ATTO-1310 for Atopic Dermatitis

Recruiting at 14 trial locations

Overseen By Malinda Longphre, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Attovia Therapeutics Inc

Must be taking: Topical emollients

Must not be taking: Topical corticosteroids, Biologics

Disqualifiers: Asthma, HIV, Tuberculosis, others

Compensation: Varies

Number of Visits: Unknown

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ATTO-1310 for atopic dermatitis, a condition that causes itchy, inflamed skin. The main focus is to determine the safety of ATTO-1310 and how it behaves in the body compared to a placebo (a harmless substance with no active drug). Participants will receive either the treatment or placebo and report any symptoms. Individuals who have had atopic dermatitis for over a year and experience frequent itching may be a good fit for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires participants with atopic dermatitis to stop using certain medications before starting, including topical corticosteroids, oral antihistamines, and other specified treatments. The protocol mentions a washout period (time without taking certain medications) for these drugs before Day 1 of the trial.

Is there any evidence suggesting that ATTO-1310 is likely to be safe for humans?

Research has shown that ATTO-1310 is generally safe so far, meaning people taking it usually do not experience severe side effects. In studies with healthy adults, whether they received one dose or several, ATTO-1310 was well-tolerated, with few serious problems reported by participants.

The trial is in its early phase, primarily assessing the safety of the new treatment. While more information is needed to fully understand its safety, early results are promising. Participants have reported positive experiences regarding safety, with the treatment aimed at relieving itch without causing major issues.

For those considering joining a clinical trial, current evidence suggests the treatment is likely to be well-tolerated. However, as with any new treatment, some risk is always involved. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ATTO-1310 for atopic dermatitis because it offers a new approach with its Attobody technology. Unlike standard treatments like topical corticosteroids or calcineurin inhibitors that primarily reduce inflammation on the skin's surface, ATTO-1310 targets specific pathways involved in the immune response. This novel mechanism could provide more effective relief for patients with different delivery options, such as single or multiple doses given intravenously (IV) or subcutaneously (SC). Moreover, the potential for tailored dosing strategies means it could be adapted to better meet individual patient needs, setting it apart from current options.

What evidence suggests that ATTO-1310 might be an effective treatment for atopic dermatitis?

Studies have shown that ATTO-1310, a new treatment tested in this trial, could quickly and effectively relieve itching. This treatment targets a protein called IL31, linked to itchiness in conditions like atopic dermatitis. Research on similar treatments focusing on this protein has shown promising results in reducing itch. Early findings suggest that ATTO-1310 may be safe and provide significant itch relief. However, more information is needed to confirm its effectiveness for people with atopic dermatitis. Participants in this trial may receive ATTO-1310 in different forms, such as single or multiple doses, administered either intravenously or subcutaneously. ^{1 2 3 4 6}

Who Is on the Research Team?

Eric Sicard, MD

Principal Investigator

Altasciences Company Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults and those with atopic dermatitis, a type of eczema causing itchy inflammation of the skin. Participants must be willing to take ATTO-1310 or a placebo, attend clinic visits, and record their symptoms in a diary.

Inclusion Criteria

I am not pregnant and can have children.

I have been diagnosed with active Atopic Dermatitis.

Subjects with Atopic Dermatitis: Agreement to use highly effective forms of birth control for subjects of childbearing potential

Exclusion Criteria

I haven't had cancer in the last 5 years, with some exceptions.

Healthy Volunteers: Enrollment in another investigational study

Healthy Volunteers: Abnormal laboratory values

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive a single ascending dose of ATTO-1310 or placebo to assess safety, tolerability, and pharmacokinetics

16 weeks

Multiple visits for dosing and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of ATTO-1310 or placebo to assess safety, tolerability, and pharmacokinetics

20 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ATTO-1310

Trial Overview

The study tests the safety and how well the body handles ATTO-1310 compared to a placebo. It looks into what side effects occur and measures how long the drug stays active in participants' bodies after they take it.

How Is the Trial Designed?

Group I: ATTO-1310 single dose SC Experimental Treatment 1 Intervention

ATTO-1310 Attobody Dose level cohorts receiving a single dose SC

Group II: ATTO-1310 single dose IV Experimental Treatment 1 Intervention

ATTO-1310 Attobody Dose level cohorts receiving a single dose IV

Group III: ATTO-1310 multiple dose SC Experimental Treatment 1 Intervention

ATTO-1310 Attobody administered to dose level cohorts in multiple SC doses

Group IV: ATTO-1310 Placebo single dose IV Placebo Group 1 Intervention

Placebo preparation to match Experimental Arm with single dose IV

Group V: ATTO-1310 Placebo single dose SC Placebo Group 1 Intervention

Placebo preparation to match Experimental Arm with single dose SC

Group VI: ATTO-1310 Placebo multiple dose SC Placebo Group 1 Intervention

Placebo preparation to match Experimental Arm administered in multiple SC doses

Who Is Running the Clinical Trial?

