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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04713072 | A Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis | PHASE2 | COMPLETED | 129 | — | — | Aug 4, 2020 | Jan 27, 2022 | Feb 9, 2024 | 32 | Austria, Belgium +5 |
ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo
ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo
| Arm | Type | Description |
|---|---|---|
| ABY-035 40 mg | EXPERIMENTAL | 40 mg ABY-035 SC |
| ABY-035 80 mg | EXPERIMENTAL | 80 mg ABY-035 SC |
| Placebo | PLACEBO_COMPARATOR | Placebo, switching to 80 mg ABY-035 after 16 weeks |
| Name | Type | Description |
|---|---|---|
| ABY-035 | BIOLOGICAL | ABY-035 solution for injection |
| Placebo | BIOLOGICAL | Placebo to ABY-035 solution for injection |
Inclusion criteria: * Patient who has given his / her signed declaration of consent and data protection declaration * At least 18 years and less than 75 years of age at Screening visit * Psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of ...