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Monoclonal Antibodies
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 28 pre-dose, 1h post week 28 dose, 1 day post week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post week 28 dose
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests Humira® and a new version called ABP 501 in people with moderate to severe plaque psoriasis. It aims to see how switching between these medications affects their effectiveness and safety. Both drugs work by calming the immune system to reduce skin symptoms. Humira® is well established in treating moderate-to-severe chronic plaque psoriasis.
Eligible Conditions
- Plaque Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 28 pre-dose, 1h post week 28 dose, 1 day post week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post week 28 dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 28 pre-dose, 1h post week 28 dose, 1 day post week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post week 28 dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
Secondary study objectives
Number of Participants Achieving PASI 100 Response at Week 30
Number of Participants Achieving PASI 75 Response at Week 30
Number of Participants Achieving PASI 90 Response at Week 30
+5 moreSide effects data
From 2016 Phase 3 trial • 467 Patients • NCT021149318%
Upper respiratory tract infection
8%
Nasopharyngitis
7%
Hypertension
7%
Bronchitis
5%
Pharyngitis
5%
Rheumatoid arthritis
1%
Myocardial infarction
1%
Osteoarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABP 501/ABP 501
Adalimumab/ABP 501
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Switching Group (Adalimumab - ABP 501)Experimental Treatment2 Interventions
Participants will initially receive adalimumab until Week 10 during the lead-in period. Thereafter, starting from Week 12, participants will switch between ABP 501 and adalimumab Q2W with last dose of ABP 501 at Week 28.
Group II: Continued-use Group (Adalimumab)Active Control1 Intervention
Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABP 501
2013
Completed Phase 3
~1950
Adalimumab
2013
Completed Phase 4
~7950
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,466 Previous Clinical Trials
1,401,071 Total Patients Enrolled
MDStudy DirectorAmgen
1,003 Previous Clinical Trials
944,815 Total Patients Enrolled