Status:
COMPLETED
A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
Amgen
Conditions:
Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This is a multi-center study and will enroll approximately 480 participants. After eligibility confirmation, all participants will be randomized in a 1:1 ratio into 2 treatment arms: continued use of...
Eligibility Criteria
Inclusion
- Participant has stable moderate to severe plaque psoriasis for at least 6 months
- Participant has a score of PASI ≥ 12, involvement of ≥ 10% body surface area and static Physician Global Assessment ≥ 3 at screening and at baseline
- Participant is a candidate for phototherapy or systemic therapy
- Participant has previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy
- Female participant should have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline
- Participant or legally acceptable representative is capable of giving signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) informed consent
- Participant has no known history of latent or active tuberculosis
- Participant with a positive purified protein derivative (PPD) test and a history of Bacillus Calmette-Guérin (BCG) vaccination is allowed with a negative Quantiferon/T-spot test
- Participant with a positive PPD test or participant with a positive or indeterminate Quantiferon/T-spot test is allowed if he/she has all the following:
- No symptoms per tuberculosis worksheet provided by the sponsor, Amgen Inc.
- Documented history of adequate prophylaxis initiation prior to receiving investigational product in accordance with local recommendations
- No known exposure to a case of active tuberculosis after most recent prophylaxis
- No evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product
Exclusion
- Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication induced psoriasis, or other skin conditions at the time of screening (eg, eczema) that would interfere with evaluations of the effect of investigational product of psoriasis
- Participant has an active infection or history of infections
- Participant has uncontrolled, clinically significant systemic disease, such as uncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease, or hypertension
- Participant has a mean QT internal or abnormal long QT syndrome corrected using Fridericia's formula (QTcF) of \> 450 msec (for male participant) or \> 470 msec (for female participant) at baseline that, in the opinion of the Investigator, is abnormal or clinically significant
- Participant has moderate to severe heart failure (New York Heart Associate class III/IV)
- Participant has known hypersensitivity to the investigational product or to any of the excipients
- Participant has laboratory abnormalities at screening
- Participant has had previous treatment with any agent specifically targeting interleukin (IL)-12 or IL-23 within 1 year prior to enrollment
- Participant has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment
- Participant has received any investigational agents within the previous month or 5 half-lives (whichever is longer) prior to enrollment
- Participant has received non-biologic systemic psoriasis therapy within 4 weeks prior to enrollment
- Participant has received ultraviolet A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or ultraviolet B phototherapy within 2 weeks prior to enrollment
- Participant has received topical psoriasis treatment within 2 weeks prior to enrollment
- Participant has received other investigational procedures within 4 weeks prior to enrollment and during the course of the study
- Female participant is pregnant or breastfeeding or planning to become pregnant while participating in the study and for at least 5 months after the last dose of investigational product
- Sexually active participants and their partners who are of childbearing potential and not agreeing to use adequate protocol defined contraception methods while participating in the study and for 5 months after the last dose of investigational product
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT04761627
Start Date
March 24 2021
End Date
February 28 2023
Last Update
January 11 2024
Active Locations (88)
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1
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
2
Zenith Research Inc.
Beverly Hills, California, United States, 90212
3
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
4
Quest Dermatology Research
Northridge, California, United States, 91324-4669