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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 16, 2023

Interventions

  • Drug: Cedirogant
    • Capsule, Oral
  • Drug: Placebo
    • Capsule, Oral

Arms, Groups and Cohorts

  • Experimental: Arm 1: Cedirogant
    • Participants will receive cedirogant Dose A once daily.
  • Experimental: Arm 2: Cedirogant
    • Participants will receive cedirogant Dose B once daily.
  • Experimental: Arm 3: Cedirogant
    • Participants will receive cedirogant Dose C once daily.
  • Placebo Comparator: Arm 4: Placebo
    • Participants will receive placebo once daily.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants Achieving >=75% Reduction from Baseline in Psoriasis Area Severity Index (PASI) score (PASI 75)
    • Time Frame: 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 Measures

  • Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear
    • Time Frame: 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.
  • Percentage of Participants Achieving >=50% Reduction from Baseline in PASI Score (PASI 50)
    • Time Frame: 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.
  • Percentage of Participants Achieving >=90% Reduction from Baseline in PASI Score (PASI 90)
    • Time Frame: 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.
  • Percentage of Participants Achieving 100% Reduction from Baseline in PASI Score (PASI 100)
    • Time Frame: 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.
  • Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 for Participants with PSS >0 at Baseline
    • Time Frame: 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).
  • Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) >=4-Point Improvement from Baseline for Participants with Itch NRS >=4 at Baseline
    • Time Frame: 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.”

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AbbVie
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • ABBVIE INC., Study Director, AbbVie
  • Overall Contact(s)
    • ABBVIE CALL CENTER, 844-663-3742, abbvieclinicaltrials@abbvie.com

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