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A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adalimumab
ABP 501
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Adalimumab, Biosimilars, Tumor necrosis factor, Psoriasis Area and Severity Index

Eligibility Criteria

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

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

Sites / Locations

  • Total Skin and Beauty Dermatology Center PC
  • Johnson Dermatology Clinic
  • First OC Dermatology
  • Dermatology Research Associates
  • Clinical Science Institute
  • Unison Clinical Trials
  • Revival Research
  • Altus Research, Inc.
  • International Dermatology Research, Inc
  • Tory Sullivan MD PA
  • Marietta dermatology skin care
  • Georgia Skin and Cancer Clinic - Clinic
  • NorthShore University HealthSystem Dermatology
  • Deaconess Clinic Downtown
  • Lawrence J Green, MD, LLC
  • ALLCUTIS Research, LLC.
  • Metro Boston Clinical Partners
  • David Fivenson, MD, PLC
  • Henry Ford Health System - New Center One
  • Minnesota Clinical Study Center
  • Vivida Dermatology
  • Skin Search of Rochester, Inc.
  • Wilmington Dermatology Center
  • Wright State Physicians, Inc
  • Dermatologists of Southwest Ohio
  • Oregon Dermatology and Research Center
  • University of Pittsburgh Medical Center/Falk Medical Center
  • Clinical Research Center of the Carolinas
  • International Clinical Research - Tennessee LLC
  • Bellaire Dermatology Associates (BDA)
  • Center for Clinical Studies, LTD.LLP
  • Austin Institute for Clinical Research - Dermatology
  • Cutis Wellness Dermatology & Dermapathology, PLLC
  • Progressive Clinical Research [Texas]
  • Dermatology Clinical Research Center of San Antonio
  • Beacon Dermatology
  • Dr. Chih-ho Hong Medical Inc.
  • CCA Medical Research
  • SimcoDerm Medical & Surgical Dermatology Center
  • Kingsway Clinical Research
  • Guelph Dermatology Research
  • DermEffects
  • DermEdge Research Inc.
  • North Bay Dermatology Centre Inc.
  • The Centre for Clinical Trials Inc.
  • SKiN Centre for Dermatology
  • The Centre for Dermatology
  • Toronto Research Centre - Dermatology
  • XLR8 Medical Research Inc.
  • Dre Angélique Gagné-Henley MD inc
  • North Estonia Medical Centre
  • Clinical Research Center
  • Tartu University Hospital
  • Derma-Study-Center-FN
  • Klinische Forschung Gruppe Nord (KFGN)
  • Hautzentrum im Jahrhunderthaus
  • Klinische Forschung Dresden GmbH
  • UKSH Campus Kiel - ZeH (Dermatologie)
  • Rothhaar Studien GmbH
  • TFS Trial Form Support GmbH
  • Health Centre 4 Ltd., Diagnostics Centre
  • Riga 1st hospital, Clinic of Dermatology and STD
  • J.Kisis LtD
  • Health and Aesthetics Ltd
  • Smite Aija doctor practice in dermatology, venereology
  • High-Med Przychodnia Specjalistyczna
  • Royalderm Agnieszka Nawrocka
  • ClinicMed Daniluk, Nowak Sp. J.
  • Centrum Badan Klinicznych PI-House Sp. z o.o.
  • Care Clinic SP. Z O.O.
  • Centrum Medyczne Angelius Provita
  • Pratia MCM Krakow
  • Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.
  • NZOZ ALL-MED Centrum Medyczne
  • Centrum Terapii Wspolczesnej, J.M. Jasnorzewska S.K.A.
  • Centrum Zdrowia i Urody Maxxmed
  • ETG Lublin
  • Agnieszka Miasik-Pogodzinska DrDerm Centrum Medyczne
  • Dermedic Jacek Zdybski
  • Solumed Centrum Medyczne
  • Clinical Research Center Sp. z o.o., Medic-R Sp. K.
  • Poradnia Dermatologiczno-Wenerologiczna MEDIDERM NZOZ
  • RCMed Oddzia Warszawa
  • Carpe Diem Centrum Medycyny Estetycznej
  • Klinika Ambroziak Dermatologia
  • Ginemedica Sp. z o.o. Sp.k
  • WroMedica I. Bielicka, A. Strzalkowska s.c.
  • Centrum Medyczne Oporow

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continued-use Group (Adalimumab)

Switching Group (Adalimumab - ABP 501)

Arm Description

Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.

