL-404 5 mg/kg q2wk | EXPERIMENTAL | KPL-404 5 mg/kg SC q2wk for 12 weeks |
| Cohort 2 Placebo | PLACEBO_COMPARATOR | Placebo SC q2wk for 12 weeks |
| Cohort 3 KPL-404 5 mg/kg qwk | EXPERIMENTAL | KPL-404 5mg/kg SC once weekly (qwk) for 12 weeks |
| Cohort 3 KPL-404 5 mg/kg q2wk | EXPERIMENTAL | KPL-404 5mg/kg SC q2wk with alternating weekly administrations of KPL-404 or placebo SC for 12 weeks |
| Cohort 3 Placebo | PLACEBO_COMPARATOR | Placebo SC qwk for 12 weeks |
| Cohort 4 KPL-404 400 mg q4wk | EXPERIMENTAL | KPL-404 SC every 4 weeks (q4wk) for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8. |
| Cohort 4 Placebo | PLACEBO_COMPARATOR | Placebo SC q4wk for 12 weeks |
| Name | Type | Description |
|---|---|---|
| KPL-404 | DRUG | Humanized monoclonal antibody |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: * Body weight ≥ 40 to ≤ 140 kg for all cohorts. * Diagnosis of RA for ≥ 3 months fulfilling the 2010 American College of Rheumatology (ACR)/European Union League Against Rheumatism (EULAR) classification criteria for RA and that is categorized as ACR RA functional Class 1-3. * T...