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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ustekinumab
ABP 654
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Biosimilar, Psoriasis area and severity index, Ustekinumab, Skin Diseases, Dermatologic Agents, Papulosquamous

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Burke Pharmaceutical Research
  • Zenith Research Inc.
  • Center for Dermatology Clinical Research, Inc.
  • Quest Dermatology Research
  • Southern California Dermatology, Inc
  • Encore Research Group-Jacksonville Center for Clinical Resea
  • Altus Research, Inc.
  • International Dermatology Research, Inc.
  • Leavitt Medical Associates of Florida d/b/a Ameriderm Research
  • Riverchase Dermatology and Cosmetic Surgery
  • Olympian Clinical Research
  • Hamilton Research, LLC
  • Advanced Medical Research PC
  • Dundee Dermatology
  • DS Research
  • Integrated Clinical Trial Services Inc.
  • Kansas Medical Clinic, PA
  • Clinical Pharmacology Study Group
  • Hamzavi Dermatology
  • Minnesota Clinical Study Center
  • MediSearch Clinical Trials
  • Skin Specialists PC
  • ActivMed Practices & Research, LLC.
  • Psoriasis Treatment Center of Central New Jersey
  • The Dermatology Group, PC
  • Wilmington Dermatology Center
  • Oregon Medical Research Center
  • Austin Institute for Clinical Research, Inc.
  • Austin Institute for Clinical Research, Inc - Dermatology
  • Progressive Clinical Research [Texas]
  • Center for Clinical Studies, LTD., LLP
  • Enverus Medical Research
  • Wiseman Dermatology Research Inc.
  • Dr. Irina Turchin PC Inc.
  • CCA Medical Research
  • SimcoDerm Medical and Surgical Dermatology Center
  • Guelph Dermatology Research
  • Dr Wei Jing Loo Medicine Professional Corporation
  • Lynderm Research Inc
  • DermEdge Research Inc.
  • Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office
  • North York Research Inc. - Dermatology
  • Dermatology Ottawa Research Centre
  • Research Toronto
  • K. Papp Clinical Research Inc.
  • Confido Private Medical Clinic - General Practice/Medicine
  • Clinical Research Center
  • Tartu University Hospital
  • Innomedica OÜ
  • Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
  • LTD Israeli-Georgian Medical Research Clinic Helsicore
  • ,,Tbilisi Cancer center"LTD
  • LTD Aversi Clinic
  • ,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC
  • Derma-Study-Center-FN
  • Dermazentrum Augsburg
  • Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
  • Universitätsklinikum Frankfurt am Main - Klinik für Dermatol
  • Fachklinik Bad Bentheim
  • Praxis Hoffmann
  • Klinische Forschung Dresden GmbH
  • Universitätsklinikum Carl Gustav Carus
  • UK-SH - Lübeck
  • Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie
  • Rothhaar Studien GmbH
  • Debreceni Egyetem Klinikai Központ Nagyerdei Campus
  • Brgyógyászati és Allergológiai Magánrendelés
  • Qualiclinic Kft
  • UNOMEDICALTRIALS Kft
  • Riga 1st hospital, Clinic of Dermatology and STD
  • J.Kisis LtD
  • Smite Aija doctor practice in dermatology, venereology
  • Centrum Medyczne ALL-MED Badania Kliniczne
  • Centrum Medyczne Plejady
  • MICS Centrum Medyczne Warszawa
  • RENEW CLINIC Spolka Jawna
  • MICS Centrum Medyczne Bydgoszcz
  • Centrum Medyczne Pratia Bydgoszcz
  • Centrum Medyczne Pratia Gdynia
  • Krakowskie Centrum Medyczne Sp. z o.o.
  • Centrum Medyczne PROMED
  • Barbara Rewerska Diamond Clinic
  • ETG Siedlce
  • RCMed Oddzial Sochaczew
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • RCMed Oddzia Warszawa
  • Centrum Medyczne Evimed
  • DermMedica Sp. z o.o.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continued-use Group (Ustekinumab)

Switching Group (Ustekinumab - ABP 654)

Arm Description

Participants will receive subcutaneous injection of ustekinumab up to Week 52.

