LTS of Siliq vs. Other Therapies Treating of Adults With... | NCT03254667

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

NCT03254667

Sponsor

Bausch Health Americas, Inc.

Status

Enrolling by invitation

Last Update Posted

Sep 16, 2025Actual

Enrollment

3,500Estimated

Phase

Not provided

Conditions

Psoriasis

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2017Actual

Primary Completion Date

Nov 10, 2030Estimated

Completion Date

Nov 2031Estimated

First Submitted Date

Aug 15, 2017

First Submission Date that Met QC Criteria

Aug 17, 2017

First Posted Date

Aug 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2025

Last Update Posted Date

Sep 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

8 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brodalumad exposed		1500 subjects exposes to brodalumab	Biological: Brodalumab
Comparator Subjects		2000 comparator subjects	Drug: Comparator Drug (non-biologic IL-17 inhibitors)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brodalumab	Biological	Brodalumab	Brodalumad exposed
Comparator Drug (non-biologic IL-17 inhibitors)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis and main criteria for inclusion: a subject must have moderate to severe psoriasis diagnosed by a dermatologist
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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Varsha Bhatt	Bausch Health Americas, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Registry		Bridgewater	New Jersey	08807	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided