Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as abiprubart
KPL-404 · 1 trial · 1 indication
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...
KPL-404 is being developed for the treatment of rheumatoid arthritis, specifically in patients who have had an inadequate response or intolerance to at least one biologic disease-modifying anti-rheumatic drug or a Janus kinase inhibitor. It is an investigational small molecule and has not been approved for any indication.
KPL-404 is being developed by Kiniksa Pharmaceuticals International, plc, which trades on the Nasdaq under the ticker symbol KNSA. The company is responsible for the clinical development of the drug.
KPL-404 is in Phase 2 clinical development. A Phase 2 trial in rheumatoid arthritis has been completed. The drug remains investigational and is not approved for any use.
KPL-404 has been evaluated in a Phase 2 clinical trial, NCT05198310, titled "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." This trial is completed and enrolled 145 participants.
The Phase 2 trial NCT05198310 was a randomized, double-blind, placebo-controlled study that enrolled 145 participants with rheumatoid arthritis. It included sites in the United States, Bulgaria, Czechia, Georgia, Hungary, Poland, and South Africa, and enrolled adults aged 18 years and older.