Vitiligo
Conditions
Interventions
Trade Name: Cosentyx®
Product Name: Cosentyx®
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
CAS Number: 1229022-83-6
Other descriptive name: SECUKI
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Moderate to extensive vitiligo (body surface area = 3%) 2) Vitiligo patients with ‘active vitiligo’. Active vitiligo will be defined as: - clear evidence of progression using digital pictures for follow-up (maximum time between the two observations = 7 months) and/or - disease progression during the last six months (as reported by the patient) or at least one clinical activity sign (hypopigmented areas, vitiligo lesions with blurred borders or confetti-like depigmentations) 3) Vitiligo on hands and/or face 4) Fitzpatrick skin type 3-6 5) Impact score > 8/10 or DLQI (Dermatology Life Quality Index) > 10 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
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 (such as leukopenia, liver or kidney abnormalities) 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 longer (in order to assess properly the safety of secukinumab) 8) History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes including latex hypersensitivity 9) Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy. 10) Significant medical problems, including but not limited to the following: uncontrolled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 95 mmHg), congestive heart failure (New York Heart Association [NYHA] status of class III or IV). 11) Serum creatinine level exceeding 2.0 mg/dL (176.8 µmol/L) at screening. 12) Total white blood cell (WBC) count < 2500/µL, platelets < 100 000/µL, neutrophils < 1500/µL 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 non-invasive 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 patient 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will be: 2. Disease stability (stop of progression) 3. Improvement in Dermatology Life Quality Index (DLQI) or Global Impact Score 4. Improvement in Global Satisfaction Score using the Likert scale (5 points) ;Timepoint(s) of evaluation of this end point: up until 9 months after first dose | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate the capacity of a targeted anti-IL-17A treatment with secukinumab to induce repigmentation in vitiligo patients with active disease.;Secondary Objective: The secondary objective of this study is to determine if the disease can be stabilized and if the quality of life and the impact of the disease on the daily life of the patients can be improved by this treatment.;Primary end point(s): The primary endpoint is to investigate if secukinumab is effective in active vitiligo. The primary endpoint will be: 1. Percentage of repigmentation ;Timepoint(s) of evaluation of this end point: up until 9 months after first dose | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed