ANB032 for Eczema

No longer recruiting at 170 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ANB032 for individuals with moderate to severe eczema (also known as atopic dermatitis or AD). The goal is to assess the safety and effectiveness of ANB032 at various doses compared to a placebo (a harmless, inactive substance). Those who have had eczema for at least six months and haven't found success with other treatments might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ANB032 is generally safe and well-tolerated in earlier studies. Most people can use the treatment without major problems. Some side effects might occur, but serious issues are rare. Although the treatment is still being tested for eczema, these early results are promising. ^{1 2 3 4 5}

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

Researchers are excited about ANB032 for eczema because it represents a novel approach compared to standard treatments like topical corticosteroids and calcineurin inhibitors. ANB032 is unique as it targets a specific immune pathway related to eczema, potentially offering a more targeted and effective option. This treatment is administered subcutaneously, which could provide longer-lasting relief with fewer applications. By focusing on a different mechanism of action, ANB032 might reduce inflammation and itching more efficiently, offering hope for those who haven't found success with existing therapies.

What evidence suggests that ANB032 could be an effective treatment for atopic dermatitis?

Research has shown that ANB032, a drug affecting the immune system, has not succeeded in treating moderate to severe atopic dermatitis (a form of eczema) in past studies. Specifically, the ARISE-AD trial found that none of the doses improved eczema symptoms as expected. Although ANB032 was safe and interacted with its intended target in the body, it did not significantly reduce eczema symptoms. This indicates that while the treatment showed some activity in the body, previous research has not proven it effective for treating eczema. ^{1 2 4 5 6}

Who Is on the Research Team?

Mark Rigby, MD

Principal Investigator

AnaptysBio, Inc.

Are You a Good Fit for This Trial?

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 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.

Topical treatments for my skin condition were ineffective or not recommended for me.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. ir.anaptysbio.com ir.anaptysbio.com/news-releases/news-release-details/anaptys-announces-phase-2b-trial-anb032-btla-agonist-did-not

Anaptys Announces Phase 2b Trial of ANB032, a BTLA ... ANB032, a BTLA agonist, did not meet the primary and secondary endpoints in any of the doses studied in the global, 201-patient ARISE-AD trial as a monotherapy.

2. clinicaltrialsarena.com clinicaltrialsarena.com/news/anaptysbios-atopic-dermatitis-trial/

AnaptysBio's atopic dermatitis trial of BTLA agonist misses ... AnaptysBio has reported that the ARISE-AD trial of ANB032, for treating moderate-to-severe atopic dermatitis failed to meet both endpoints.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05935085

NCT05935085 | This Study Will Evaluate the Safety, ... This study will evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate to severe atopic dermatitis (AD). Detailed Description. This ...

4. ajmc.com ajmc.com/view/dr-martin-dahl-summarizes-findings-limitations-of-study-analyzing-anb032-use-in-patients-with-ad

Dr Martin Dahl Summarizes Findings, Limitations of Study ... Martin Dahl, PhD, of AnaptysBio discusses the findings and limitations of a study analyzing use of ANB032 in patients with atopic dermatitis (AD).

5. jidonline.org jidonline.org/article/S0022-202X(23)02693-3/fulltext

89 A phase 2b, randomized, double-blind, placebo ... In a Phase 1 healthy volunteer study, ANB032 was well-tolerated, had a favorable PK profile, demonstrated robust target engagement, and partial reduction in ...

6. anaptysbio.com anaptysbio.com/wp-content/uploads/Ph2-TiP-poster-ISDS-2023.pdf

A Phase 2b, Randomized, Double-blind, Placebo- ... This study of ANB032 will further the understanding of the biology of this heterogenous disease. ABSTRACT. Unmet Need in Atopic Dermatitis (AD).