CTRI/2025/10/095999 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On:
17/06/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A clinical trial to evaluate safety and efficacy of AB1001 topical gel in vitiligo patients.
Scientific Title of Study
A Phase II, multicenter, randomized study to evaluate safety and efficacy of topical AB1001 in adult patients with non-segmental vitiligo.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
AHA-AB1001-001 Version 1.0 Dated 11-December-2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Davinder Parsad
Designation
HOD- DERMATOLOGY
Affiliation
PGIMER, Chandigarh
Address
Department of Dermatology, Sector 12, Chandigarh -India
Chandigarh CHANDIGARH 160012 India
Phone
9914209560
Fax
Email
prasad.davinder@pgimer.edu.in
Details of Contact Person Scientific Query
Name
Dr Parul Ganju
Designation
Co-founder, CEO
Affiliation
Ahammune Biosciences Pvt. Ltd
Address
Ahammune Biosciences Pvt. Ltd. Office S1 and S2, ABIL Imperial Commercial Spaces,Baner, Pune- Maharashtra, India
Pune MAHARASHTRA 411045 India
Phone
7755984091
Fax
Email
parul@ahammune.com
Details of Contact Person Public Query
Name
Dr Ramprasath T R
Designation
Associate Director – Operations Monitoring
Affiliation
JSS Medical Research Asia Pacific Private Limited
Address
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no. 12/4, Sector 27D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad-, Haryana, India
Faridabad HARYANA 121003 India
Phone
09444101300
Fax
Email
ramprasath@jssresearch.com
Source of Monetary or Material Support
Ahammune Biosciences Pvt. Ltd.
Office S1 and S2, ABIL Imperial Commercial Spaces,
Baner, Pune-411045
Maharashtra, India
Primary Sponsor
Name
Ahammune Biosciences Pvt. Ltd.
Address
Office S1 and S2, ABIL Imperial Commercial Spaces,
Baner, Pune-411045
Maharashtra, India
IEC-MMC and RI and Associated Hospital, Mysore Medical College and Research Institute Karnataka - 570001
Approved
Institute Ethics Committee All India Institute of Medical Sciences, Old OT Block, Room No. 102, AIIMS Hospital, Ansari Nagar, New Delhi – 110029, India
Approved
Institutional Ethics Committee Rajarajeswari Medical College and HospitalNo. 202, Kambipura, Mysore Road, Bengaluru Karnataka Bengaluru Bengaluru (Bangalore) Urban Karnataka -560074
Approved
Jehangir Clinical Development Center Pvt.Ltd Jehangir hospital premises 32, Sasoon Road Pune Maharashtra - 411001 India
Approved
O AND P Ethics Committee, Phadnis Clinic Pvt Ltd. 1671-75, Behind Hotel Pride, Shivajinagar Pune Maharashtra - 411005 India
Approved
Post Graduate Institute of Medical Education and Research, Room No. 6006, IEC Office, 6th Floor P N Chuttani, Block Chandigarh – 160012 India
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
Part-1
• AB1001 1% topical gel
• AB1001 3% topical gel
AB1001 gel - 1% or 3% - as per randomization schedule - will be applied as a thin film twice daily for 20 weeks to depigmented vitiligo areas, with applications at least 8 hours apart.
Comparator Agent
Part-2
Placebo
As per randomization schedule, either AB1001 gel or placebo will be applied as a thin film twice daily for 24 weeks to depigmented vitiligo areas, with applications at least 8 hours apart. The dose strength for AB1001 gel would be either 1% or 3% based on Part 1 study outcomes.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male and female participants aged 18 years and 65 years, with clinically confirmed diagnosis of non-segmental vitiligo
2. Facial depigmentation involvement of participants with F-VASI ³ 0.25 at screening
3. Total body vitiligo area (facial and non-facial) should not exceed 10 percentage BSA at screening.
4. Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator
5. Willingness to provide written informed consent prior to any study specific procedure.
6. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test
at the screening visit and must agree to use an approved method of highly effective birth control for the duration of the study and for at-least 4 weeks following the last dose of IMP
7. Male participants sexually active with female partners of childbearing potential must agree to use barrier contraception while enrolled in the study and for at-least 4 weeks following the last dose of IMP
ExclusionCriteria
Details
1. Participants with only segmental vitiligo at screening
2. Participants with only acral, oral and,or genital vitiligo at screening
3. Participants with Vitiligo Disease Activity (VIDA) score 3 at screening
4. Participants with dermatologic disease confounding evaluation of vitiligo (e.g. pityriasis alba, piebaldism, idiopathic guttate hypomelanosis, leprosy, tinea versicolor, etc.)
