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

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03254667
• Collaborator: (none)
• Enrollment: 3,500
• Location: 1
• Anticipated Duration (Months): 171.2
• Patients Per Site Per Month: 20.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Biological: Brodalumab; Drug: Comparator Drug (non-biologic IL-17 inhibitors)

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 3500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jul 25, 2017
• Anticipated Primary Completion Date: Nov 10, 2030
• Anticipated Study Completion Date: Nov 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Brodalumad exposed 1500 subjects exposes to brodalumab	Biological: Brodalumab; Brodalumab
Comparator Subjects 2000 comparator subjects	Drug: Comparator Drug (non-biologic IL-17 inhibitors); Comparator subjects treated with non-biologic IL-17 inhibitors

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Registry	Bridgewater	New Jersey	United States	08807

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Anya Loncaric, Bausch Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT03254667
• Other Study ID Numbers: V01-BROA-402
• First Posted: Aug 18, 2017
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Psoriasis; Brodalumab

Study Results

No Results Posted as of Dec 15, 2021