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Secukinumab in Active Non-segmental Vitiligo

Primary Purpose

Vitiligo, Secukinumab

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Secukinumab
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, Secukinumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Dermatology, Ghent University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Secukinumab

Arm Description

Outcomes

Primary Outcome Measures

Repigmentation (percentage of repigmentation)
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).

Secondary Outcome Measures

Stabilisation of disease (percentage of affected body surface area)
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).
Disease impact
Global impact score (0-10), where the higher the score the worse the outcome
Satisfaction with treatment
Global Satisfaction Score, where the higher the score the better the outcome

Full Information

First Posted
October 6, 2016
Last Updated
February 7, 2023
Sponsor
University Hospital, Ghent
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT05676333
Brief Title
Secukinumab in Active Non-segmental Vitiligo
Official Title
Pilot Trial to Determine the Efficacy of Secukinumab in Active Non-segmental Vitiligo
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2016 (Actual)
Primary Completion Date
December 16, 2017 (Actual)
Study Completion Date
February 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo, Secukinumab
Keywords
Vitiligo, Secukinumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Secukinumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Primary Outcome Measure Information:
Title
Repigmentation (percentage of repigmentation)
Description
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).
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Stabilisation of disease (percentage of affected body surface area)
Description
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).
Time Frame
9 months
Title
Disease impact
Description
Global impact score (0-10), where the higher the score the worse the outcome
Time Frame
9 months
Title
Satisfaction with treatment
Description
Global Satisfaction Score, where the higher the score the better the outcome
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
van Geel Nanja, MD, PhD
Organizational Affiliation
Department of Dermatology, Ghent University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Ghent University Hospital
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Secukinumab in Active Non-segmental Vitiligo

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