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

Alopecia Areata Clinical Trial

— SIGNAL-AA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06018428
• Other study ID #: ADX-914-203
• Secondary ID: SIGNAL-AA
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 28, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Q32 Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• ADX-914
Subcutaneous administration of ADX-914
• Placebo
Subcutaneous administration of placebo

Locations

Country	Name	City	State
United States	Austin, Texas	Austin	Texas
United States	Bexley, Ohio	Bexley	Ohio
United States	Clarksville, Indiana	Clarksville	Indiana
United States	Encinitas, California	Encinitas	California
United States	Fayetteville, Arkansas	Fayetteville	Arkansas
United States	Fountain Valley, California	Fountain Valley	California
United States	Frisco, Texas	Frisco	Texas
United States	Hot Springs, Arkansas	Hot Springs	Arkansas
United States	Houston, Texas	Houston	Texas
United States	Jordan, Utah	Jordan	Utah
United States	Lomita, California	Lomita	California
United States	Mason, Ohio	Mason	Ohio
United States	Mayfield Heights, Ohio	Mayfield Heights	Ohio
United States	Miami, Florida	Miami	Florida
United States	New York, New York	New York	New York
United States	Portland, Oregon	Portland	Oregon
United States	San Antonio, Texas	San Antonio	Texas
United States	Scottsdale, Arizona	Scottsdale	Arizona
United States	Spokane, Washington	Spokane	Washington
United States	Tampa, Florida	Tampa	Florida
United States	Troy, Michigan	Troy	Michigan
United States	Warren, Michigan	Warren	Michigan
United States	Wilmington, North Carolina	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Q32 Bio Inc.	Innovaderm Research Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean relative percent change in SALT score.		24 Weeks
Secondary	Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18.		18 Weeks
Secondary	Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir.		24 Weeks
Secondary	Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24.		24 Weeks
Secondary	Proportion of participants who achieve =30% and =50% relative reduction in SALT score compared with baseline at Weeks 12, 18, and 24.		24 Weeks
Secondary	Proportion of participants with absolute SALT score =5, =10, =20, and =30 at Weeks 12, 18, and 24.		24 Weeks
Secondary	Overall Safety as evaluated by number of adverse events (AEs).		40 Weeks