Back to resultsA Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis
Primary Purpose
Psoriasis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cedirogant
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Plaque Psoriasis, Cedirogant, ABBV-157
Eligibility Criteria
Inclusion Criteria:
- Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.
Exclusion Criteria:
- Primary non-responders to previous anti-IL-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.
- Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.
Sites / Locations
- UAB Department of Dermatology /ID# 238563
- Medical Dermatology Specialist /ID# 238518
- Arkansas Research Trials /ID# 238687
- Encino Research Center /ID# 245950
- Velocity Clinical Research, Inc. /ID# 239536
- Medderm Associates /ID# 238834
- Lakes Research, LLC /ID# 238831
- Florida International Rsrch cr /ID# 245959
- Lenus Research & Medical Group /ID# 238695
- Advanced Clinical Research Institute /ID# 238697
- Clinical Research Trials of Florida, Inc. /ID# 238709
- ForCare Clinical Research /ID# 238856
- Cleaver Medical Group Dermatology - Dawsonville /ID# 246327
- Marietta Dermatology Clinical Research /ID# 238679
- Arlington Dermatology /ID# 238701
- Dawes Fretzin, LLC /ID# 238704
- Tulane University /ID# 238859
- Derm Institute of West Michigan /ID# 247341
- Zel Skin & Laser Specialists - Edina /ID# 238714
- Skin Specialists, PC /ID# 238514
- Forest Hills Dermatology Group /ID# 238708
- Buffalo Medical Group /ID# 239068
- Darst Dermatology /ID# 238677
- Wilmington Dermatology Center /ID# 246445
- Univ Hosp Cleveland /ID# 245953
- Dermatologists of Southwest Ohio, Inc /ID# 238939
- Oregon Dermatology and Research Center /ID# 238823
- University of Pittsburgh MC /ID# 246170
- Clinical Partners, LLC /ID# 238620
- Clinical Research Center of the Carolinas /ID# 238827
- Health Concepts /ID# 238510
- Tennessee Clinical Research Center /ID# 238682
- Arlington Research Center, Inc /ID# 244171
- Orion Clinical Research /ID# 238619
- Bellaire Dermatology /ID# 247865
- Center for Clinical Studies - Houston (Binz) /ID# 243700
- Progressive Clinical Research /ID# 238565
- Dermatology Specialists of Spokane /ID# 238809
- West Virginia Research /ID# 238517
- Dr. Chih-ho Hong Medical Inc. /ID# 238864
- Wiseman Dermatology Research /ID# 238867
- SimcoDerm Medical and Surgical Dermatology Center /ID# 238861
- Dr. Wei Jing Loo Medicine Prof /ID# 238865
- Lynderm Research Inc. /ID# 243199
- K. Papp Clinical Research /ID# 239695
- Nagoya City University Hospital /ID# 239286
- Takagi Dermatology Clinic /ID# 239274
- JR Sapporo Hospital /ID# 239277
- Mie University Hospital /ID# 239275
- Okayama University Hospital /ID# 239285
- Kansai Medical University Hospital /ID# 239278
- Hamamatsu University Hospital /ID# 239346
- The Jikei University Hospital /ID# 239319
- NTT Medical Center Tokyo /ID# 239287
- Tokyo Medical University Hospital /ID# 239320
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Arm 1: Cedirogant
Arm 2: Cedirogant
Arm 3: Cedirogant
Arm 4: Placebo
Arm Description
Participants will receive cedirogant Dose A once daily.
Participants will receive cedirogant Dose B once daily.
Participants will receive cedirogant Dose C once daily.
Participants will receive placebo once daily.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving >=75% Reduction from Baseline in Psoriasis Area Severity Index (PASI) score (PASI 75)
The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 to 72, with a higher score indicating more severe disease.
Secondary Outcome Measures
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Percentage of Participants Achieving >=50% Reduction from Baseline in PASI Score (PASI 50)
The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 to 72, with a higher score indicating more severe disease.
Percentage of Participants Achieving >=90% Reduction from Baseline in PASI Score (PASI 90)
The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 to 72, with a higher score indicating more severe disease.
Percentage of Participants Achieving 100% Reduction from Baseline in PASI Score (PASI 100)
The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 to 72, with a higher score indicating more severe disease.
Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 for Participants with PSS >0 at Baseline
The PSS is a 4-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis. Current symptom severity is assessed using a 5-point Likert-type scale ranging from 0 (none) to 4 (very severe).
Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) >=4-Point Improvement from Baseline for Participants with Itch NRS >=4 at Baseline
The Itch NRS is an 11-point scale that participants complete daily to describe the intensity of their itch using a 24-hour recall period. Scores vary between 0, representing "no itching" and 10, representing "worst itch imaginable."
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05044234
Brief Title
A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis
Official Title
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Cedirogant (ABBV-157) in Adult Subjects With Moderate to Severe Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Company Decision
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study will assess how safe and effective cedirogant (ABBV-157) is compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements are assessing disease activity in participants with plaque psoriasis.
Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants will be put into 1 of 4 groups, called treatment arms and each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Approximately 200 adult participants with moderate to severe plaque psoriasis will be enrolled at approximately 45 sites.
Participants will receive oral daily doses of cedirogant or placebo capsules for 16 weeks.
There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, Plaque Psoriasis, Cedirogant, ABBV-157
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Cedirogant
Arm Type
Experimental
Arm Description
Participants will receive cedirogant Dose A once daily.
Arm Title
Arm 2: Cedirogant
Arm Type
Experimental
Arm Description
Participants will receive cedirogant Dose B once daily.
