96 Participants Needed

ATI-045 for Eczema

Recruiting at 31 trial locations
AC
Overseen ByAclaris Clinical Operations
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ATI-045, a potential drug for moderate-to-severe atopic dermatitis, commonly known as eczema. Participants will receive either ATI-045 or a placebo (a pill with no active medication) to compare results. The trial aims to determine if ATI-045 can improve skin health and reduce symptoms more effectively than the placebo. Ideal candidates have experienced moderate-to-severe eczema for at least six months, have had no major flare-ups recently, and have not found success with previous topical treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

Yes, you may need to stop certain medications before joining the trial. For example, you must stop using topical antibiotics, certain oral medications, and biologics for eczema for a specific time before the trial starts. It's best to discuss your current medications with the trial team to see if any need to be paused.

Is there any evidence suggesting that ATI-045 is likely to be safe for humans?

Research shows that ATI-045 has been tested in people before. Earlier studies found that most participants tolerated it well, without reporting major side effects. While this does not guarantee the absence of side effects, it suggests that ATI-045 is likely safe based on past trials. This trial aims to provide further insights into its safety for treating eczema.12345

Why do researchers think this study treatment might be promising for eczema?

ATI-045 is unique because it offers a novel approach to treating eczema by potentially targeting the underlying inflammation differently than current options like topical steroids or calcineurin inhibitors. Unlike conventional treatments that primarily focus on managing symptoms, ATI-045 may work by modulating specific immune pathways, offering a more targeted method of reducing inflammation and itchiness associated with eczema. Researchers are excited about ATI-045 because it might provide a more effective and faster-acting solution with potentially fewer side effects, improving the quality of life for those affected by this chronic skin condition.

What evidence suggests that ATI-045 might be an effective treatment for eczema?

Studies have shown that ATI-045, also known as bosakitug, is under investigation as a treatment for moderate-to-severe atopic dermatitis, a chronic skin condition causing itchy, inflamed, and scaly rashes. Early research suggests that ATI-045 might reduce symptoms of this condition. Although results from human trials are not yet available to confirm its effectiveness, researchers are carefully studying the treatment for potential benefits. Participants in this trial will receive either ATI-045 or a placebo, providing more information. Initial findings offer hope for those dealing with this challenging skin disorder.36789

Are You a Good Fit for This Trial?

This trial is for individuals with moderate-to-severe atopic dermatitis, which includes conditions like eczema and various forms of dermatitis. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.

Inclusion Criteria

My skin condition didn't improve with creams or using them is not advised for me.
I have had chronic eczema for over 6 months with no severe flare-ups recently.
I have moderate to severe atopic dermatitis currently.
See 2 more

Exclusion Criteria

History of anaphylaxis following biologic therapy
History of allergy to corticosteroids, diphenhydramine, hydroxyzine, cetirizine, or fexofenadine.
I haven't used certain medications or treatments for my skin condition recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ATI-045 or placebo for the treatment of moderate-to-severe atopic dermatitis

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ATI-045
  • Placebo
Trial Overview The study is testing ATI-045 against a placebo to see if it's effective in treating moderate-to-severe atopic dermatitis. Participants will either receive the actual medication or a placebo without knowing which one they're getting.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ATI-045 groupExperimental Treatment1 Intervention
Group II: Placebo groupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aclaris Therapeutics, Inc.

Lead Sponsor

Trials
35
Recruited
4,900+

Citations

Aclaris Therapeutics Initiates Phase 2 Trial of Bosakitug (ATI ...This randomized, double-blind, placebo-controlled global Phase 2 trial is designed to evaluate the efficacy and safety of bosakitug in approximately 90 ...
Aclaris Therapeutics Initiates Phase 2 Trial of Bosakitughas initiated a randomized, double-blind, placebo-controlled Phase 2 trial of bosakitug (ATI-045) in patients with moderate-to-severe atopic dermatitis (AD).
Study to evaluate ATI-045 injection compared to placebo in ...This study focuses on patients with moderate-to-severe atopic dermatitis, a chronic skin condition causing itchy, inflamed, and scaly rashes.
Aclaris Therapeutics' ATI-045 Study: A Potential Game ...The study aims to assess the effectiveness and safety of ATI-045, a potential treatment for atopic dermatitis, a condition affecting millions ...
Aclaris Therapeutics Initiates Phase 2 Trial of Bosakitug ...It has initiated a randomized, double-blind, placebo-controlled Phase 2 trial of bosakitug (ATI-045) in patients with moderate-to-severe atopic dermatitis (AD).
Clinical TrialsAclaris is currently recruiting subjects aged 18 to 70 years of age with moderate to severe atopic dermatitis (eczema) to take part in a research study.
Aclaris Therapeutics Initiates Phase 2 Trial of Bosakitug ...This randomized, double-blind, placebo-controlled global Phase 2 trial is designed to evaluate the efficacy and safety of bosakitug in ...
ATI-045 for Eczema · Recruiting Participants for Phase ...Prior Safety DataThis treatment has passed at least one previous human trial ... This study evaluates ATI-045 versus placebo in patients with Moderate-to-Severe ...
Atopic Dermatitis Study (34 Weeks)This study evaluates ATI-045 versus placebo in patients with Moderate-to-Severe Atopic Dermatitis. Condition or Disease: Atopic Dermatitis, ...
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