ANB032 for Eczema

Recruiting at 160 trial locations

Overseen By Aaron Ilan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AnaptysBio, Inc.

Disqualifiers: Immunodeficiency, Infection risk, Sun exposure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

201 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called ANB032 for people with moderate to severe atopic dermatitis, a skin condition that causes itching and inflammation. The study will check if ANB032 is safe and effective in reducing these symptoms by targeting the immune system. Researchers want to see if this new treatment can help those who have not responded well to other treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the drug ANB032 differ from other eczema treatments?

ANB032 is unique because it targets the IL-33 pathway, which plays a key role in the inflammation and itch-scratch cycle of eczema. This approach is different from traditional treatments that focus on moisturizing or general anti-inflammatory effects. ^{1 2 3 4 5}

Research Team

Mark Rigby, MD

Principal Investigator

AnaptysBio, Inc.

Eligibility Criteria

Adults aged 18-65 with moderate to severe atopic dermatitis (AD) for at least 6 months, who haven't responded well to topical treatments or can't use them. Participants must have certain scores on AD severity scales and at least 10% of their body surface area affected.

Inclusion Criteria

I am between 18 and 65 years old and in good health.

I have had moderate to severe atopic dermatitis for at least 6 months.

Your skin condition score is 16 or higher at the initial screening and at the time of randomization.

Exclusion Criteria

I cannot tolerate drugs given under the skin.

I haven't used a tanning booth or had long sun exposure in the last 4 weeks.

Any factors that in the Investigator's opinion would predispose the subject to develop an infection

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ANB032 or placebo subcutaneously for 14 weeks

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ANB032

Trial Overview The trial is testing ANB032 against a placebo to see if it's safe, tolerable, and effective in treating AD. Patients will be randomly assigned to receive either the actual drug or a placebo without knowing which one they're getting.

Participant Groups

Group I: ANB032 SC Dose 3 Experimental Treatment 1 Intervention

This arm will receive treatment SC

Group II: ANB032 SC Dose 2 Experimental Treatment 1 Intervention

This arm will receive treatment SC

Group III: ANB032 SC Dose 1 Experimental Treatment 1 Intervention

This arm will receive treatment SC

Group IV: Placebo Placebo Group 1 Intervention

This arm will receive Placebo SC

Who Is Running the Clinical Trial?

AnaptysBio, Inc.

Lead Sponsor

Trials

17

Recruited

1,700+

Findings from Research

A barrier-improving cream containing 5% urea significantly reduced the risk of eczema relapse in patients with atopic dermatitis by 37%, based on a multicenter randomized controlled trial.

Patients using the urea cream experienced a longer median time to relapse (22 days) compared to those using a reference cream (15 days), and 26% of patients remained eczema-free at 6 months, indicating its efficacy and good tolerance in treating atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Moisturizing Creams for the Prevention of Atopic Dermatitis Relapse: A Randomized Double-blind Controlled Multicentre Clinical Trial. Åkerström, U., Reitamo, S., Langeland, T., et al.[2022]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Comparison of Moisturizing Creams for the Prevention of Atopic Dermatitis Relapse: A Randomized Double-blind Controlled Multicentre Clinical Trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Interleukin-33 in atopic dermatitis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Anti-IL-33 Antibody Has a Therapeutic Effect in an Atopic Dermatitis Murine Model Induced by 2, 4-Dinitrochlorobenzene. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Proof-of-concept clinical trial of etokimab shows a key role for IL-33 in atopic dermatitis pathogenesis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

IL-32γ suppressed atopic dermatitis through inhibition of miR-205 expression via inactivation of nuclear factor-kappa B. [2021]