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.

Outcomes

Primary Outcome Measures

Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of Adalimumab and ABP 501
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
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

Time of Maximum Concentration (tmax) of Adalimumab and ABP 501
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
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
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
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
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
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)
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
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
To assess the immunogenicity in participants after multiple switches between ABP 501 and adalimumab compared with participants receiving continued-use of adalimumab.

Full Information

First Posted
September 29, 2021
Last Updated
January 4, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05073315
Brief Title
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
December 19, 2022 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Adalimumab, Biosimilars, Tumor necrosis factor, Psoriasis Area and Severity Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Study is double-blind.
Allocation
Randomized
Enrollment
425 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continued-use Group (Adalimumab)
Arm Type
Active Comparator
Arm Description
Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.
Arm Title
Switching Group (Adalimumab - ABP 501)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira®
Intervention Description
Participants will receive subcutaneous (SC) injection of adalimumab
Intervention Type
Drug
Intervention Name(s)
ABP 501
Intervention Description
Participants will receive SC injection of ABP 501
Primary Outcome Measure Information:
Title
Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of Adalimumab and ABP 501
Description
To evaluate similarity of AUCtau in participants after multiple switches between adalimumab and ABP 501, compared to participants receiving continued-use of adalimumab.
Time Frame
Week 28 (Pre-dose and Post-dose) through Week 30
Title
Maximum Concentration (Cmax) of Adalimumab and ABP 501
Description
To evaluate similarity of Cmax in participants after multiple switches between adalimumab and ABP 501, compared to participants receiving continued-use of adalimumab.
Time Frame
Week 28 (Pre-dose and Post-dose) through Week 30
Secondary Outcome Measure Information:
Title
Time of Maximum Concentration (tmax) of Adalimumab and ABP 501
Description
To evaluate tmax in participants after multiple switches between adalimumab and ABP 501, compared to participants receiving continued-use of adalimumab.
Time Frame
Week 28 (Pre-dose and Post-dose) through Week 30
Title
Trough Concentration (Ctrough) of Adalimumab and ABP 501
Description
To evaluate Ctrough in participants after multiple switches between adalimumab and ABP 501, compared to participants receiving continued-use of adalimumab.
Time Frame
Week 14 through Week 28 (Pre-dose and Post-dose)
Title
Percent Improvement in PASI From Baseline to Week 30
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) through Week 30
Title
Percentage of Participants with PASI 75 Response at Week 30
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
At Week 30
Title
Percentage of Participants with PASI 90 Response at Week 30
Description
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.
Time Frame
At Week 30
Title
Percentage of Participants with PASI 100 Response at Week 30
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
At Week 30
Title
Number of Participants With Treatment Related Adverse Events (TEAEs)
Description
To assess the safety in participants after multiple switches between ABP 501 and adalimumab compared with participants receiving continued-use of adalimumab.
Time Frame
From Screening (≤ 28 days) through Week 32 or End of Study
Title
Number of Participants With Events of Interest
Description
To assess the safety in participants after multiple switches between ABP 501 and adalimumab compared with participants receiving continued-use of adalimumab.
Time Frame
From Screening (≤ 28 days) through Week 32 or End of Study
Title
Percentage of participants with Anti-drug Antibodies (ADA)/Neutralizing Antibodies (Nab) over time
Description
To assess the immunogenicity in participants after multiple switches between ABP 501 and adalimumab compared with participants receiving continued-use of adalimumab.
Time Frame
Baseline (Day 1) through Week 32 (Pre-dose) or End of Study

