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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01970488 | Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis | PHASE3 | COMPLETED | 350 | — | — | Oct 18, 2013 | Mar 18, 2015 | Apr 3, 2019 | 3 | Australia, Canada +1 |
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
| Arm | Type | Description |
|---|---|---|
| ABP 501 | EXPERIMENTAL | Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. Participants with a PASI 50 response at week 16 continued to receive 40 mg APB 501 until week 48. |
| Adalimumab | ACTIVE_COMPARATOR | Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to ABP 501 until week 48. |
| Name | Type | Description |
|---|---|---|
| Adalimumab | BIOLOGICAL | Administered by subcutaneous injection |
| ABP 501 | BIOLOGICAL | Administered by subcutaneous injection |
Inclusion criteria: 1. Men or women ≥ 18 and ≤ 75 years of age at time of screening 2. Stable moderate to severe plaque psoriasis for at least 6 months before baseline 3. Moderate to severe psoriasis defined at screening and baseline by: Body surface area (BSA) affected by plaque psoriasis of 1...