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.

Outcomes

Primary Outcome Measures

Area Under the Curve from Time 0 over the Dosing Interval (AUCtau)
To evaluate AUCtau in participants with multiple switches between ustekinumab and ABP 654 compared to participants receiving continued use of ustekinumab.
Maximum Concentration (Cmax)
To evaluate Cmax in participants with multiple switches between ustekinumab and ABP 654 compared to participants receiving continued use of ustekinumab.

Secondary Outcome Measures

Time of Maximum Concentration (tmax)
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)
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
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
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
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
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
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
To assess the immunogenicity in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.

Full Information

First Posted
February 16, 2021
Last Updated
September 14, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04761627
Brief Title
A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, Biosimilar, Psoriasis area and severity index, Ustekinumab, Skin Diseases, Dermatologic Agents, Papulosquamous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
494 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continued-use Group (Ustekinumab)
Arm Type
Active Comparator
Arm Description
Participants will receive subcutaneous injection of ustekinumab up to Week 52.
Arm Title
Switching Group (Ustekinumab - ABP 654)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Other Intervention Name(s)
Stelara®
Intervention Description
Participants will receive subcutaneous (SC) injection of ustekinumab.
Intervention Type
Drug
Intervention Name(s)
ABP 654
Intervention Description
Participants will receive SC injection of ABP 654.
Primary Outcome Measure Information:
Title
Area Under the Curve from Time 0 over the Dosing Interval (AUCtau)
Description
To evaluate AUCtau in participants with multiple switches between ustekinumab and ABP 654 compared to participants receiving continued use of ustekinumab.
Time Frame
Week 52 (pre-dose and post-dose) until Week 64
Title
Maximum Concentration (Cmax)
Description
To evaluate Cmax in participants with multiple switches between ustekinumab and ABP 654 compared to participants receiving continued use of ustekinumab.
Time Frame
Week 52 (pre-dose and post-dose) until Week 64
Secondary Outcome Measure Information:
Title
Time of Maximum Concentration (tmax)
Description
To assess the tmax in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.
Time Frame
Week 52 (pre-dose and post-dose) until Week 64
Title
Trough Concentration at Steady State (Ctrough,ss)
Description
To assess the Ctrough,ss in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.
Time Frame
Week 28 (pre-dose and post-dose) until Week 52 (pre-dose and post-dose)
Title
Percent Improvement in PASI From Baseline to Week 64
Description
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.
Time Frame
Baseline (Day 1) until Week 64
Title
Percentage of Participants with PASI 75 Response at Week 64
Description
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.
Time Frame
Week 64
Title
Percentage of Participants with PASI 100 Response at Week 64
Description
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.
Time Frame
Week 64
Title
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Description
To assess the safety in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.
Time Frame
Week 28 until Week 64
Title
Number of Participants With Events of Interest
Description
To assess the safety in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.
Time Frame
Week 28 until Week 64
Title
Number of Participants With Positive Anti-drug Antibodies to ABP 654
Description
To assess the immunogenicity in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.
Time Frame
Week 28 until Week 64 (Pre-dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Zenith Research Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Quest Dermatology Research
City
Northridge
State/Province
California
ZIP/Postal Code
91324-4669
Country
United States
Facility Name
Southern California Dermatology, Inc
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Encore Research Group-Jacksonville Center for Clinical Resea
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Altus Research, Inc.
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Riverchase Dermatology and Cosmetic Surgery
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028-1013
Country
United States
Facility Name
Olympian Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Hamilton Research, LLC
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Advanced Medical Research PC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Dundee Dermatology
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Facility Name
DS Research
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129
Country
United States
Facility Name
Integrated Clinical Trial Services Inc.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Kansas Medical Clinic, PA
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66614
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Skin Specialists PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
ActivMed Practices & Research, LLC.
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
The Dermatology Group, PC
