Randomized, Double-Blind, Placebo-Controlled Phase 2a, Proof-of-Concept Trial of ADX-914 Phase 2a Trial for the Treatment of Severe Alopecia Areata

Study Overview
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Brief Summary
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This is a Phase IIa, Randomized, Double-blind, Placebo-controlled, multi-center Proof-of-Concept (POC) Trial in subjects with severe Alopecia Areata.

Detailed Description
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This is a Phase IIa, Randomized, Double-blind, Placebo-controlled, multi-center Proof-of-Concept (POC) study in adult subjects with severe Alopecia Areata (AA). ADX-914 or matching placebo is administered subcutaneously in the clinic setting every 2 weeks for 24 weeks, with follow-up for 12 weeks. Subjects will be randomized 3:1 to drug vs placebo.

Official Title
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A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Proof-of-Concept Trial of ADX-914 for the Treatment of Severe Alopecia Areata

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: ADX-914
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Age 18 to 75 years, inclusive, at time of informed consent, with severe AA (duration of current episode of hair loss >6 months and <10 years) Moderate to severe disease activity at baseline and screening defined as: SALT score ≥ 50% Key Exclusion Criteria: Body weight <48 kg or >105 kg at screening. Active forms of other inflammatory skin disease(s) or evidence of other skin conditions (eg, psoriasis, seborrheic dermatitis, lupus) at the time of screening and through Day 1 that, in the opinion of the investigator, may interfere with evaluation of AA and the assessment of the disease activity measures History of or diagnosis at screening of another form of alopecia based on assessment by investigator (except for androgenic alopecia). History of male or female pattern hair loss of Hamilton stage >III or Ludwig stage >II. History (lifetime) or presence of hair transplants. History (lifetime) or presence of micropigmentation of the scalp (Note: Microblading of the eyebrows is permitted). Use of systemic, topical, or device-based therapy for AA. History of, recent, or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection or at risk of serious infection. A positive QuantiFERON®TB Gold test at Screening or history of tuberculosis (TB)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: ADX-914<br>200mg dose of ADX-914 administered via injection under the skin every 2 weeks for a total of 24 weeks. | Drug: ADX-914<br>* Subcutaneous administration of ADX-914<br>|
| Placebo Comparator: Placebo Comparator<br>ADX-914 matched placebo administered via injection under the skin every 2 weeks for a total of 24 weeks. | Drug: Placebo<br>* Subcutaneous administration of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean relative percent change in SALT score. |  | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18. |  | 18 Weeks | 
| Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir. |  | 24 Weeks | 
| Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24. |  | 24 Weeks | 
| Proportion of participants who achieve ≥30% and ≥50% relative reduction in SALT score compared with baseline at Weeks 12, 18, and 24. |  | 24 Weeks | 
| Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24. |  | 24 Weeks | 
| Overall Safety as evaluated by number of adverse events (AEs). |  | 40 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Areata, Alopecia, Alopecia, Dermatitis, Hair Loss, Trichoscopy, Atopic