5. Participants with significant leukotrichia in vitiligo lesions
6. Participants receiving medications or investigational drugs within the following period from Randomization:
Corticosteroids
- Topical
- Intralesional, Intraarticular, Or Oral
15 days
-30 days
Minocycline 30 days
Herbal preparations for the treatment of vitiligo [e.g. Rubia cordifolia
(manjistha or majith) and Psoralea coryfolia (bakuchi or bavanchi)] 30 days
Any form of phototherapy, including PUVA, NB-UVB, excimer or laser 30 days
Any approved or experimental biologic 90 days or 5 half-lives
Oral or topical immunomodulators like JAK inhibitors, calcineurin
inhibitors, methotrexate, cyclosporin, or other medications like retinoid 90 days
7. Participants with history of allergic and-or photosensitivity disorders, including photosensitive lupus at screening
8. Any active and-or unstable autoimmune disease judged to be clinically significant by the Investigator
9. Any skin disease (e.g. malignant skin lesions, psoriasis, seborrheic dermatitis, etc.)
that, in the opinion of the Investigator, would interfere with the IMP application or study assessment
10. Participants with previous or current diagnosis of cancer or lymphoproliferative diseases
11. Participants with history of melanocyte-keratinocyte transplantation procedure (MKTP) or other surgical treatment for vitiligo
12. Participants using or with prior history of usage of any depigmentation treatments with drugs such as monobenzyl ether and hydroquinone
13. Participant with a history of serious local infection (e.g., cellulitis, abscess) or systemic infection, or history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to the enrollment visit.
14. Acute or chronic infection, and use of anti-microbials (including anti-bacterial, antiviral, or anti-fungal agents) within 30 days prior to enrollment
15. Participants with a clinically significant abnormal thyroid-stimulating hormone (TSH) or free T4 at screening
16. Any evidence of organ dysfunction or deviation from normal in clinical or laboratory determinations judged to be clinically significant by the Investigator
17. Participants who have any serious concomitant illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g. unstable chronic asthma)
18. Women who are pregnant or lactating at screening
19. Clinically significant abnormal ECG findings at screening
20. Serology tests are 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).
21. Participants not willing to adhere to the protocol requirements
22. For Part 2 study: Participants previously enrolled in Part 1 and received one or more doses of AB1001.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Part 1:
1. The frequency and severity of TEAEs during the study period in both arms
2. Percentage change from baseline in F-VASI at Week 20 in both arms
Part 2:
1. Percentage change from baseline in F-VASI at Week 24 in both arms
Part 1: 20 Weeks
Part 2: 24 Weeks
Secondary Outcome
Outcome
TimePoints
Part 1:
1. Percentage change from baseline in F-VASI at Week 4, Week 8, Week 12 and
Week 16 in both arms
2. Percentage change from baseline in T-VASI at Week 4, Week 8, Week 12, Week
16 & Week 20 in both arms
3. Percentage change from baseline in F-BSA repigmentation at Week 20 in both
arms
4. Percentage change from baseline in T-BSA repigmentation at Week 20 in both
arms
5. Evaluation of DLQI score at baseline & at Week 20 in both arms
6. Evaluation of PGA score for vitiligo at baseline & at Week 20 in both arms
7. Estimation of Cmax, Tmax, AUC0-12 & Ctrough in both arms
Part 1: 20 Weeks
Part 2:
1. Percentage change from baseline in F-VASI at Week 4, Week 8, Week 12, Week 16, & Week 20 in both arms
2. Percentage change from baseline in T-VASI at Week 4, Week 8, Week 12, Week 16, Week 20 & Week 24 in both arms
3. Proportion of Participants achieving greater than equal to 50% improvement in F-VASI (F-VASI50) at Week 4, Week 8, Week 12, Week 16, Week 20 & Week 24 in both arms
4. Proportion of Participants achieving greater than equal to 30% improvement in T-VASI (T-VASI30) at Week 4, Week 8, Week 12, Week 16, Week 20 & Week 24 in both arms
5. Percentage change from baseline in F-BSA & T-BSA repigmentation at Week 24 in both arms
6. Evaluation of DLQI score at baseline & at Week 24 in both arms
Part 2: 24 Weeks
7. Evaluation of PGA score for vitiligo at baseline & at Week 24 in both arms
8. The frequency & severity of TEAEs during the study period in both arms
9. Estimation of Cmax, Tmax, AUC0-12 & Ctrough in both arms
24 Weeks
Target Sample Size
Total Sample Size="130" Sample Size from India="130" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 2
Date of First Enrollment (India)
21/05/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study will be conducted in two parts, Part 1 and Part 2
Part 1: will be an open label study with the objective of establishing safety, tolerability and finding the efficacious dose of AB1001 topical gel. 42 adult participants with nonsegmental vitiligo will be enrolled and randomized in 1:1 ratio to receive either 1% or 3%AB1001 topical gel. Safety, tolerability, indicative efficacy, pharmacokinetic, blood marker and photographic assessment will be conducted as per the Schedule of Assessments (SoA).
Part 2: will be conducted after completion of Part 1 study. This will be a double blind, placebo-controlled study. The safe and efficacious dose strength from Part 1 study will be selected for the Part 2 study. 88 adult participants with non-segmental vitiligo will be enrolled and randomized in 1:1 ratio to receive either the selected strength of AB1001 topical gel or placebo.Efficacy, safety, pharmacokinetic, blood marker and photographic assessment will be conducted as per the SoA.