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Trial record 1 of 710 for:    ABP 501
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A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT05073315
Recruitment Status : Recruiting
First Posted : October 11, 2021
Last Update Posted : November 18, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE September 29, 2021
First Posted Date  ICMJE October 11, 2021
Last Update Posted Date November 18, 2021
Actual Study Start Date  ICMJE October 4, 2021
Estimated Primary Completion Date October 26, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2021)
  • Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of Adalimumab and ABP 501 [ Time Frame: Week 28 (Pre-dose and Post-dose) through Week 30 ]
    To evaluate similarity of AUCtau in participants after multiple switches between adalimumab and ABP 501, compared to participants receiving continued-use of adalimumab.
  • Maximum Concentration (Cmax) of Adalimumab and ABP 501 [ Time Frame: Week 28 (Pre-dose and Post-dose) through Week 30 ]
    To evaluate similarity of Cmax in participants after multiple switches between adalimumab and ABP 501, compared to participants receiving continued-use of adalimumab.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2021)
  • Time of Maximum Concentration (tmax) of Adalimumab and ABP 501 [ Time Frame: Week 28 (Pre-dose and Post-dose) through Week 30 ]
    To evaluate tmax in participants after multiple switches between adalimumab and ABP 501, compared to participants receiving continued-use of adalimumab.
  • Trough Concentration (Ctrough) of Adalimumab and ABP 501 [ Time Frame: Week 14 through Week 28 (Pre-dose and Post-dose) ]
    To evaluate Ctrough in participants after multiple switches between adalimumab and ABP 501, compared to participants receiving continued-use of adalimumab.
  • Percent Improvement in PASI From Baseline to Week 30 [ Time Frame: Baseline (Day 1) through Week 30 ]
    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 30 [ Time Frame: At Week 30 ]
    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 90 Response at Week 30 [ Time Frame: At Week 30 ]
    Reduction in disease as measured by PASI score. The PASI 90 response is a 90% or greater improvement (reduction in disease [PASI 90]) 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 30 [ Time Frame: At Week 30 ]
    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 Related Adverse Events (TEAEs) [ Time Frame: From Screening (≤ 28 days) through Week 32 or End of Study ]
    To assess the safety in participants after multiple switches between ABP 501 and adalimumab compared with participants receiving continued-use of adalimumab.
  • Number of Participants With Events of Interest [ Time Frame: From Screening (≤ 28 days) through Week 32 or End of Study ]
    To assess the safety in participants after multiple switches between ABP 501 and adalimumab compared with participants receiving continued-use of adalimumab.
  • Percentage of participants with Anti-drug Antibodies (ADA)/Neutralizing Antibodies (Nab) over time [ Time Frame: Baseline (Day 1) through Week 32 (Pre-dose) or End of Study ]
    To assess the immunogenicity in participants after multiple switches between ABP 501 and adalimumab compared with participants receiving continued-use of adalimumab.
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 Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Study is double-blind.
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: Adalimumab
    Participants will receive subcutaneous (SC) injection of adalimumab
    Other Name: Humira®
  • Drug: ABP 501
    Participants will receive SC injection of ABP 501
Study Arms  ICMJE
  • Active Comparator: Continued-use Group (Adalimumab)
    Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.
    Intervention: Drug: Adalimumab
  • Experimental: Switching Group (Adalimumab - ABP 501)
    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.
    Interventions:
    • Drug: Adalimumab
    • Drug: ABP 501
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 29, 2021)
414
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 26, 2023
Estimated Primary Completion Date October 26, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants has moderate to severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months and has stable disease for at least 2 months
  • Participants has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA) and static Physician's Global Assessment (sPGA) ≥ 3 at screening and at baseline
  • Participant has no known history of latent or active tuberculosis

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 received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment
  • Participant has received nonbiologic systemic psoriasis therapy within 4 weeks prior to enrollment
  • Participant has received ultraviolet (UV) A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks prior to enrollment
  • Participant has received topical psoriasis treatment within 2 weeks prior to enrollment
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05073315
Other Study ID Numbers  ICMJE 20200497
2021-000542-18 ( 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 November 2021

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