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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03254667
• Other study ID #: V01-BROA-402
• Status: Enrolling by invitation
• Start date: July 25, 2017
• Est. completion date: November 2031

Study information

• Verified date: February 2024
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3500
• Est. completion date: November 2031
• Est. primary completion date: November 10, 2030
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Brodalumab
Brodalumab

Drug:
• Comparator Drug (non-biologic IL-17 inhibitors)
Comparator subjects treated with non-biologic IL-17 inhibitors

Locations

Country	Name	City	State
United States	Registry	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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