Phase 3
N=425
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT05073315 ↗Enrolled (actual)
425
Serious AEs
1.5%
Results posted
Feb 2024
Primary outcome: Primary: Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) — 1458.03; 1472.68 hr*μg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adalimumab (Drug); ABP 501 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) |
1458.03; 1472.68 | — |
| PRIMARY Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) |
4.91; 5.01 | — |
| SECONDARY Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) |
72.30; 72.35 | — |
| SECONDARY Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) |
4528.7316; 4072.5556; 4046.3069; 3682.0016; 4113.0839; 4332.1272 | — |
| SECONDARY PASI Percent Improvement From Baseline (Day 1) to Week 30 |
88.56; 91.01 | — |
| SECONDARY Number of Participants Achieving PASI 75 Response at Week 30 |
131; 134 | — |
| SECONDARY Number of Participants Achieving PASI 90 Response at Week 30 |
92; 108 | — |
| SECONDARY Number of Participants Achieving PASI 100 Response at Week 30 |
52; 61 | — |
| SECONDARY Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) |
97; 106; 3; 4 | — |
| SECONDARY Number of Participants Experiencing Events of Interest (EOI) |
13; 17 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization |
186; 194; 25; 18; 16; 10 | — |
Summary
Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.
Eligibility Criteria
Inclusion Criteria
- Participants has moderate to severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months and has stable disease for at least 2 months
- Participants has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA) and static Physician's Global Assessment (sPGA) ≥ 3 at screening and at baseline
- Participant has no known history of latent or active tuberculosis
Exclusion Criteria
- Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication induced psoriasis, or other skin conditions at the time of screening (eg, eczema) that would interfere with evaluations of the effect of investigational product of psoriasis
- Participant has an active infection or history of infections
- Participant has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment
- Participant has received nonbiologic systemic psoriasis therapy within 4 weeks prior to enrollment
- Participant has received ultraviolet (UV) A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks prior to enrollment
- Participant has received topical psoriasis treatment within 2 weeks prior to enrollment
Data sourced from ClinicalTrials.gov (NCT05073315). 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.