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

NCT ID: NCT03254667

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-25

Study Completion Date

2031-11-30

Brief Summary

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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

Detailed Description

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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

Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Brodalumad exposed

1500 subjects exposes to brodalumab

Brodalumab

Intervention Type BIOLOGICAL

Brodalumab

Comparator Subjects

2000 comparator subjects

Comparator Drug (non-biologic IL-17 inhibitors)

Intervention Type DRUG

Comparator subjects treated with non-biologic IL-17 inhibitors

Interventions

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Brodalumab

Brodalumab

Intervention Type BIOLOGICAL

Comparator Drug (non-biologic IL-17 inhibitors)

Comparator subjects treated with non-biologic IL-17 inhibitors

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Varsha Bhatt

Role: STUDY_DIRECTOR

Bausch Health

Locations

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Registry

Bridgewater, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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V01-BROA-402

Identifier Type: -

Identifier Source: org_study_id

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