CTRI/2021/01/030627进行中（未招募）2 期
A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AS012 IN SUBJECTS WITH NON-SEGMENTAL VITILIGO
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
- 试验地点
- 16
- 主要终点
- Mean change, from baseline, in VASI score
研究概览
简要总结
Sun Pharma Global FZE is developing a medicationcalled AS012 .The objective of this study is to evaluatehow different doses of AS012 act in non-segmental vitiligo patients whencompared with
Placebo. Approximately, 320 subjects will beenrolled in the study in to five different treatment groups viz. Placebo Tabletsof AS012, AS012 (AS012-20-01 dose I regimen 1), AS012 (AS012 dose II regimen 1), AS012
(AS012-20-01 dose IIIregimen 1) and AS012 (AS012-20-01 dose IV regimen 2). The duration of each subject’sparticipation in the study will be approximately 64 weeks (449 days), with 52weeks of the study treatment
followed by 12 weeks of safety follow-up . The investigators will assess enrolledsubject’s clinical progress with the help of validated questionnaires. Also,subjects will document their perception about clinical progress
with the helpof self-administered questionnaires. Responses received from investigators and subjects at various timepointsin the study will be compared with the responses documented at baseline visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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), Implanonâ„¢ (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.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.
排除标准
- •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.
结局指标
主要结局
Mean change, from baseline, in VASI score
时间窗: Baseline and week 24
次要结局
- Mean change, from baseline, in VES.(Baseline & Week 24.)
- Mean change, from baseline, in VES for face(Baseline & Week 24)
- Mean change, from baseline, in SA-VES(Baseline & Week 24)
- Mean change, from baseline, in VIPs(Baseline & Week 24)
研究者
研究点 (16)
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