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Monoclonal Antibodies

ABP 501 for 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

Study Summary

This trial is testing a new high concentration formulation of Humira compared to continued use of Humira in people with moderate to severe plaque psoriasis.

Eligible Conditions
  • Plaque Psoriasis

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
+6 more

Side effects data

From 2016 Phase 3 trial • 467 Patients • NCT02114931
11%
Nasopharyngitis
9%
Upper respiratory tract infection
7%
Rheumatoid arthritis
5%
Bronchitis
3%
Pharyngitis
3%
Hypertension
1%
Osteoarthritis
1%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adalimumab/ABP 501
ABP 501/ABP 501

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
~6480

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,371 Previous Clinical Trials
1,377,681 Total Patients Enrolled
MDStudy DirectorAmgen
914 Previous Clinical Trials
924,154 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the FDA's stance on ABP 501?

"There is existing clinical evidence backing ABP 501's safety, resulting in a score of 3."

Answered by AI

How many participants are being included in this research project?

"Presently, this clinical trial is not looking for new participants. The study was initially posted on October 4th 2021 and was most recently edited on November 16th 2022. For individuals searching for other studies, there are presently 179 studies actively seeking enrolment from patients with psoriasis vulgaris (plaque psoriasis) and 52 studies recruiting ABP 501 patients."

Answered by AI

Is this trial also running in other states within the US?

"This study is taking place at 58 different sites, which are situated in locations such as Mason, Surrey and Palm Springs. To limit the amount of travel required, it is best to select a trial location that is close to your home."

Answered by AI

Are new patients being accepted into this trial now?

"Unfortunately, this particular clinical trial is not enrolling patients at the moment. As stated on clinicaltrials.gov, the last update was on November 16th, 2022 and the trial was originally posted October 4th, 2021. Although there are no other trials currently looking for participants, there are 231 other trials enrolling patients right now."

Answered by AI

Who would this clinical trial be appropriate for?

"This dermatology study only admits patients that have plaque psoriasis and are between 18-75 years old. There is space for around 425 individuals in the trial."

Answered by AI

Does this research require participants to be a certain age?

"The age range for patients eligible to enroll in this study is 18-75. Out of the 241 total clinical trials, 45 are for those under 18 and 196 are for patients 65 and over."

Answered by AI

Why was this research conducted?

"The objective of this study, which will be evaluated over a Week 28 (Pre-dose and Post-dose) through Week 30 time frame, is to Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of Adalimumab and ABP 501. Secondary outcomes include Percent Improvement in PASI From Baseline to Week 30 which is defined as The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling); each graded on a 0-4 scale (0 = clear; 1-4= increasing severity)"

Answered by AI

Are there comparable studies to ABP 501?

"The latest information shows that there are 52 clinical trials underway for ABP 501. Of these, 14 are in the final stage (Phase 3). The majority of these trials take place in London; however, there are 2122 locations worldwide where patients can participate in a trial."

Answered by AI

What medical conditions does ABP 501 target?

"ABP 501 is a medication used to treat ankylosing spondylitis, but it can also help patients with rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis."

Answered by AI
~121 spots leftby Apr 2025