Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03254667
Recruitment Status : Not yet recruiting
First Posted : August 18, 2017
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

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
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

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Years
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
Estimated Study Start Date : September 15, 2018
Estimated Primary Completion Date : November 10, 2030
Estimated Study Completion Date : November 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Brodalumab

Group/Cohort 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




Primary Outcome Measures :
  1. Assess the incidence of malignancy [ Time Frame: 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.


Biospecimen Retention:   None Retained
Neutrophil count


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254667


Contacts
Layout table for location contacts
Contact: Lindsey Mathew 9085413279 lindsey.mathew@valeant.com

Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Layout table for investigator information
Study Director: Lindsey Mathew Valeant Pharmaceuticals

Additional Information:

Layout table for additonal information
Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT03254667     History of Changes
Other Study ID Numbers: V01-BROA-402
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Brodalumab
Antibodies, Monoclonal
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs