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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)

Primary Purpose

Alopecia Areata

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ADX-914
Placebo
Sponsored by
Q32 Bio Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Areata, Alopecia, Alopecia, Dermatitis, Hair Loss, Trichoscopy, Atopic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Houston, TexasRecruiting
  • Spokane, WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: ADX-914

Placebo Comparator

Arm Description

200mg dose of ADX-914 administered via injection under the skin every 2 weeks for a total of 24 weeks.

ADX-914 matched placebo administered via injection under the skin every 2 weeks for a total of 24 weeks.

Outcomes

Primary Outcome Measures

Mean relative percent change in SALT score.

Secondary Outcome Measures

Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18.
Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir.
Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24.
Proportion of participants who achieve ≥30% and ≥50% relative reduction in SALT score compared with baseline at Weeks 12, 18, and 24.
Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24.
Overall Safety as evaluated by number of adverse events (AEs).

Full Information

First Posted
August 15, 2023
Last Updated
September 12, 2023
Sponsor
Q32 Bio Inc.
Collaborators
Innovaderm Research
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1. Study Identification

Unique Protocol Identification Number
NCT06018428
Brief Title
Randomized, Double-Blind, Placebo-Controlled Phase 2a, Proof-of-Concept Trial of ADX-914 Phase 2a Trial for the Treatment of Severe Alopecia Areata
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Q32 Bio Inc.
Collaborators
Innovaderm Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Areata, Alopecia, Alopecia, Dermatitis, Hair Loss, Trichoscopy, Atopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: ADX-914
Arm Type
Experimental
Arm Description
200mg dose of ADX-914 administered via injection under the skin every 2 weeks for a total of 24 weeks.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
ADX-914 matched placebo administered via injection under the skin every 2 weeks for a total of 24 weeks.
Intervention Type
Drug
Intervention Name(s)
ADX-914
Intervention Description
Subcutaneous administration of ADX-914
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous administration of placebo
Primary Outcome Measure Information:
Title
Mean relative percent change in SALT score.
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18.
Time Frame
18 Weeks
Title
Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir.
Time Frame
24 Weeks
Title
Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24.
Time Frame
24 Weeks
Title
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
Title
Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24.
Time Frame
24 Weeks
Title
Overall Safety as evaluated by number of adverse events (AEs).
Time Frame
40 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Orr
Phone
9193950132
Email
korr@q32bio.com
Facility Information:
Facility Name
Houston, Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Orr
Email
korr@q32bio.com
Facility Name
Spokane, Washington
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Orr
Email
korr@q32bio.com

12. IPD Sharing Statement

Learn more about this trial

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

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