NCT04799990

Brief Summary

Study is not recruiting and using secondary data sources only

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 23, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

March 15, 2021

Last Update Submit

December 8, 2022

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Incidence Rate of Participants With Major Adverse Cardiovascular Events (MACE)

    MACE is defined as any fatal or nonfatal myocardial infarction (MI) or stroke (including cerebral infarction, nontraumatic intracerebral hemorrhage, and nontraumatic subarachnoid hemorrhage).

    Up to approximately 10 years

Secondary Outcomes (8)

  • Incidence Rate of Participants With Serious Infections

    Up to approximately 10 years

  • Incidence Rate of Participants With Tuberculosis

    Up to approximately 10 years

  • Incidence Rate of Participants With Opportunistic Infections Excluding Tuberculosis and Herpes Zoster

    Up to approximately 10 years

  • Incidence Rate of Participants With Serious Hypersensitivity Reactions

    Up to approximately 10 years

  • Incidence Rate of Participants With Autoimmune Disease

    Up to approximately 10 years

  • +3 more secondary outcomes

Study Arms (3)

Risankizumab

Participants will receive risankizumab as prescribed by their physician.

Drug: Risankizumab

Comparator Group 1

Participants will receive biologics other than interleukin (IL)-23 antagonists as prescribed by their physician.

Biological: Comparator 1

Comparator Group 2

Participants will receive non-biologic systemic small molecules as prescribed by their physician.

Drug: Comparator 2

Interventions

RisankizumabDRUG

Subcutaneous Injection

Also known as: Skyrizi
Risankizumab
Comparator 1BIOLOGICAL

Subcutaneous or Intravenous Injection

Comparator Group 1
Comparator 2DRUG

Oral, Opthalmic, Subcutaneous or Intravenous Injection

Comparator Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study is not recruiting and using secondary data sources only

Study is not recruiting and using secondary data sources only

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 16, 2021

Study Start

June 23, 2021

Primary Completion

March 10, 2022

Study Completion

March 10, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12