Alopecia Areata
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Alopecia Areata
ADX-914-203 Enrolling

Severe Alopecia Areata Research Trial (40 Weeks)


Treatment: Injection Age: 18 Years


Who Can Participate

Adults 18-75 years with a diagnosis of severe or very severe alopecia areata (AA) may participate.

Eligibility Criteria

  • Clinical diagnosis of severe or very severe AA (50% or more total scalp hair loss)
  • Current episode of hair loss has been for more than 6 months (but less than 10 years)
  • No history or presence of hair transplants
  • Willingness to keep the same hair style and color (eg. Hair products, process, and timing of hair appointments) for the study’s duration

What Are The Benefits?

  • No cost to participate or receive treatment
  • Regular visits with study doctors who specialize in treating AA (17 visits)
  • Will receive either an investigative injection treatment (study drug) or a placebo
  • Reimbursement for study-related expenses may be provided 

How Long Will The Study Last?

  • 40 weeks

Note: Participants may not be engaged in any other kind of systemic, topical, or device-based therapy for AA.


Participating Locations

COUNTRY
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United States

Participating Experts

Dr. Rocco Serrao

Dermatologist

Dr. Matthew Zirwas

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: February 25, 2024

Official Title

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

ClinicalTrials.gov ID

NCT06018428

Sponsor

Q32 Bio Inc.

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:

    Alopecia Areata

  • Intervention/Treatment:

    Drug: ADX-914
    Drug: Placebo
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 75 Years (Adult)

  • Sexes Eligible for Study:

    All

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 >II.
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)


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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