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

NCT03254667 | Enrolling By Invitation DMC FDA Drug

• 1 other identifier: V01-BROA-402
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Assess the incidence of malignancy

  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

Study Arms (2)

Brodalumad exposed

1500 subjects exposes to brodalumab

Biological: Brodalumab

Comparator Subjects

2000 comparator subjects

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

Interventions

Brodalumab BIOLOGICAL

Brodalumab

Brodalumad exposed

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

Comparator subjects treated with non-biologic IL-17 inhibitors

Comparator Subjects

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Must be at least 18 years of age or older
• 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.

You may not qualify if:

• The subject is unable or unwilling to provide informed consent to participate in the registry.
• 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).
• The subject is restarting the eligible medication less than 12 months since receiving the last dose.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Registry

Bridgewater, New Jersey, 08807, United States

Location

Biospecimen

Retention: NONE RETAINED

Neutrophil count

MeSH Terms

Conditions

Psoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Varsha Bhatt

  Bausch Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 18, 2017
• Study Start: July 25, 2017
• Primary Completion (Estimated): November 10, 2030
• Study Completion (Estimated): November 1, 2031
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (1)