Secukinumab in Active Non-segmental Vitiligo

February 7, 2023 updated by: University Hospital, Ghent

Pilot Trial to Determine the Efficacy of Secukinumab in Active Non-segmental Vitiligo

Vitiligo is an acquired autoimmune skin disorder which leads to cutaneous depigmentations. A lot of progress has been made to unravel the pathophysiology of vitiligo. Several independent studies confirmed the elevated values of IL-17 in the serum of vitiligo patients and higher IL-17 values have been linked to a higher affected body surface area and a longer disease duration. The study will be a pilot trial with secukinumab in patients with active, non-segmental vitiligo. All patients will receive the active compound (= no placebo arm) as the purpose of the study is to investigate the potential efficacy of secukinumab in vitiligo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Department of Dermatology, Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Moderate to extensive vitiligo
  2. Vitiligo patients with active vitiligo.
  3. Vitiligo on hands and/or face
  4. Fitzpatrick skin type 3-6
  5. High impact

Exclusion Criteria:

  1. Active systemic infections during the 2 weeks prior to baseline (exception: common cold) or any infection that reoccurs on a regular basis.
  2. Autoimmune diseases (except thyroid disease)
  3. Use of immunosuppressive treatments
  4. Pregnancy or breastfeeding
  5. Mycobacterium tuberculosis infection as shown by positive Mantoux and/or Quantiferon test
  6. Clinical important abnormalities in blood analysis before start
  7. Use of any other investigational drug within 4 weeks prior to baseline or within a period of 5 half-lives of the investigational drug, whichever is langer (in order to assess properly the safety of secukinumab)
  8. History of hypersensitivity to any of the studied drugs or to drugs of similar chemical classes including latex hypersensitivity
  9. Important underlying medical conditions
  10. Significant medical problems
  11. Serum creatinine level exceeding 2.0 mg/dL (176.8 pmol/L) at screening.
  12. Total white blood cell (WBC) count < 2500/pL, platelets < 100 000/pL, neutrophils < 1500/ML or hemoglobin < 8.5 g/dL, at screening.
  13. Past medical history record of, or current infection with, human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus prior to baseline.
  14. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or noninvasive malignant colon polyps that have been removed).
  15. Current severe progressive or uncontrolled disease which in the judgment of the Investigator renders the patient unsuitable for the study or puts the patiënt at increased risk (eg, myocardial infarction within 26 weeks prior to baseline).
  16. Inability or unwillingness to undergo repeated venipuncture (eg, because of poor tolerability or lack of access to veins).
  17. Any medical or psychiatric condition which, in the investigator's opinion, would preclude the patient from adhering to the protocol or completing the study per protocol.
  18. History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to baseline.
  19. Plans for administration of live vaccines during the study period or in the 6 weeks prior to baseline.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Secukinumab
Drug: Secukinumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Repigmentation (percentage of repigmentation)
Time Frame: 9 months
The efficacy of the treatment will be determined by measuring the diffference in the percentage of the affected body surface area compared to baseline. The percentage of the affected body surface area will be measured by standardized digital pictures using a validated scoring system (Vitiligo Extent Score plus; VESplus).
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stabilisation of disease (percentage of affected body surface area)
Time Frame: 9 months
The efficacy of the treatment will be determined by measuring the diffference in the percentage of the affected body surface area compared to baseline. The percentage of the affected body surface area will be measured by standardized digital pictures using a validated scoring system (Vitiligo Extent Score plus; VESplus).
9 months
Disease impact
Time Frame: 9 months
Global impact score (0-10), where the higher the score the worse the outcome
9 months
Satisfaction with treatment
Time Frame: 9 months
Global Satisfaction Score, where the higher the score the better the outcome
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016/0237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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