Attovia Therapeutics Inc

Lead Sponsor

Trials

1

Recruited

100+

Published Research Related to This Trial

Atopic dermatitis affects a significant portion of the population, particularly children, and can lead to various psychological and social issues, costing the US economy between $0.9 to 3.8 billion annually.

Topical treatments like steroids and calcineurin inhibitors are effective and safe options for managing atopic dermatitis, while systemic immunomodulators are reserved for severe cases, providing a range of therapeutic choices for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New and emerging trends in the treatment of atopic dermatitis. Gelbard, CM., Hebert, AA.[2021]

Recent advancements in understanding atopic dermatitis (AD) have led to new FDA-approved therapies like crisaborole and dupilumab, which target specific pathways for increased efficacy and potentially fewer side effects compared to traditional treatments.

JAK-STAT inhibitors, such as baricitinib and upadacitinib, show particularly promising results in clinical studies, indicating a shift towards more effective and targeted therapies for managing AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New and Emerging Therapies for Pediatric Atopic Dermatitis. Nguyen, HL., Anderson, KR., Tollefson, MM.[2022]

In a study of 901 patients with moderate-to-severe atopic dermatitis, upadacitinib combined with topical corticosteroids (TCS) showed sustained efficacy over 52 weeks, with 50.8% and 69.0% of patients achieving significant skin improvement (EASI-75) at the lower and higher doses, respectively.

The treatment was well tolerated, with no new safety risks identified over the year-long study, and serious adverse events were rare, indicating a favorable long-term safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results. Silverberg, JI., de Bruin-Weller, M., Bieber, T., et al.[2022]

In a study of 45 children with atopic dermatitis (AD) treated with betamethasone ointment, levels of interleukin 1 beta (IL-1β) were found to be elevated during disease activity and significantly decreased after achieving a 75% improvement in symptoms.

The results suggest that IL-1β levels correlate with the severity of AD, indicating that monitoring this cytokine could help tailor treatments, and highlight the potential for exploring new therapies like cytokine monoclonal antibodies in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of topically applied corticosteroids on interleukin 1β levels in patients with atopic dermatitis. Nutan, FN., Kanwar, AJ., Parsad, D.[2022]

Dupilumab demonstrated a consistent safety profile over long-term treatment in 1491 patients with moderate to severe atopic dermatitis, with no new safety concerns identified and common side effects including nasopharyngitis and conjunctivitis.

Patients experienced sustained improvements in skin inflammation, itching, and quality of life over a treatment period of up to 76 weeks, supporting dupilumab's efficacy as a long-term therapy for atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study. Deleuran, M., Thaçi, D., Beck, LA., et al.[2020]

Recent advancements in understanding the mechanisms of atopic dermatitis have led to the development of new targeted therapies, such as dupilumab, which aim to control inflammation by neutralizing specific mediators and cytokines.

The field is moving towards personalized medicine, allowing for the classification of patients based on their unique inflammatory profiles, which could enhance treatment efficacy in managing moderate-to-severe atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New and Potential Treatments for Atopic Dermatitis: Biologicals and Small Molecules. Sánchez-Borges, M., Capriles-Hulett, A., Ortega-Martell, JA., et al.[2020]

In a 24-week clinical trial involving 692 adults with moderate-to-severe atopic dermatitis, upadacitinib was found to be more effective than dupilumab, with 71% of patients achieving significant skin improvement (EASI75) compared to 61% for dupilumab at week 16.

Upadacitinib also led to faster improvements in itch severity, showing significant results as early as week 1, while both treatments had different safety profiles, with upadacitinib associated with higher rates of serious infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. Blauvelt, A., Teixeira, HD., Simpson, EL., et al.[2022]

Despite extensive research on atopic dermatitis (AD), no reliable diagnostic biomarker or predictor of treatment response has been established, highlighting a gap in personalized treatment approaches.

New treatments for AD, including JAK inhibitors and antibody therapies targeting IL-4/13 and other pathways, are advancing in clinical trials and may soon provide effective options for managing different eczema subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atopic dermatitis - Perspectives and unmet medical needs. Buhl, T., Werfel, T.[2023]

Citations

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The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of ATTO-1310 in healthy adults, patients with atopic dermatitis ...

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First Patient Dosed in Phase 1 Study of Attovia's ATTO- ...

ATTO-1310 aims to fill this void with a therapeutic profile of rapid, deep, and sustained itch relief, a favorable safety profile, and ...

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ATTO-1310 for Atopic Dermatitis

The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of ATTO-1310 in healthy adults, patients with atopic dermatitis and ...

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Patient Page

This study will first evaluate the safety and tolerability of ATTO-1310 in healthy adults after receiving single and multiple doses. The study ...

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Nemolizumab, which binds IL31RA, has shown promising anti-pruritic efficacy in clinical trials, providing validation that targeting the IL31 ...

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Attovia Begins Phase 1 Trial of ATTO-1310 for Chronic ...

ATTO-1310 has the potential to achieve a best-in-disease therapeutic profile in pruritic disease with rapid and deep relief of itch, benign ...