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Johnson Dermatology Clinic
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Unison Clinical Trials
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Revival Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
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
Tory Sullivan MD PA
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162-4708
Country
United States
Facility Name
Marietta dermatology skin care
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Georgia Skin and Cancer Clinic - Clinic
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31419
Country
United States
Facility Name
NorthShore University HealthSystem Dermatology
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Deaconess Clinic Downtown
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47708
Country
United States
Facility Name
Lawrence J Green, MD, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
ALLCUTIS Research, LLC.
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Metro Boston Clinical Partners
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
David Fivenson, MD, PLC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Henry Ford Health System - New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Vivida Dermatology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Skin Search of Rochester, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Wilmington Dermatology Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
Wright State Physicians, Inc
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
Dermatologists of Southwest Ohio
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University of Pittsburgh Medical Center/Falk Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Clinical Research Center of the Carolinas
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
International Clinical Research - Tennessee LLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Bellaire Dermatology Associates (BDA)
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401-3505
Country
United States
Facility Name
Center for Clinical Studies, LTD.LLP
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Austin Institute for Clinical Research - Dermatology
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Cutis Wellness Dermatology & Dermapathology, PLLC
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Progressive Clinical Research [Texas]
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Beacon Dermatology
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Facility Name
Dr. Chih-ho Hong Medical Inc.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
CCA Medical Research
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
SimcoDerm Medical & Surgical Dermatology Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Kingsway Clinical Research
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M8X 1Y9
Country
Canada
Facility Name
Guelph Dermatology Research
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1L 0B7
Country
Canada
Facility Name
DermEffects
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
DermEdge Research Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Facility Name
North Bay Dermatology Centre Inc.
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
The Centre for Clinical Trials Inc.
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
SKiN Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
Toronto Research Centre - Dermatology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Facility Name
XLR8 Medical Research Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Dre Angélique Gagné-Henley MD inc
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Facility Name
North Estonia Medical Centre
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
13419
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
Derma-Study-Center-FN
City
Friedrichshafen
State/Province
Baden-Württemberg
ZIP/Postal Code
88045
Country
Germany
Facility Name
Klinische Forschung Gruppe Nord (KFGN)
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19055
Country
Germany
Facility Name
Hautzentrum im Jahrhunderthaus
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44793
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01069
Country
Germany
Facility Name
UKSH Campus Kiel - ZeH (Dermatologie)
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Rothhaar Studien GmbH
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
TFS Trial Form Support GmbH
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Facility Name
Health Centre 4 Ltd., Diagnostics Centre
City
Riga
State/Province
Rga
ZIP/Postal Code
LV-1003
Country
Latvia
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
Health and Aesthetics Ltd
City
Riga
ZIP/Postal Code
LV-1009
Country
Latvia
Facility Name
Smite Aija doctor practice in dermatology, venereology
City
Talsi
ZIP/Postal Code
LV3201
Country
Latvia
Facility Name
High-Med Przychodnia Specjalistyczna
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-817
Country
Poland
Facility Name
Royalderm Agnieszka Nawrocka
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-962
Country
Poland
Facility Name
ClinicMed Daniluk, Nowak Sp. J.
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House Sp. z o.o.
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Care Clinic SP. Z O.O.
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Facility Name
Centrum Medyczne Angelius Provita
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Pratia MCM Krakow
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.
City
Krakow
ZIP/Postal Code
31-011
Country
Poland
Facility Name
NZOZ ALL-MED Centrum Medyczne
City
Lodz
ZIP/Postal Code
90-048
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej, J.M. Jasnorzewska S.K.A.
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Centrum Zdrowia i Urody Maxxmed
City
Lublin
ZIP/Postal Code
20-080
Country
Poland
Facility Name
ETG Lublin
City
Lublin
ZIP/Postal Code
20-412
Country
Poland
Facility Name
Agnieszka Miasik-Pogodzinska DrDerm Centrum Medyczne
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Dermedic Jacek Zdybski
City
Ostrowiec Swietokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Solumed Centrum Medyczne
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
City
Poznan
ZIP/Postal Code
61-731
Country
Poland
Facility Name
Poradnia Dermatologiczno-Wenerologiczna MEDIDERM NZOZ
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
RCMed Oddzia Warszawa
City
Warszawa
ZIP/Postal Code
00-892
Country
Poland
Facility Name
Carpe Diem Centrum Medycyny Estetycznej
City
Warszawa
ZIP/Postal Code
02-661
Country
Poland
Facility Name
Klinika Ambroziak Dermatologia
City
Warszawa
ZIP/Postal Code
02-953
Country
Poland
Facility Name
Ginemedica Sp. z o.o. Sp.k
City
Wroclaw
ZIP/Postal Code
50-414
Country
Poland
Facility Name
WroMedica I. Bielicka, A. Strzalkowska s.c.
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Centrum Medyczne Oporow
City
Wroclaw
ZIP/Postal Code
52-416
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 Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

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