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ADX-914 for Severe Alopecia Areata (SIGNAL-AA Trial)

Q: Is this research accommodating seniors as participants?

This clinical trial allows participants aged 18 to 75. Additionally, there are 16 trials open for minors and 62 studies aimed at seniors.

Q: To which demographic is participation in this research available?

The requirements to join this clinical trial require participants to have been diagnosed with <a href="https://www.withpower.com/clinical-trials/alopecia-areata">alopecia areata</a> and be between the ages of 18-75. Approximately 40 people are being sought for enrolment.

Q: What is the current participant count for this experiment?

Affirmative. Per the information on clinicaltrials.gov, this study is presently seeking volunteers to participate in their research. The trial was first announced August 28th 2023 and last updated September 12th 2023 with an aim of recruiting 40 patients from two different sites.

Q: How detrimental is the application of ADX-914 to a patient's health?

ADX-914's safety has been moderately evaluated, resulting in a score of 2 on our scale. This is because the drug is currently undergoing Phase 2 clinical trials and there are some studies which support its safety but no data concerning effectiveness yet.

Q: Is this research endeavor in search of new participants?

Affirmative. Clinicaltrials.gov data displays that this clinical trial, initially posted on August 28th 2023, is actively looking for study participants. 40 people must be recruited from 2 sites to complete the research project.

Phase 2

Recruiting

Research Sponsored by Q32 Bio Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate to severe disease activity at baseline and screening defined as SALT score ≥ 50%

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 40 weeks

Awards & highlights

SIGNAL-AA Trial Summary

This trial tests a potential treatment for a rare hair-loss condition. Patients are randomly given medication or placebo.

Who is the study for?

This trial is for adults aged 18-75 with severe Alopecia Areata, having lost hair for more than 6 months but less than 10 years. Participants must have a significant degree of hair loss at the start. Those with other skin conditions, different alopecia types, extreme body weights, scalp treatments like transplants or micropigmentation, recent serious infections or TB can't join.Check my eligibility

What is being tested?

The study tests ADX-914 against a placebo in people with severe Alopecia Areata to see if it helps regrow hair. It's randomized (participants are put into groups by chance), double-blind (neither participants nor researchers know who gets what treatment), and placebo-controlled (some get the real drug; others get an inactive substance).See study design

What are the potential side effects?

Potential side effects of ADX-914 aren't specified here but could include reactions similar to other medications treating skin conditions such as redness, itching, or irritation at the application site.

SIGNAL-AA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My condition is moderate to severe with a SALT score of 50% or higher.

Select...

I am between 18 and 75 years old and have had severe alopecia areata for more than 6 months but less than 10 years.

SIGNAL-AA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 40 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~40 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean relative percent change in SALT score.

Secondary outcome measures

Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24.

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.

+3 more

SIGNAL-AA Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: ADX-914Experimental Treatment1 Intervention

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

Group II: Placebo ComparatorPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ADX-914

2020

Completed Phase 1

~50

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Innovaderm ResearchUNKNOWN

1 Previous Clinical Trials

29 Total Patients Enrolled

Q32 Bio Inc.Lead Sponsor

2 Previous Clinical Trials

144 Total Patients Enrolled

Innovaderm Research Inc.OTHER

48 Previous Clinical Trials

3,176 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research accommodating seniors as participants?

"This clinical trial allows participants aged 18 to 75. Additionally, there are 16 trials open for minors and 62 studies aimed at seniors."

Answered by AI

To which demographic is participation in this research available?

"The requirements to join this clinical trial require participants to have been diagnosed with alopecia areata and be between the ages of 18-75. Approximately 40 people are being sought for enrolment."

Answered by AI

What is the current participant count for this experiment?

"Affirmative. Per the information on clinicaltrials.gov, this study is presently seeking volunteers to participate in their research. The trial was first announced August 28th 2023 and last updated September 12th 2023 with an aim of recruiting 40 patients from two different sites."

Answered by AI

How detrimental is the application of ADX-914 to a patient's health?

"ADX-914's safety has been moderately evaluated, resulting in a score of 2 on our scale. This is because the drug is currently undergoing Phase 2 clinical trials and there are some studies which support its safety but no data concerning effectiveness yet."

Answered by AI

Is this research endeavor in search of new participants?

"Affirmative. Clinicaltrials.gov data displays that this clinical trial, initially posted on August 28th 2023, is actively looking for study participants. 40 people must be recruited from 2 sites to complete the research project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Randomized, Double-Blind, Placebo-Controlled Phase 2a, Proof-of-Concept Trial of ADX-914 Phase 2a Trial for the Treatment of Severe Alopecia Areata". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06018428.

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