LTS of Siliq vs. Other Therapies Treating of Adults With Moderate-to-Severe Psoriasis

February 22, 2024 updated by: Bausch Health Americas, Inc.

Prospective, Observational Study Brodalumab Compared With Other Therapies in the Treatment of Adults With Moderate-to-Severe Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care

Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care

Study Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Registry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Study population consisting of 1500 subjects treated with Brodalumab, and 2000 comparator subjects being treated with a non-biologic IL-17 inhibitor drug.

Description

Inclusion Criteria:

  1. Diagnosis and main criteria for inclusion: a subject must have moderate to severe psoriasis diagnosed by a dermatologist
  2. Must be at least 18 years of age or older
  3. Started on or switched to a systemic psoriasis treatment within the previous 12 months. FDA-approved biologic treatments and select non-biologic treatments (eg, methotrexate, cyclosporine, or apremilast only) are permitted.

Exclusion Criteria:

  1. The subject is unable or unwilling to provide informed consent to participate in the registry.
  2. The subject is participating or planning to participate in a clinical trial with a non-marketed or marketed investigational drug (i.e. Phase I-IV drug trial).
  3. The subject is restarting the eligible medication less than 12 months since receiving the last dose.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Brodalumad exposed
1500 subjects exposes to brodalumab
Biological: Brodalumab
Brodalumab
Comparator Subjects
2000 comparator subjects
Drug: Comparator Drug (non-biologic IL-17 inhibitors)
Comparator subjects treated with non-biologic IL-17 inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the incidence of malignancy
Time Frame: 8 years
Assess the incidence of malignancy, excluding non-melanoma skin cancer (NMSC), in adult psoriasis subjects exposed to brodalumab in the course of actual clinical care compared to non-IL-17-inhibitor biologic medications used to treat psoriasis.
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Investigators

  • Study Director: Anya Loncaric, Bausch Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2017

Primary Completion (Estimated)

November 10, 2030

Study Completion (Estimated)

November 1, 2031

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 18, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V01-BROA-402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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