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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03102593 | A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP | PHASE2 | COMPLETED | 38 | — | — | Mar 13, 2017 | Apr 9, 2019 | Jul 25, 2023 | 30 | Austria, Belgium +8 |
Changes from Baseline in vital signs, electrocardiogram parameters (ECGs), physical examination abnormalities and clinical laboratory assessments.
| Arm | Type | Description |
|---|---|---|
| ARGX-113 Dose A + SoC | EXPERIMENTAL | Patients will be randomized in a 1:1:1 ratio to ARGX-113 (Dose A or Dose B) or placebo |
| ARGX-113 Dose B +SoC | EXPERIMENTAL | Patients will be randomized in a 1:1:1 ratio to ARGX-113 (Dose A or Dose B) or placebo |
| Placebo + SoC | PLACEBO_COMPARATOR | Patients will be randomized in a 1:1:1 ratio to ARGX-113 (Dose A or Dose B) or placebo |
| Name | Type | Description |
|---|---|---|
| ARGX-113 | DRUG | ARGX-113 (Dose A or Dose B) or matching placebo will be administered IV weekly |
| Placebo | OTHER | ARGX-113 (Dose A or Dose B) or matching placebo will be administered IV weekly |
Inclusion Criteria: 1. Male or female patients aged ≥ 18 to ≤ 85 years. 2. Must receive SoC treatment for ITP that has been stable in dose and frequency for at least 4 weeks prior to Screening. SoC may include oral corticosteroids and/or permitted oral immunosuppressants and/or TPO-R agonist. 3. Co...