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

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ClinicalTrials.gov Identifier: NCT06018428
Recruitment Status : Recruiting
First Posted : August 30, 2023
Last Update Posted : November 18, 2023
Sponsor:
Collaborator:
Innovaderm Research Inc.
Information provided by (Responsible Party):
Q32 Bio Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : August 28, 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Mean relative percent change in SALT score. [ Time Frame: 24 Weeks ]

Secondary Outcome Measures :
  1. Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18. [ Time Frame: 18 Weeks ]
  2. Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir. [ Time Frame: 24 Weeks ]
  3. Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24. [ Time Frame: 24 Weeks ]
  4. Proportion of participants who achieve ≥30% and ≥50% relative reduction in SALT score compared with baseline at Weeks 12, 18, and 24. [ Time Frame: 24 Weeks ]
  5. Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24. [ Time Frame: 24 Weeks ]
  6. Overall Safety as evaluated by number of adverse events (AEs). [ Time Frame: 40 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06018428


Contacts
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Contact: Kristin Orr 9193950132 korr@q32bio.com

Locations
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United States, Arkansas
Hot Springs, Arkansas Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Kadijah Washington       Kwashington@q32bio.com   
United States, California
Encinitas, California Recruiting
Encinitas, California, United States, 92024
Contact: Kadijah Washington       Kwashington@q32bio.com   
Fountain Valley, California Recruiting
Fountain Valley, California, United States, 92708
Contact: Kadijah Washington       Kwashington@q32bio.com   
United States, Florida
Tampa, Florida Recruiting
Tampa, Florida, United States, 33613
Contact: Kadijah Washington       Kwashington@q32bio.com   
United States, Michigan
Warren, Michigan Recruiting
Warren, Michigan, United States, 48192
Contact: Kadijah Washington       Kwashington@q32bio.com   
United States, New York
New York, New York Recruiting
New York, New York, United States, 11211
Contact: Kadijah Washington       Kwashington@q32bio.com   
United States, Ohio
Bexley, Ohio Recruiting
Bexley, Ohio, United States, 43209
Contact: Kadijah Washington       Kwashington@q32bio.com   
Mason, Ohio Recruiting
Mason, Ohio, United States, 45040
Contact: Kadijah Washington       Kwashington@q32bio.com   
United States, Texas
Austin, Texas Recruiting
Austin, Texas, United States, 78759
Contact: Kadijah Washington       Kwashington@q32bio.com   
Frisco, Texas Recruiting
Frisco, Texas, United States, 75034
Contact: Kadijah Washington       Kwashington@q32bio.com   
Houston, Texas Recruiting
Houston, Texas, United States, 77056
Contact: Kristin Orr       korr@q32bio.com   
San Antonio, Texas Recruiting
San Antonio, Texas, United States, 78213
Contact: Kadijah Washington       Kwashington@q32bio.com   
United States, Utah
Jordan, Utah Recruiting
Jordan, Utah, United States, 84095
Contact: Kadijah Washington       Kwashington@q32bio.com   
United States, Washington
Spokane, Washington Recruiting
Spokane, Washington, United States, 99202
Contact: Kristin Orr       korr@q32bio.com   
Sponsors and Collaborators
Q32 Bio Inc.
Innovaderm Research Inc.
More Information
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Responsible Party: Q32 Bio Inc.
ClinicalTrials.gov Identifier: NCT06018428    
Other Study ID Numbers: ADX-914-203
SIGNAL-AA ( Other Identifier: Q32 Bio )
First Posted: August 30, 2023    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Q32 Bio Inc.:
Areata, Alopecia
Alopecia
Dermatitis
 Hair Loss
Trichoscopy
Atopic
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical