- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05676333
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
Study Type
Interventional
Enrollment (Actual)
8
Phase
- 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
-
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Oost-Vlaanderen
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Gent, Oost-Vlaanderen, Belgium, 9000
- Department of Dermatology, Ghent University Hospital
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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
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Moderate to extensive vitiligo
- Vitiligo patients with active vitiligo.
- Vitiligo on hands and/or face
- Fitzpatrick skin type 3-6
- High impact
Exclusion Criteria:
- Active systemic infections during the 2 weeks prior to baseline (exception: common cold) or any infection that reoccurs on a regular basis.
- Autoimmune diseases (except thyroid disease)
- Use of immunosuppressive treatments
- Pregnancy or breastfeeding
- Mycobacterium tuberculosis infection as shown by positive Mantoux and/or Quantiferon test
- Clinical important abnormalities in blood analysis before start
- 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)
- History of hypersensitivity to any of the studied drugs or to drugs of similar chemical classes including latex hypersensitivity
- Important underlying medical conditions
- Significant medical problems
- Serum creatinine level exceeding 2.0 mg/dL (176.8 pmol/L) at screening.
- Total white blood cell (WBC) count < 2500/pL, platelets < 100 000/pL, neutrophils < 1500/ML or hemoglobin < 8.5 g/dL, at screening.
- Past medical history record of, or current infection with, human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus prior to baseline.
- 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).
- 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).
- Inability or unwillingness to undergo repeated venipuncture (eg, because of poor tolerability or lack of access to veins).
- 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.
- History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to baseline.
- 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 |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Secukinumab
|
What is the study measuring?
Primary Outcome Measures
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
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
Collaborators
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)
October 12, 2016
Primary Completion (ACTUAL)
December 16, 2017
Study Completion (ACTUAL)
February 22, 2019
Study Registration Dates
First Submitted
October 6, 2016
First Submitted That Met QC Criteria
December 22, 2022
First Posted (ACTUAL)
January 9, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 10, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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