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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

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Adalimumab Drug: ABP 501 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Study is double-blind.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 4, 2021
Estimated Primary Completion Date : October 26, 2023
Estimated Study Completion Date : October 26, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

Arm Intervention/treatment
Active Comparator: Continued-use Group (Adalimumab)
Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.
Drug: Adalimumab
Participants will receive subcutaneous (SC) injection of adalimumab
Other Name: Humira®

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.
Drug: Adalimumab
Participants will receive subcutaneous (SC) injection of adalimumab
Other Name: Humira®

Drug: ABP 501
Participants will receive SC injection of ABP 501




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05073315


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, California
Dermatology Research Associates Recruiting
Los Angeles, California, United States, 90045
Unison Clinical Trials Recruiting
Sherman Oaks, California, United States, 91403
United States, Florida
Revival Research Recruiting
Doral, Florida, United States, 33122
United States, Georgia
Georgia Skin and Cancer Clinic - Clinic Recruiting
Savannah, Georgia, United States, 31419
United States, Massachusetts
Metro Boston Clinical Partners Recruiting
Brighton, Massachusetts, United States, 02135
United States, New York
Skin Search of Rochester, Inc. Recruiting
Rochester, New York, United States, 14623
United States, North Carolina
Wilmington Dermatology Center Recruiting
Wilmington, North Carolina, United States, 28405
United States, South Carolina
Clinical Research Center of the Carolinas Recruiting
Charleston, South Carolina, United States, 29407
United States, Tennessee
International Clinical Research - Tennessee LLC Recruiting
Murfreesboro, Tennessee, United States, 37130
United States, Texas
Austin Institute for Clinical Research - Dermatology Recruiting
Houston, Texas, United States, 77056
Cutis Wellness Dermatology & Dermapathology, PLLC Recruiting
Laredo, Texas, United States, 78041
Progressive Clinical Research [Texas] Recruiting
San Antonio, Texas, United States, 78213
Dermatology Clinical Research Center of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT05073315    
Other Study ID Numbers: 20200497
2021-000542-18 ( EudraCT Number )
First Posted: October 11, 2021    Key Record Dates
Last Update Posted: November 18, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Adalimumab
Biosimilars
Tumor necrosis factor
Psoriasis Area and Severity Index
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents