This is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of FB102 in patients with severe to very severe alopecia areata (AA).
Up to approximately 32 participants who meet all the Screening eligibility criteria will be randomized in a 3:1 ratio to receive FB102, or placebo dosing to match.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
St Leonards
Saint Leonards, New South Wales (nsw), Australia
NOT_YET_RECRUITINGCoorparoo
Coorparoo, Queensland, Australia
RECRUITINGSouth Yarra
South Yarra, Victoria, Australia
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Upto 36 Weeks post first dose administration
Change from Baseline of Severity of Alopecia Tool (SALT) score at Week 16.
The Severity of Alopecia Tool (SALT) score ranges from 0 (no scalp hair loss) to 100 (complete scalp hair loss), with higher scores indicating greater severity. Change from baseline in SALT score at Week 16 will assess treatment effect. The AA-IGA categorizes SALT scores as follows: 0 = None (0%), 1 = Limited (1-20%), 2 = Moderate (21-49%), 3 = Severe (50-94%), 4 = Very Severe (95-100%).
Time frame: From Screening through Week 16.
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Auckland
Auckland, Auckland, New Zealand
NOT_YET_RECRUITINGChristchurch
Christchurch, Canterbury, New Zealand
NOT_YET_RECRUITINGPalmerston North
Palmerston North, Palmerston North Central, New Zealand
NOT_YET_RECRUITING