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A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05044234
Collaborator
(none)
200
Enrollment
55
Locations
4
Arms
16
Anticipated Duration (Months)
3.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 16, 2021
Anticipated Primary Completion Date :
Feb 16, 2023
Anticipated Study Completion Date :
Mar 18, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: Cedirogant

Participants will receive cedirogant Dose A once daily.

Drug: Cedirogant
Capsule, Oral
Other Names:
  • ABBV-157

    		•
    Experimental: Arm 2: Cedirogant

    Participants will receive cedirogant Dose B once daily.

    Drug: Cedirogant
    Capsule, Oral
    Other Names:
  • ABBV-157

    		•
    Experimental: Arm 3: Cedirogant

    Participants will receive cedirogant Dose C once daily.

    Drug: Cedirogant
    Capsule, Oral
    Other Names:
  • ABBV-157

    		•
    Placebo Comparator: Arm 4: Placebo

    Participants will receive placebo once daily.

    Drug: Placebo
    Capsule, Oral

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving >=75% Reduction from Baseline in Psoriasis Area Severity Index (PASI) score (PASI 75) [Week 16]

      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

    1. Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear [Week 16]

      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.

    2. Percentage of Participants Achieving >=50% Reduction from Baseline in PASI Score (PASI 50) [Week 16]

      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.

    3. Percentage of Participants Achieving >=90% Reduction from Baseline in PASI Score (PASI 90) [Week 16]

      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.

    4. Percentage of Participants Achieving 100% Reduction from Baseline in PASI Score (PASI 100) [Week 16]

      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.

    5. Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 for Participants with PSS >0 at Baseline [Week 16]

      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).

    6. Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) >=4-Point Improvement from Baseline for Participants with Itch NRS >=4 at Baseline [Week 16]

      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."

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UAB Department of Dermatology /ID# 238563 Birmingham Alabama United States 35233
    2 Medical Dermatology Specialist /ID# 238518 Phoenix Arizona United States 85006-2722
    3 Arkansas Research Trials /ID# 238687 North Little Rock Arkansas United States 72117
    4 Encino Research Center /ID# 245950 Encino California United States 91436
    5 Velocity Clinical Research, Inc. /ID# 239536 North Hollywood California United States 91606
    6 Medderm Associates /ID# 238834 San Diego California United States 92103
    7 Lakes Research, LLC /ID# 238831 Miami Florida United States 33014
    8 Florida International Rsrch cr /ID# 245959 Miami Florida United States 33173
    9 Lenus Research & Medical Group /ID# 238695 Sweetwater Florida United States 33172
    10 Advanced Clinical Research Institute /ID# 238697 Tampa Florida United States 33607-6429
    11 Clinical Research Trials of Florida, Inc. /ID# 238709 Tampa Florida United States 33607
    12 ForCare Clinical Research /ID# 238856 Tampa Florida United States 33613-1244
    13 Cleaver Medical Group Dermatology - Dawsonville /ID# 246327 Dawsonville Georgia United States 30534-6369
    14 Marietta Dermatology Clinical Research /ID# 238679 Marietta Georgia United States 30060-1047
    15 Arlington Dermatology /ID# 238701 Rolling Meadows Illinois United States 60008
    16 Dawes Fretzin, LLC /ID# 238704 Indianapolis Indiana United States 46256
    17 Tulane University /ID# 238859 New Orleans Louisiana United States 70112-2699
    18 Derm Institute of West Michigan /ID# 247341 Caledonia Michigan United States 49316-7478
    19 Zel Skin & Laser Specialists - Edina /ID# 238714 Edina Minnesota United States 55424-1200
    20 Skin Specialists, PC /ID# 238514 Omaha Nebraska United States 68144
    21 Forest Hills Dermatology Group /ID# 238708 Kew Gardens New York United States 11415
    22 Buffalo Medical Group /ID# 239068 Williamsville New York United States 14221
    23 Darst Dermatology /ID# 238677 Charlotte North Carolina United States 28277
    24 Wilmington Dermatology Center /ID# 246445 Wilmington North Carolina United States 28403
    25 Univ Hosp Cleveland /ID# 245953 Cleveland Ohio United States 44106
    26 Dermatologists of Southwest Ohio, Inc /ID# 238939 Mason Ohio United States 45040-4520
    27 Oregon Dermatology and Research Center /ID# 238823 Portland Oregon United States 97210
    28 University of Pittsburgh MC /ID# 246170 Pittsburgh Pennsylvania United States 15260
    29 Clinical Partners, LLC /ID# 238620 Johnston Rhode Island United States 02919
    30 Clinical Research Center of the Carolinas /ID# 238827 Charleston South Carolina United States 29407
    31 Health Concepts /ID# 238510 Rapid City South Dakota United States 57702
    32 Tennessee Clinical Research Center /ID# 238682 Nashville Tennessee United States 37215-2885
    33 Arlington Research Center, Inc /ID# 244171 Arlington Texas United States 76011
    34 Orion Clinical Research /ID# 238619 Austin Texas United States 78759-4100
    35 Bellaire Dermatology /ID# 247865 Bellaire Texas United States 77401
    36 Center for Clinical Studies - Houston (Binz) /ID# 243700 Houston Texas United States 77004-8097
    37 Progressive Clinical Research /ID# 238565 San Antonio Texas United States 78229
    38 Dermatology Specialists of Spokane /ID# 238809 Spokane Washington United States 99202
    39 West Virginia Research /ID# 238517 Morgantown West Virginia United States 26505-0589
    40 Dr. Chih-ho Hong Medical Inc. /ID# 238864 Surrey British Columbia Canada V3R 6A7
    41 Wiseman Dermatology Research /ID# 238867 Winnipeg Manitoba Canada R3M 3Z4
    42 SimcoDerm Medical and Surgical Dermatology Center /ID# 238861 Barrie Ontario Canada L4M 7G1
    43 Dr. Wei Jing Loo Medicine Prof /ID# 238865 London Ontario Canada N6H 5L5
    44 Lynderm Research Inc. /ID# 243199 Markham Ontario Canada L3P 1X2
    45 K. Papp Clinical Research /ID# 239695 Waterloo Ontario Canada N2J 1C4
    46 Nagoya City University Hospital /ID# 239286 Nagoya shi Aichi Japan 467-8602
    47 Takagi Dermatology Clinic /ID# 239274 Obihiro-shi Hokkaido Japan 080-0013
    48 JR Sapporo Hospital /ID# 239277 Sapporo-shi Hokkaido Japan 060-0033
    49 Mie University Hospital /ID# 239275 Tsu-shi Mie Japan 514-8507
    50 Okayama University Hospital /ID# 239285 Okayama-shi Okayama Japan 700-8558
    51 Kansai Medical University Hospital /ID# 239278 Hirakata-shi Osaka Japan 573-1191
    52 Hamamatsu University Hospital /ID# 239346 Hamamatsu-shi Shizuoka Japan 431-3192
    53 The Jikei University Hospital /ID# 239319 Minato-ku Tokyo Japan 105-8471
    54 NTT Medical Center Tokyo /ID# 239287 Shinagawa-ku Tokyo Japan 141-8625
    55 Tokyo Medical University Hospital /ID# 239320 Shinjuku-ku Tokyo Japan 160-0023

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05044234
    Other Study ID Numbers:
    • M18-816
    First Posted:
    Sep 14, 2021
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AbbVie
    Psoriasis
    Plaque Psoriasis
    Cedirogant
    ABBV-157
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of Aug 8, 2022