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

Last updated: May 9, 2024
Sponsor: Q32 Bio Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hair Loss

Alopecia

Treatment

Placebo

ADX-914

Clinical Study ID

NCT06018428
ADX-914-203
SIGNAL-AA
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Age 18 to 75 years, inclusive, at time of informed consent, with severe AA (durationof current episode of hair loss >6 months and <10 years)
  2. Moderate to severe disease activity at baseline and screening defined as:
  3. SALT score ≥ 50%

Exclusion

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 skinconditions (eg, psoriasis, seborrheic dermatitis, lupus) at the time of screening andthrough Day 1 that, in the opinion of the investigator, may interfere with evaluationof AA and the assessment of the disease activity measures
  3. History of or diagnosis at screening of another form of alopecia based on assessmentby 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: Microbladingof 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, orparasitic infection or mycobacterial infection or at risk of serious infection.
  9. A positive QuantiFERON®TB Gold test at Screening or history of tuberculosis (TB)

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 28, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Scottsdale, Arizona

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Fayetteville, Arkansas

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Hot Springs, AR

    Hot Springs, Arkansas 71913
    United States

    Active - Recruiting

  • Hot Springs, Arkansas

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Encinitas, CA

    Encinitas, California 92024
    United States

    Active - Recruiting

  • Encinitas, California

    Encinitas, California 92024
    United States

    Site Not Available

  • Fountain Valley, CA

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Fountain Valley, California

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Lomita, California

    Lomita, California 90717
    United States

    Site Not Available

  • Miami, Florida

    Miami, Florida 33173
    United States

    Site Not Available

  • Tampa, Florida

    Tampa, Florida 33613
    United States

    Site Not Available

  • Clarksville, Indiana

    Clarksville, Indiana 47129
    United States

    Site Not Available

  • Troy, Michigan

    Troy, Michigan 48084
    United States

    Site Not Available

  • Warren, Michigan

    Warren, Michigan 48192
    United States

    Site Not Available

  • New York, New York

    New York, New York 11211
    United States

    Site Not Available

  • Wilmington, North Carolina

    Wilmington, North Carolina 28405
    United States

    Site Not Available

  • Bexley, OH

    Bexley, Ohio 43209
    United States

    Active - Recruiting

  • Bexley, Ohio

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Mason, Ohio

    Mason, Ohio 45040
    United States

    Site Not Available

  • Mayfield Heights, Ohio

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Portland, Oregon

    Portland, Oregon 97225
    United States

    Site Not Available

  • Austin, Texas

    Austin, Texas 78759
    United States

    Site Not Available

  • Frisco, Texas

    Frisco, Texas 75034
    United States

    Site Not Available

  • Houston, Texas

    Houston, Texas 77056
    United States

    Site Not Available

  • San Antonio, TX

    San Antonio, Texas 78213
    United States

    Active - Recruiting

  • San Antonio, Texas

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Jordan, Utah

    Jordan, Utah 84095
    United States

    Site Not Available

  • Spokane, Washington

    Spokane, Washington 99202
    United States

    Site Not Available

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