VitiligoPhase 4NCT05676333
Secukinumab in Active Non-segmental Vitiligo
A Phase 4 study testing Secukinumab in people with Vitiligo and Secukinumab, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo, Secukinumab
- What is being tested?
- Secukinumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Oct 2016to 22 Feb 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to extensive vitiligo
- Vitiligo patients with active vitiligo.
- Vitiligo on hands and/or face
- Fitzpatrick skin type 3-6
- High impact
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Dermatology, Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: 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.
- Conditions
- Vitiligo, Secukinumab
- Being tested
- Secukinumab
- Keywords
- Vitiligo, Secukinumab
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Experimental | Not described Receives: Drug: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 9 months
Secondary outcomes (3)
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).
Measured: 9 months
Disease impact
Global impact score (0-10), where the higher the score the worse the outcome
Measured: 9 months
Satisfaction with treatment
Global Satisfaction Score, where the higher the score the better the outcome
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start12 Oct 2016
- Primary completion16 Dec 2017
- Study completion22 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- van Geel Nanja, MD, PhD, Principal investigator, Department of Dermatology, Ghent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676333
- Sponsor's protocol ID
- 2016/0237
- Status last verified
- Feb 2023
- First submitted
- 6 Oct 2016
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial to Determine the Efficacy of Secukinumab in Active Non-segmental Vitiligo
- ClinicalTrials.gov ID
- NCT05676333
- Acronym / sponsor ID
- 2016/0237
- Conditions
- Vitiligo, Secukinumab
- Keywords
- Vitiligo, Secukinumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 16 Dec 2017 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | Experimental | Drug: Secukinumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Moderate to extensive vitiligo
- Vitiligo patients with active vitiligo.
- Vitiligo on hands and/or face
- Fitzpatrick skin type 3-6
- High impact
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secukinumab | Drug | Secukinumab |
Primary outcome
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).
3 secondary outcomes
Stabilisation of disease (percentage of affected body surface area)
Time frame: 9 months
Disease impact
Time frame: 9 months
Satisfaction with treatment
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
van Geel Nanja, MD, PhD principal investigator
Department of Dermatology, Ghent University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Secukinumab in people with Vitiligo and Secukinumab, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repigmentation (percentage of repigmentation) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.