CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 494 enrolled
Drug / intervention
Ustekinumab +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/NCT04761627
NCT04761627Phase 3Completed

A Multicenter, Randomized, Double-blinded Study Evaluating the Pharmacokinetics, Efficacy and Safety of Multiple Switches Between Ustekinumab and ABP 654 Compared With Continued Use of Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis

Amgen·interventional·Posted Feb 21, 2021·Updated Jan 11, 2024

In Brief

A Phase 3 clinical trial evaluating Ustekinumab and ABP 654 for Psoriasis. Completed, enrolled 494 participants across 88 sites in 8 countries.

Detailed Summary

The purpose of the study is to evaluate pharmacokinetic similarity, efficacy, safety and immunogenicity of multiple switches between ustekinumab and ABP 654 compared with continued use of ustekinumab in participants with moderate to severe plaque psoriasis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesCanada, Estonia, Georgia, Germany, Hungary, Latvia, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedFeb 21, 2021
Enrollment StartMar 24, 2021
Primary CompletionFeb 28, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.4 years ago

Interventions

Ustekinumabdrug

Participants will receive subcutaneous (SC) injection of ustekinumab.

ABP 654drug

Participants will receive SC injection of ABP 654.