Secukinumab in Active Non-segmental Vitiligo

NCT ID: NCT05676333

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-12
• Study Completion Date: 2019-02-22

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Secukinumab

Group Type: EXPERIMENTAL

Secukinumab

Intervention Type: DRUG

Interventions

Secukinumab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Moderate to extensive vitiligo

2. Vitiligo patients with active vitiligo.

3. Vitiligo on hands and/or face

4. Fitzpatrick skin type 3-6

5. High impact

Exclusion Criteria

1. Active systemic infections during the 2 weeks prior to baseline (exception: common cold) or any infection that reoccurs on a regular basis.

2. Autoimmune diseases (except thyroid disease)

3. Use of immunosuppressive treatments

4. Pregnancy or breastfeeding

5. Mycobacterium tuberculosis infection as shown by positive Mantoux and/or Quantiferon test

6. Clinical important abnormalities in blood analysis before start

7. 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)

8. History of hypersensitivity to any of the studied drugs or to drugs of similar chemical classes including latex hypersensitivity

9. Important underlying medical conditions

10. Significant medical problems

11. Serum creatinine level exceeding 2.0 mg/dL (176.8 pmol/L) at screening.

12. Total white blood cell (WBC) count < 2500/pL, platelets < 100 000/pL, neutrophils < 1500/ML or hemoglobin < 8.5 g/dL, at screening.

13. Past medical history record of, or current infection with, human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus prior to baseline.

14. 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).

15. 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).

16. Inability or unwillingness to undergo repeated venipuncture (eg, because of poor tolerability or lack of access to veins).

17. 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.

18. History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to baseline.

19. Plans for administration of live vaccines during the study period or in the 6 weeks prior to baseline.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

van Geel Nanja, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Ghent University Hospital

Locations

Department of Dermatology, Ghent University Hospital

Ghent, Oost-Vlaanderen, Belgium

Countries

Belgium

Other Identifiers

2016/0237

Identifier Type: -

Identifier Source: org_study_id