Health Condition 1: L80- Vitiligo
Conditions
Interventions
Intervention1: 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
Sponsors
Ahammune Biosciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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 enrolle
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Timepoint: Part 1: 20 Weeks Part 2: 24 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: 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 Timepoint: 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 Timepoint: 24 Weeks | — |
Countries
India
Contacts
Public ContactDr Ramprasath T R
Ahammune Biosciences Pvt. Ltd
Outcome results
None listed