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Wilmington Dermatology Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Austin Institute for Clinical Research, Inc.
City
Dripping Springs
State/Province
Texas
ZIP/Postal Code
78620
Country
United States
Facility Name
Austin Institute for Clinical Research, Inc - Dermatology
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Progressive Clinical Research [Texas]
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Center for Clinical Studies, LTD., LLP
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Enverus Medical Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Dr. Irina Turchin PC Inc.
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
CCA Medical Research
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
SimcoDerm Medical and Surgical Dermatology Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Guelph Dermatology Research
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1L 0B7
Country
Canada
Facility Name
Dr Wei Jing Loo Medicine Professional Corporation
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Facility Name
DermEdge Research Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Facility Name
Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
North York Research Inc. - Dermatology
City
North York
State/Province
Ontario
ZIP/Postal Code
M2M 4J5
Country
Canada
Facility Name
Dermatology Ottawa Research Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3N2
Country
Canada
Facility Name
Research Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N4
Country
Canada
Facility Name
K. Papp Clinical Research Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Confido Private Medical Clinic - General Practice/Medicine
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Clinical Research Center
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50106
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50417
Country
Estonia
Facility Name
Innomedica OÜ
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
City
Tbilisi
State/Province
T'bilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LTD Israeli-Georgian Medical Research Clinic Helsicore
City
Tbilisi
State/Province
T'bilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
,,Tbilisi Cancer center"LTD
City
Tbilisi
State/Province
T'bilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
LTD Aversi Clinic
City
Tbilisi
State/Province
T'bilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Derma-Study-Center-FN
City
Friedrichshafen
State/Province
Baden-Württemberg
ZIP/Postal Code
88045
Country
Germany
Facility Name
Dermazentrum Augsburg
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86179
Country
Germany
Facility Name
Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
City
Mahlow
State/Province
Brandenburg
ZIP/Postal Code
15831
Country
Germany
Facility Name
Universitätsklinikum Frankfurt am Main - Klinik für Dermatol
City
Frankfurt/Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
State/Province
Niedersachsen
ZIP/Postal Code
48455
Country
Germany
Facility Name
Praxis Hoffmann
City
Witten
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58453
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01069
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
UK-SH - Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Rothhaar Studien GmbH
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
Debreceni Egyetem Klinikai Központ Nagyerdei Campus
City
Debrecen
State/Province
Hajdú-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Brgyógyászati és Allergológiai Magánrendelés
City
Szolnok
State/Province
Jász-Nagykun-Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Qualiclinic Kft
City
Budapest
State/Province
Pest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
UNOMEDICALTRIALS Kft
City
Budapest
State/Province
Pest
ZIP/Postal Code
1152
Country
Hungary
Facility Name
Riga 1st hospital, Clinic of Dermatology and STD
City
Riga
State/Province
Rga
ZIP/Postal Code
LV1001
Country
Latvia
Facility Name
J.Kisis LtD
City
Riga
State/Province
Rga
ZIP/Postal Code
LV1003
Country
Latvia
Facility Name
Smite Aija doctor practice in dermatology, venereology
City
Talsi
ZIP/Postal Code
LV3201
Country
Latvia
Facility Name
Centrum Medyczne ALL-MED Badania Kliniczne
City
Krakow
State/Province
Maopolskie
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Krakow
State/Province
Maopolskie
ZIP/Postal Code
30-363
Country
Poland
Facility Name
MICS Centrum Medyczne Warszawa
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-874
Country
Poland
Facility Name
RENEW CLINIC Spolka Jawna
City
Bialystok
ZIP/Postal Code
15-794
Country
Poland
Facility Name
MICS Centrum Medyczne Bydgoszcz
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Facility Name
Centrum Medyczne Pratia Bydgoszcz
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Centrum Medyczne Pratia Gdynia
City
Gdynia
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Krakowskie Centrum Medyczne Sp. z o.o.
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Centrum Medyczne PROMED
City
Krakow
ZIP/Postal Code
31-513
Country
Poland
Facility Name
Barbara Rewerska Diamond Clinic
City
Krakow
ZIP/Postal Code
31-559
Country
Poland
Facility Name
ETG Siedlce
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
RCMed Oddzial Sochaczew
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
RCMed Oddzia Warszawa
City
Warszawa
ZIP/Postal Code
00-892
Country
Poland
Facility Name
Centrum Medyczne Evimed
City
Warszawa
ZIP/Postal Code
02-625
Country
Poland
Facility Name
DermMedica Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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