Secukinumab in Active Non-segmental Vitiligo

NCT05676333 | Completed Phase 4 DMC

• 1 other identifier: 2016/0237
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo; Secukinumab

Keywords

Vitiligo; Secukinumab

Outcome Measures

Primary Outcomes (1)

• 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).

  9 months

Secondary Outcomes (3)

• Stabilisation of disease (percentage of affected body surface area)

  9 months

• Disease impact

  9 months

• Satisfaction with treatment

  9 months

Study Arms (1)

Secukinumab

EXPERIMENTAL

Drug: Secukinumab

Interventions

Secukinumab DRUG

Secukinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Novartis: collaborator

Study Sites (1)

Department of Dermatology, Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Vitiligo

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• van Geel Nanja, MD, PhD

  Department of Dermatology, Ghent University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: January 9, 2023
• Study Start: October 12, 2016
• Primary Completion: December 16, 2017
• Study Completion: February 22, 2019
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)