CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 425 enrolled
Drug / intervention
Adalimumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05073315
NCT05073315Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (Adalimumab [US]) and ABP 501 Compared With Continued Use of Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis

Amgen·interventional·Posted Oct 11, 2021·Updated Feb 9, 2024

In Brief

A Phase 3 clinical trial evaluating Adalimumab and ABP 501 for Plaque Psoriasis. Completed, enrolled 425 participants across 88 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlaque Psoriasis
CountriesCanada, Estonia, Germany, Latvia, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedOct 11, 2021
Enrollment StartOct 4, 2021
Primary CompletionDec 19, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.7 years ago

Interventions

Adalimumabdrug

Participants will receive subcutaneous (SC) injection of adalimumab

ABP 501drug

Participants will receive SC injection of ABP 501