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

Bausch Health

Status: Invitation-only

Conditions: Psoriasis

Treatments: Drug: Comparator Drug (non-biologic IL-17 inhibitors); Biological: Brodalumab

Study type: Observational

Funder types: Industry

Identifiers

NCT03254667

V01-BROA-402

Details and patient eligibility

About

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

Full 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

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,500 participants in 2 patient groups

Brodalumad exposed

Description:

1500 subjects exposes to brodalumab

Treatment:

Biological: Brodalumab

Comparator Subjects

Description:

2000 comparator subjects

Treatment:

Drug: Comparator Drug (non-biologic IL-17 inhibitors)