Arm Title
Arm 3: Cedirogant
Arm Type
Experimental
Arm Description
Participants will receive cedirogant Dose C once daily.
Arm Title
Arm 4: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo once daily.
Intervention Type
Drug
Intervention Name(s)
Cedirogant
Other Intervention Name(s)
ABBV-157
Intervention Description
Capsule, Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule, Oral
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving >=75% Reduction from Baseline in Psoriasis Area Severity Index (PASI) score (PASI 75)
Description
The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 to 72, with a higher score indicating more severe disease.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear
Description
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time Frame
Week 16
Title
Percentage of Participants Achieving >=50% Reduction from Baseline in PASI Score (PASI 50)
Description
The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 to 72, with a higher score indicating more severe disease.
Time Frame
Week 16
Title
Percentage of Participants Achieving >=90% Reduction from Baseline in PASI Score (PASI 90)
Description
The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 to 72, with a higher score indicating more severe disease.
Time Frame
Week 16
Title
Percentage of Participants Achieving 100% Reduction from Baseline in PASI Score (PASI 100)
Description
The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 to 72, with a higher score indicating more severe disease.
Time Frame
Week 16
Title
Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 for Participants with PSS >0 at Baseline
Description
The PSS is a 4-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis. Current symptom severity is assessed using a 5-point Likert-type scale ranging from 0 (none) to 4 (very severe).
Time Frame
Week 16
Title
Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) >=4-Point Improvement from Baseline for Participants with Itch NRS >=4 at Baseline
Description
The Itch NRS is an 11-point scale that participants complete daily to describe the intensity of their itch using a 24-hour recall period. Scores vary between 0, representing "no itching" and 10, representing "worst itch imaginable."
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.
Exclusion Criteria:
Primary non-responders to previous anti-IL-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.
Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
UAB Department of Dermatology /ID# 238563
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Medical Dermatology Specialist /ID# 238518
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2722
Country
United States
Facility Name
Arkansas Research Trials /ID# 238687
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Encino Research Center /ID# 245950
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Velocity Clinical Research, Inc. /ID# 239536
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Medderm Associates /ID# 238834
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Lakes Research, LLC /ID# 238831
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Florida International Rsrch cr /ID# 245959
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Lenus Research & Medical Group /ID# 238695
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Advanced Clinical Research Institute /ID# 238697
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607-6429
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc. /ID# 238709
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
ForCare Clinical Research /ID# 238856
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Cleaver Medical Group Dermatology - Dawsonville /ID# 246327
City
Dawsonville
State/Province
Georgia
ZIP/Postal Code
30534-6369
Country
United States
Facility Name
Marietta Dermatology Clinical Research /ID# 238679
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060-1047
Country
United States
Facility Name
Arlington Dermatology /ID# 238701
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Dawes Fretzin, LLC /ID# 238704
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Tulane University /ID# 238859
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2699
Country
United States
Facility Name
Derm Institute of West Michigan /ID# 247341
City
Caledonia
State/Province
Michigan
ZIP/Postal Code
49316-7478
Country
United States
Facility Name
Zel Skin & Laser Specialists - Edina /ID# 238714
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55424-1200
Country
United States
Facility Name
Skin Specialists, PC /ID# 238514
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Forest Hills Dermatology Group /ID# 238708
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Facility Name
Buffalo Medical Group /ID# 239068
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Darst Dermatology /ID# 238677
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Wilmington Dermatology Center /ID# 246445
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Univ Hosp Cleveland /ID# 245953
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Dermatologists of Southwest Ohio, Inc /ID# 238939
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040-4520
Country
United States
Facility Name
Oregon Dermatology and Research Center /ID# 238823
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University of Pittsburgh MC /ID# 246170
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
Clinical Partners, LLC /ID# 238620
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Clinical Research Center of the Carolinas /ID# 238827
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Health Concepts /ID# 238510
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Tennessee Clinical Research Center /ID# 238682
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215-2885
Country
United States
Facility Name
Arlington Research Center, Inc /ID# 244171
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Orion Clinical Research /ID# 238619
City
Austin
State/Province
Texas
ZIP/Postal Code
78759-4100
Country
United States
Facility Name
Bellaire Dermatology /ID# 247865
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Center for Clinical Studies - Houston (Binz) /ID# 243700
City
Houston
State/Province
Texas
ZIP/Postal Code
77004-8097
Country
United States
Facility Name
Progressive Clinical Research /ID# 238565
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Specialists of Spokane /ID# 238809
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
West Virginia Research /ID# 238517
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505-0589
Country
United States
Facility Name
Dr. Chih-ho Hong Medical Inc. /ID# 238864
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Wiseman Dermatology Research /ID# 238867
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
SimcoDerm Medical and Surgical Dermatology Center /ID# 238861
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Dr. Wei Jing Loo Medicine Prof /ID# 238865
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Lynderm Research Inc. /ID# 243199
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
K. Papp Clinical Research /ID# 239695
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Nagoya City University Hospital /ID# 239286
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Takagi Dermatology Clinic /ID# 239274
City
Obihiro-shi
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
JR Sapporo Hospital /ID# 239277
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Mie University Hospital /ID# 239275
City
Tsu-shi
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Okayama University Hospital /ID# 239285
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Kansai Medical University Hospital /ID# 239278
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Hamamatsu University Hospital /ID# 239346
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
The Jikei University Hospital /ID# 239319
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
NTT Medical Center Tokyo /ID# 239287
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Tokyo Medical University Hospital /ID# 239320
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis
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