CTRI

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CTRI Number

CTRI/2025/10/095999 [Registered on: 13/10/2025] Trial Registered Prospectively

Last Modified On:

19/02/2026

Post Graduate Thesis

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
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 4
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Bangaru H	K.R Hospital	Department of Dermatology, K.R Hospital attached to MMC & RI, Irwin Road,570001,Mysuru, Karnataka, India Mysore KARNATAKA	8212520512 mmcrimysore@yahoo.com
Dr Hemant Kumar Talnikar	Oyster & Pearl Hospital (Phadnis Clinic Pvt Ltd)	1671-75, Ganeshkhind Road, Shivajinagar, pune Pune MAHARASHTRA	9657890464 drhemanthkumar90@gmail.com
Dr Vinay Keshavmurthy	PGIMER	Department of Dermatology, Sector 12, Chandigarh - 160012, India Chandigarh CHANDIGARH	8872993222 vinay.keshavmurthy@gmail.com
Dr Hari Kishan Kumar Y	RajaRajeswari Medical College & Hospital	202, Kambipura,Mysore Road, Banglore-560074 Bangalore KARNATAKA	762801520 drharikishankumar@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 4
Name of Committee	Approval Status
IEC-MMC and RI and Associated Hospital Mysore Medical College and Research Institute Irwin Road Mysuru Mysuru, Mysore Karnataka -570001 India	Submittted/Under Review
Institutional Ethics Committee Rajarajeswari Medical College and HospitalNo. 202, Kambipura, Mysore Road, Bengaluru Karnataka Bengaluru Bengaluru (Bangalore) Urban Karnataka -560074	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	Submittted/Under Review

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)

10/09/2026

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 Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

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.