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

Sponsor

Q32 Bio Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06018428

Collaborator

Innovaderm Research (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Drug: ADX-914 Drug: Placebo	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Experimental: ADX-914

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

Drug: ADX-914

Subcutaneous administration of ADX-914

Placebo Comparator: Placebo Comparator

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

Drug: Placebo

Subcutaneous administration of placebo

Outcome Measures

Primary Outcome Measures

Mean relative percent change in SALT score. [24 Weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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)