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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

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

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

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 more

Side effects data

From 2016 Phase 3 trial • 467 Patients • NCT02114931

Upper respiratory tract infection

Nasopharyngitis

Hypertension

Bronchitis

Pharyngitis

Rheumatoid arthritis

Myocardial infarction

Osteoarthritis

100%

80%

60%

40%

20%

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