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

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Status and phase: Active, not recruiting; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: ADX-914; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06018428

SIGNAL-AA (Other Identifier)

ADX-914-203

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. 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)

2. Moderate to severe disease activity at baseline and screening defined as:

   1. SALT score ≥ 50%

Key Exclusion Criteria:

1. Body weight <48 kg or >105 kg at screening.
2. 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
3. History of or diagnosis at screening of another form of alopecia based on assessment by investigator (except for androgenic alopecia).
4. History of male or female pattern hair loss of Hamilton stage >III or Ludwig stage >II.
5. History (lifetime) or presence of hair transplants.
6. History (lifetime) or presence of micropigmentation of the scalp (Note: Microblading of the eyebrows is permitted).
7. Use of systemic, topical, or device-based therapy for AA.
8. History of, recent, or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection or at risk of serious infection.
9. A positive QuantiFERON®TB Gold test at Screening or history of tuberculosis (TB)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Experimental: ADX-914

Experimental group

Description:

200mg dose of ADX-914 administered via injection under the skin every 2 weeks for a total of 24 weeks.

Treatment:

Drug: ADX-914

Placebo Comparator

Placebo Comparator group

Description:

ADX-914 matched placebo administered via injection under the skin every 2 weeks for a total of 24 weeks.

Treatment:

Drug: Placebo