Phase 3
Completed N=350
Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT01970488 ↗Enrolled (actual)
350
Serious AEs
3.5%
Results posted
Dec 2016
Primary outcomePrimary: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 — 80.91; 83.06 percent change
◆ Published Evidence
Established
82citations · ~9 / year
Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis.
Summary
The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.
Linked Publications
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Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 |
80.91; 83.06 | — |
| SECONDARY Percentage of Participants With a PASI 75 Response at Week 16 |
74.4; 82.7 | — |
| SECONDARY Percentage of Participants With a PASI 75 Response at Week 32 |
82.5; 84.7; 84.5 | — |
| SECONDARY Percentage of Participants With a PASI 75 Response at Week 50 |
85.1; 87.1; 81.2 | — |
| SECONDARY Percent Improvement From Baseline in PASI at Week 32 |
87.62; 88.16; 86.98 | — |
| SECONDARY Percent Improvement From Baseline in PASI at Week 50 |
87.16; 88.11; 85.82 | — |
| SECONDARY Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16 |
58.7; 65.3 | — |
| SECONDARY Percentage of Participants With a sPGA Response at Week 32 |
66.4; 72.2; 70.4 | — |
| SECONDARY Percentage of Participants With a sPGA Response at Week 50 |
68.7; 74.3; 69.6 | — |
| SECONDARY Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16 |
-18.0; -22.1 | — |
| SECONDARY Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32 |
-20.6; -25.3; -23.8 | — |
| SECONDARY Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50 |
-20.7; -25.5; -25.1 | — |
| SECONDARY Number of Participants With Adverse Events |
117; 110; 108; 52; 54; 8 | — |
| SECONDARY Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab |
55.2; 63.6; 68.4; 74.7; 72.7; 9.8 | — |
Eligibility Criteria
Inclusion criteria
- Men or women ≥ 18 and ≤ 75 years of age at time of screening
- Stable moderate to severe plaque psoriasis for at least 6 months before baseline
- Moderate to severe psoriasis defined at screening and baseline by:
Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater, and static physician's global assessment score of 3 or greater
- No known history of active tuberculosis
- Subject is a candidate for systemic therapy or phototherapy procedures
- Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy
Exclusion Criteria
- Forms of psoriasis or other skin conditions at the time of the screening visit (eg, eczema)
- Ongoing use of prohibited treatments
- Prior use of 2 or more biologics for treatment of psoriasis
- Previous receipt of adalimumab or a biosimilar of adalimumab
Other Inclusion/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01970488) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.