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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FB102 | Active Comparator | Participants will receive FB102. |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FB102 | Drug | Route of administration- Intravenous (IV) |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | 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%). | From Screening through Week 16. |
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Inclusion Criteria:
Males aged 18-60 years and females aged 18-75 years at Screening.
Clinical diagnosis of severe to very severe AA with ≥50% scalp hair loss (including AT or AU) confirmed by SALT score and central photo review; no other cause of hair loss.
Exclusion Criteria:
Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Support Officer | Contact | +61 3 7050 1941 | recruitment@clinibase.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Leonards | Not yet recruiting | Saint Leonards | New South Wales (nsw) | 2065 | Australia | |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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| Drug |
Route of administration- Intravenous (IV) |
|
| Coorparoo |
| Recruiting |
| Coorparoo |
| Queensland |
| 4151 |
| Australia |
| South Yarra | Not yet recruiting | South Yarra | Victoria | 3141 | Australia |
| Auckland | Not yet recruiting | Auckland | Auckland | 0632 | New Zealand |
| Christchurch | Not yet recruiting | Christchurch | Canterbury | 8013 | New Zealand |
| Palmerston North | Not yet recruiting | Palmerston North | Palmerston North Central | 4414 | New Zealand |
| D017437 |
| Skin and Connective Tissue Diseases |