Secukinumab in Active Non-segmental Vitiligo
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Secukinumab
|
Drug: Secukinumab
|
Outcome Measures
Primary Outcome Measures
- Repigmentation (percentage of repigmentation) [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).
Secondary Outcome Measures
- Stabilisation of disease (percentage of affected body surface area) [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).
- Disease impact [9 months]
Global impact score (0-10)
- Satisfaction with treatment [9 months]
Global Satisfaction Score
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Moderate to extensive vitiligo
-
Vitiligo patients with active vitiligo.
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Vitiligo on hands and/or face
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Fitzpatrick skin type 3-6
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High impact
Exclusion Criteria:
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Active systemic infections during the 2 weeks prior to baseline (exception: common cold) or any infection that reoccurs on a regular basis.
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Autoimmune diseases (except thyroid disease)
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Use of immunosuppressive treatments
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Pregnancy or breastfeeding
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Mycobacterium tuberculosis infection as shown by positive Mantoux and/or Quantiferon test
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Clinical important abnormalities in blood analysis before start
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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)
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History of hypersensitivity to any of the studied drugs or to drugs of similar chemical classes including latex hypersensitivity
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Important underlying medical conditions
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Significant medical problems
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Serum creatinine level exceeding 2.0 mg/dL (176.8 pmol/L) at screening.
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Total white blood cell (WBC) count < 2500/pL, platelets < 100 000/pL, neutrophils < 1500/ML or hemoglobin < 8.5 g/dL, at screening.
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Past medical history record of, or current infection with, human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus prior to baseline.
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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).
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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).
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Inability or unwillingness to undergo repeated venipuncture (eg, because of poor tolerability or lack of access to veins).
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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.
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History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to baseline.
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Plans for administration of live vaccines during the study period or in the 6 weeks prior to baseline.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Dermatology, Ghent University Hospital | Gent | Oost-Vlaanderen | Belgium | 9000 |
Sponsors and Collaborators
- University Hospital, Ghent
- Novartis
Investigators
- Principal Investigator: van Geel Nanja, MD, PhD, Department of Dermatology, Ghent University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016/0237