A Phase II, multicenter, randomized study to evaluate safety and efficacy of topical AB1001 in adult patients with non-segmental vitiligo.
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Ahammune Biosciences Pvt. Ltd.
- Enrollment
- 130
- Locations
- 4
- Primary Endpoint
- Part 1:
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and female participants aged 18 years and 65 years, with clinically confirmed diagnosis of non-segmental vitiligo
- •Facial depigmentation involvement of participants with F-VASI ³ 0.25 at screening
- •Total body vitiligo area (facial and non-facial) should not exceed 10 percentage BSA at screening.
- •Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator
- •Willingness to provide written informed consent prior to any study specific procedure.
- •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
- •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
- •Participants with only segmental vitiligo at screening
- •Participants with only acral, oral and,or genital vitiligo at screening
- •Participants with Vitiligo Disease Activity (VIDA) score 3 at screening
- •Participants with dermatologic disease confounding evaluation of vitiligo (e.g. pityriasis alba, piebaldism, idiopathic guttate hypomelanosis, leprosy, tinea versicolor, etc.)
- •Participants with significant leukotrichia in vitiligo lesions
- •Participants receiving medications or investigational drugs within the following period from Randomization: Corticosteroids.
- •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
- •Participants with history of allergic and-or photosensitivity disorders, including photosensitive lupus at screening
- •Any active and-or unstable autoimmune disease judged to be clinically significant by the Investigator
- •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
Outcomes
Primary Outcomes
Part 1:
Time Frame: Part 1: 20 Weeks | Part 2: 24 Weeks
1. The frequency and severity of TEAEs during the study period in both arms
Time Frame: Part 1: 20 Weeks | Part 2: 24 Weeks
2. Percentage change from baseline in F-VASI at Week 20 in both arms
Time Frame: Part 1: 20 Weeks | Part 2: 24 Weeks
Part 2:
Time Frame: Part 1: 20 Weeks | Part 2: 24 Weeks
1. Percentage change from baseline in F-VASI at Week 24 in both arms
Time Frame: Part 1: 20 Weeks | Part 2: 24 Weeks
Secondary Outcomes
- Part 1:(1. Percentage change from baseline in F-VASI at Week 4, Week 8, Week 12 and)
- Part 2:(1. Percentage change from baseline in F-VASI at Week 4, Week 8, Week 12, Week 16, & Week 20 in both arms)
- 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)
Investigators
Dr Davinder Parsad
PGIMER, Chandigarh