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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05044234
Recruitment Status : Terminated (Company Decision)
First Posted : September 14, 2021
Last Update Posted : December 22, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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
Psoriasis Drug: Cedirogant Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 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 : November 16, 2021
Actual Primary Completion Date : November 30, 2022
Actual Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: Cedirogant
Participants will receive cedirogant Dose A once daily.
 Drug: Cedirogant
Capsule, Oral
Other Name: ABBV-157
Experimental: Arm 2: Cedirogant
Participants will receive cedirogant Dose B once daily.
 Drug: Cedirogant
Capsule, Oral
Other Name: ABBV-157
Experimental: Arm 3: Cedirogant
Participants will receive cedirogant Dose C once daily.
 Drug: Cedirogant
Capsule, Oral
Other Name: ABBV-157
Placebo Comparator: Arm 4: Placebo
Participants will receive placebo once daily.
 Drug: Placebo
Capsule, Oral


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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."


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05044234


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05044234    
Other Study ID Numbers: M18-816
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
URL: https://vivli.org/ourmember/abbvie/

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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:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases