Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT05676333
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05676333
Study Brief:
Protocol Section:
NCT05676333