Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04761627
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE February 16, 2021
First Posted Date  ICMJE February 21, 2021
Last Update Posted Date September 16, 2021
Actual Study Start Date  ICMJE March 24, 2021
Estimated Primary Completion Date March 20, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2021)
  • Area Under the Curve from Time 0 over the Dosing Interval (AUCtau) [ Time Frame: Week 52 (pre-dose and post-dose) until Week 64 ]
    To evaluate AUCtau in participants with multiple switches between ustekinumab and ABP 654 compared to participants receiving continued use of ustekinumab.
  • Maximum Concentration (Cmax) [ Time Frame: Week 52 (pre-dose and post-dose) until Week 64 ]
    To evaluate Cmax in participants with multiple switches between ustekinumab and ABP 654 compared to participants receiving continued use of ustekinumab.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2021)
  • Time of Maximum Concentration (tmax) [ Time Frame: Week 52 (pre-dose and post-dose) until Week 64 ]
    To assess the tmax in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.
  • Trough Concentration at Steady State (Ctrough,ss) [ Time Frame: Week 28 (pre-dose and post-dose) until Week 52 (pre-dose and post-dose) ]
    To assess the Ctrough,ss in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.
  • Percent Improvement in PASI From Baseline to Week 64 [ Time Frame: Baseline (Day 1) until Week 64 ]
    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) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity.
  • Percentage of Participants with PASI 75 Response at Week 64 [ Time Frame: Week 64 ]
    Reduction in disease as measured by PASI score. The PASI 75 response is a 75% or greater improvement (reduction in disease [PASI 75]) from baseline in PASI score. 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) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity.
  • Percentage of Participants with PASI 100 Response at Week 64 [ Time Frame: Week 64 ]
    Reduction in disease as measured by PASI score. The PASI 100 response is a 100% improvement (reduction in disease [PASI 100]) from baseline in PASI score. 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) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity.
  • Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events [ Time Frame: Week 28 until Week 64 ]
    To assess the safety in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.
  • Number of Participants With Events of Interest [ Time Frame: Week 28 until Week 64 ]
    To assess the safety in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.
  • Number of Participants With Positive Anti-drug Antibodies to ABP 654 [ Time Frame: Week 28 until Week 64 (Pre-dose) ]
    To assess the immunogenicity in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Official Title  ICMJE 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
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 in participants with moderate to severe plaque psoriasis.
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 ustekinumab or multiple switches between ustekinumab and ABP 654 at Week 28. The randomization will be stratified by prior biologic use for psoriasis (yes versus [vs] no) at baseline (Week 0), geographic region, and baseline (Week 0) body weight.

All participants will receive an initial 3 doses of ustekinumab on Day 1 (Week 0), Week 4 and Week 16. At Week 28, participants will be randomized to continue on ustekinumab or switching between ABP 654 and ustekinumab every 12 weeks.

At Week 28, efficacy assessments will be conducted including evaluation of Psoriasis and Area Severity Index (PASI). Participants who do not achieve PASI 50 response or better improvement at Week 28 will be considered as run-in failures and will not be randomized at Week 28; these participants will complete End of Study procedures at Week 28. The run-in period will occur from Day 1 until randomization at Week 28. Those unable to complete the Week 28 visit or did not have a PASI assessment completed at Week 28 will be discontinued from the study.

The total duration of study participation for each participant will be 68 weeks, with up to 4 weeks for screening and 64 weeks after the first investigational product administration.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
The investigators, study personnel (with the exception of the Data Monitoring Committee (DMC), and unblinded Parexel staff supporting DMC activities and randomization list activities) and the study participants will remain blinded to treatment allocation. ABP 654 and ustekinumab will be coded and labeled in a manner that protects blinding.
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Ustekinumab
    Participants will receive subcutaneous (SC) injection of ustekinumab.
    Other Name: Stelara®
  • Drug: ABP 654
    Participants will receive SC injection of ABP 654.
Study Arms  ICMJE
  • Active Comparator: Continued-use Group (Ustekinumab)
    Participants will receive subcutaneous injection of ustekinumab up to Week 52.
    Intervention: Drug: Ustekinumab
  • Experimental: Switching Group (Ustekinumab - ABP 654)
    Participants will initially receive injection of ustekinumab up to Week 16. Thereafter, starting from Week 28, participants will switch between ABP 654 and ustekinumab every 12 weeks up to Week 52.
    Interventions:
    • Drug: Ustekinumab
    • Drug: ABP 654
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2021)
480
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2021)
352
Estimated Study Completion Date  ICMJE March 20, 2023
Estimated Primary Completion Date March 20, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries  ICMJE Canada,   Estonia,   Germany,   Hungary,   Latvia,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04761627
Other Study ID Numbers  ICMJE 20200417
2020-005205-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: http://www.amgen.com/datasharing
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP