This study is to evaluate how different doses of AS012 act in vitiligo patients when compared with placebo.
Scientific Title of Study
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
Ajanta Research Centre, Ajanta Hospital and IVF Centre
Ajanta Research Centre, Ajanta Hospital and IVF Centre, 765, ABC Complex, Kanpur Road, Alambagh, , Lucknow-226005 Lucknow UTTAR PRADESH
9838001239
amitmadan2000@yahoo.com
Dr Manish Jain
Ananta Institute of Medical Sciences and Research Centre
Room No. 11, First Floor, Dept. of Dermatology, Venerology, Leprosy, Ananta Institute of Medical Sciences and Research Centre, NH 8, Village- Kaliwas, Teh. Nathdwara, Dist. Rajsamand-313202 Rajsamand RAJASTHAN
8875166990
dr.mj.06@gmail.com
Dr Bela Shah
B.J. Medical College and Civil Hospital
Room no. 139, wing 3, Dept. of Dermatology,1st floor, OPD Building, B.J. Medical College and Civil Hospital Asarwa, Ahmedabad-380016 Ahmadabad GUJARAT
Dept. of Dermatology, Room No. 05, College of Medicine & Sagore Dutta Hospital, 578 B.T. Road, Kamarhati, Kolkata-700058, West Bengal Kolkata WEST BENGAL
919007977161
Ipodder88@gmail.com
Dr Sudhir Medhekar
Government Medical College and Hospital
Government Medical College and Hospital, Near Panchakki Road, Aurangabad-431001 Aurangabad MAHARASHTRA
919820321430
sudhir.medhekar@gmail.com
Dr Saurabh Kapadia
Kanoria Hospital and Research Centre
Room No. 01, Ground Floor, Dermatology Department, Kanoria Hospital and Research Centre, Airport-Gandhinagar Highway, Village-Bhat, Dist. Gandhinagar-382428 Gandhinagar GUJARAT
917923969274
kanoriahospital@yahoo.com
Dr Nandini A S
KIMS Hospital
Dept. of Dermatology,B Block, 2nd floor, Room No. 10, KIMS Hospital, KR Road, V V Puram, Bangalore-560004, Karnataka Bangalore KARNATAKA
919886829579
drnandinias2002@yahoo.com
Dr Bangaru H
KR Hospital attached to Mysore Medical College and Research Institute
Room No. 12, Dept. of Dermatology, KR Hospital attached to Mysore Medical College and Research Institute, Irwin Road, Mysuru-570001, Karnataka Mysore KARNATAKA
919886789231
drbangaruskin@gmail.com
Dr Parag Kalyani
Noble Hospital Pvt. Ltd.
OPD No. 17, Noble Hospital Pvt. Ltd, 153, Magarpatta city road, Hadapsar, Pune, 411013 Pune MAHARASHTRA
919130603303
parag.kalyani@yahoo.com
Dr Sarita Tippannawar
Oyester & Pearl Hospital, Maharashtra
Oyester & Pearl Hospitals(Phadnis Clinic Pvt Ltd) 16781-75, Ganeshkhind Road, Shivajinagar, Pune-411005 Pune MAHARASHTRA
9370665436
drsarita1234@gmail.com
Dr Davinder Parsad
PGIMER
Room No. 06, 2nd floor, D Block, Dept. of Dermatology, Nehru Hospital, Post Graduate Institute of Medicine and Research, Sector-12, Chandigarh-160012 Chandigarh CHANDIGARH
919876060361
parsadd@yahoo.com
Dr Hari Kishan
Rajarajeshwari Medical College and Hospital
Dept. of Dermatology, RajaRajeswari Medical College and Hospital, No.202, Kambipura, Mysore Road
Bengaluru,560074, Karnataka Bangalore KARNATAKA
919902066568
drharikishankumar@gmail.com
Dr Chetan Lalseta
Shree Giriraj Multispeciality Hospital, Gujarat
Shree Giriraj Multispeciality Hospital, 150 feet Ring road,27, Navjyot Park Main Road, Rajkot-360005, Gujarat, India Rajkot GUJARAT
9825199585
chetanlalseta@gmail.com
Dr Sunil Vartak
Sujata Birla Hospital and Medical Research Center, Maharashtra
Sujata Birla Hospital and Medical Research Center, Opp. Bytco College, Nashik Pune Highway, Nashik Road, Nashik-422101, Maharashtra, India Nashik MAHARASHTRA
9373901829
suneel.vartak@gmail.com
Dr Swetha
Vijaya Super Speciality Hospital, Andhra Pradesh
Vijaya Super Speciality Hospital, Bright Skin Hair & Laser Center, A unit of Vijaya Super Speciality Hospital, Ground Floor, OPD Room no. 04, Pogathota Raghava Cine Complex Road, Nellore-524001, Andhra pradesh, India Nellore ANDHRA PRADESH
Vijaya Ethics Committee, Vijaya Super Speciality Hospital, Andhra Pradesh
Approved
Yash Societys Sujata Birla Ethics Committee, Sujata Birla Hospital and Medical Research Center, Maharashtra
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L80||Vitiligo,
Intervention / Comparator Agent
Type
Name
Details
Intervention
AS012-20-01 dose I Regime 1
2. Dose: AS012-20-01 dose I Regimen 1,
Route of administration: Oral
Frequency of administration: regimen 1
Intervention
AS012-20-01 dose II Regime 1
3. Dose : AS012-20-01 dose II regimen 1
Route of administration: Oral
Frequency of administration: regimen 1
Intervention
AS012-20-01 dose III Regime 1
4. Dose: AS012-20-01 dose III regimen 1
Route of administration: Oral
Frequency of administration: regimen 1
Intervention
AS012-20-01 dose IV Regime 2
5. Dose: AS012-20-01 dose IV regimen 2
Route of administration: Oral
Frequency of administration: regimen 2
Comparator Agent
Placebo
1. Dose: Placebo Tablets of AS012
Route of administration: Oral
Frequency of administration: regimen 1/Regimen 2
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Mean change, from baseline, in VASI score
Baseline and week 24
Secondary Outcome
Outcome
TimePoints
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
Target Sample Size
Total Sample Size="320" Sample Size from India="128" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Sun Pharma Global FZE is developing a medication
called AS012 . The objective of this study is to evaluate
how different doses of AS012 act in non-segmental vitiligo patients when
compared with
followed by 12 weeks of safety follow-up . The investigators will assess enrolled
subject’s clinical progress with the help of validated questionnaires. Also,
subjects will document their perception about clinical progress
with the help
of self-administered questionnaires.Responses received from investigators and subjects at various timepoints
in the study will be compared with the responses documented at baseline visit.