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

Phase 2

Active, not recruiting

• Conditions: Alopecia Areata
• Interventions: Drug: ADX-914; Drug: Placebo

• Registration Number: NCT06018428
• Lead Sponsor: Q32 Bio Inc.

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.

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 Timeline

• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-23
• Study Start: 2023-08-28
• Study First Posted: 2023-08-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: ADX-914	ADX-914	200mg dose of ADX-914 administered via injection under the skin every 2 weeks for a total of 24 weeks.
Placebo Comparator	Placebo	ADX-914 matched placebo administered via injection under the skin every 2 weeks for a total of 24 weeks.

Primary Outcome Measures

Name	Time	Method
Mean relative percent change in SALT score.	24 Weeks

Secondary Outcome Measures

Name	Time	Method
Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18.	18 Weeks
Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24.	24 Weeks
Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir.	24 Weeks
Overall Safety as evaluated by number of adverse events (AEs).	40 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

Trial Locations

Locations (23)

Mayfield Heights, Ohio; 🇺🇸 Mayfield Heights, Ohio, United States

Scottsdale, Arizona; 🇺🇸 Scottsdale, Arizona, United States

Fayetteville, Arkansas; 🇺🇸 Fayetteville, Arkansas, United States

Hot Springs, Arkansas; 🇺🇸 Hot Springs, Arkansas, United States

Fountain Valley, California; 🇺🇸 Fountain Valley, California, United States

Miami, Florida; 🇺🇸 Miami, Florida, United States

Portland, Oregon; 🇺🇸 Portland, Oregon, United States

Warren, Michigan; 🇺🇸 Warren, Michigan, United States

Houston, Texas; 🇺🇸 Houston, Texas, United States

Tampa, Florida; 🇺🇸 Tampa, Florida, United States

Encinitas, California; 🇺🇸 Encinitas, California, United States

Lomita, California; 🇺🇸 Lomita, California, United States

Clarksville, Indiana; 🇺🇸 Clarksville, Indiana, United States

Troy, Michigan; 🇺🇸 Troy, Michigan, United States

New York, New York; 🇺🇸 New York, New York, United States

Wilmington, North Carolina; 🇺🇸 Wilmington, North Carolina, United States

Mason, Ohio; 🇺🇸 Mason, Ohio, United States

Bexley, Ohio; 🇺🇸 Bexley, Ohio, United States

Frisco, Texas; 🇺🇸 Frisco, Texas, United States

San Antonio, Texas; 🇺🇸 San Antonio, Texas, United States

Jordan, Utah; 🇺🇸 Jordan, Utah, United States

Spokane, Washington; 🇺🇸 Spokane, Washington, United States

Austin, Texas; 🇺🇸 Austin, Texas, United States