This study is to evaluate how different doses of AS012 act in vitiligo patients when compared with placebo.
- Conditions
- Health Condition 1: L80- Vitiligo
- Registration Number
- CTRI/2021/01/030627
- Lead Sponsor
- Sun Pharma Global FZE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Males and non-pregnant non-lactating females > 18 years of age providing written informed consent prior to any study-related procedures
2.Diagnosis of generalized, non-segmental vitiligo confirmed by physical examination by investigator
3.Female Subjects of childbearing potential (excluding women who arepremenarchal, surgically sterilized (by hysterectomy) or postmenopausal for atleast 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the dayof the first dose administration to 90 days after the last administration of study drug. For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptivepatches, Depo-Provera® (stabilized for at least 3 months), NuvaRing® (vaginal contraceptive), Implanon™ (contraceptive implant), double barrier methods (e.g. condom and spermicide), intrauterine device (IUD), tubal ligation, Essure or abstinence with a 2nd acceptable method of birth control should the Subject become sexually active. Subjects on hormonal contraception must be stabilized on the same type for at least three months prior to enrolment in the study and must not change the method during the study. A sterile sexual partner is NOT considered an adequate form of birth control.
4.All male Subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 90 days after the last administration of study drug. Abstinence is an acceptable method of birth control. Female partners should use an acceptable method of birth control as described in the above Item Number 5.
5.Willing to refrain from using all study prohibited medications during the treatment period
6.Willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
1.Female Subjects who are pregnant, nursing or planning to become pregnant during study participation or within 3 months of completing the study
2.Segmental vitiligo, focal, or mixed vitiligo
3.Subjects who have high risk of suicidality at the Screening and Baseline assessments based on Investigator’s judgment or, if appropriate, as indicated by a response of yes ? within the last 12 months to Questions 4 or 5 in the suicidal ideation section, or any positive response in the behavioral section of the Columbia Suicide Severity Rating Scale (C-SSRS)
4.Planned surgical intervention between baseline and the Week 52 evaluation for a pre-treatment condition unless they are considered a minor surgery by the Investigator, such as tooth, cyst, or skin tag extraction
5.Any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator precludes the subject’s participation in the study or interferes with the interpretation of the study results.
6.Serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus, unless they are considered patients with resolved Hepatitis B and C infections (i.e. HBc IgG Ab+/HbsAg -/HBV DNA-, HepC Ab+/HCV RNA-)
7.History of alcohol or drug abuse in the previous 2 years
8.Consumption of excessive amounts of alcohol (greater than 2 drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates)
9.Participation in an investigational drug study (i.e., Subjects have been treated with an investigational drug) within 30 days prior to screening. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion
10.Presence of excessive hair, tattoos, pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment area, which could make the affected vitiligo BSA difficult to visualize
11.Previous enrolment in this study
12.The subject or a family member is among the personnel of the investigational site or Sponsor designee staff directly involved with this trial.
13.Subjects who are members of the same household with subjects participating or previously enrolled in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change, from baseline, in VASI scoreTimepoint: Baseline and week 24
- Secondary Outcome Measures
Name Time Method Mean change, from baseline, in SA-VESTimepoint: Baseline & Week 24;Mean change, from baseline, in VES for faceTimepoint: Baseline & Week 24;Mean change, from baseline, in VES.Timepoint: Baseline & Week 24.;Mean change, from baseline, in VIPsTimepoint: Baseline & Week 24