ClinicalTrials.gg
Enrolling by invitationNCT03254667Updated Sep 16, 2025

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

An observational study in Psoriasis, sponsored by Bausch Health Americas, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Bausch Health Americas, Inc. (part of Bausch Health Companies Inc.) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,500
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies in Psoriasis by Bausch Health Americas, Inc. — 1 open to participants now, 4 under way, none of them phase 3. Psoriasis · Bausch Health Americas, Inc..

Started
2017
the only one that year
Observational
3 of 24
1 open now
Registered
20th of 24
by date

Among the 24 studies in Psoriasis by Bausch Health Americas, Inc., this one is the only one that started in 2017, is one of 3 observational ones, and was the 20th registered.

By phase

24 studies; the count open now beside each. This study's row is marked.

Phase 38 · 0 open
Phase 26 · 0 open
Phase 14 · 0 open
Observationalthis study3 · 1 open
Phase 43 · 0 open

By the year they started

First in 2007; this study’s year is marked. 1 started in 2017.

Size and results

Median enrollment 181 across the 21 interventional studies, 394 across the 3 observational. Of the 20 that completed or were terminated, 17 (85%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 24 studies in Psoriasis by Bausch Health Americas, Inc., or all of them as a file.
02

Study 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

Read the 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

03

Conditions studied

  • Psoriasis

Browse trials for

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. The subject is unable or unwilling to provide to participate in the registry.
  2. The subject is participating or planning to participate in a clinical trial with a non-marketed or marketed 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,500 participants (estimated)
Target follow-up
8 Years
Patient registry
Yes
Biospecimen retention
None retained

Groups and cohorts

  • Brodalumad exposed

    1500 subjects exposes to brodalumab

    Biological: Brodalumab

  • Comparator Subjects

    2000 comparator subjects

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

Interventions

  • BiologicalBrodalumab

    Brodalumab

  • DrugComparator Drug (non-biologic IL-17 inhibitors)

    Comparator subjects treated with non-biologic IL-17 inhibitors

06

What researchers measure

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.

    Time frame: 8 years

07

Study locations

1 site
  • Registry
    Bridgewater, New Jersey 08807, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03254667
Responsible party
Sponsor
First posted
Aug 18, 2017
Start date
Jul 25, 2017
Primary completion
Nov 10, 2030 (estimated)
Completion
Nov 2031 (estimated)
Last update
Sep 16, 2025

Study contacts

Varsha Bhatt
study director · Bausch Health Americas, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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