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

• Conditions: Psoriasis
• Interventions: Biological: Brodalumab; Drug: Comparator Drug (non-biologic IL-17 inhibitors)

• Registration Number: NCT03254667
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2017-07-25
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2030-11-10
• Study Completion: 2031-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 3500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brodalumad exposed	Brodalumab	1500 subjects exposes to brodalumab
Comparator Subjects	Comparator Drug (non-biologic IL-17 inhibitors)	2000 comparator subjects

Primary Outcome Measures

Name	Time	Method
Assess the incidence of malignancy	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.

Trial Locations

Locations (1)

Registry; 🇺🇸 Bridgewater, New Jersey, United States