ATTO-1310 for Atopic Dermatitis

Overseen by Eric Sicard, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Attovia Therapeutics Inc

Must be taking: Topical emollients

Must not be taking: Topical corticosteroids, Biologics

Disqualifiers: Asthma, HIV, Tuberculosis, others

Trial Summary

What is the purpose of this trial?

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 patients with chronic pruritus. The main questions it aims to answer are: What medical problems do participants have when taking ATTO-1310? How long does ATTO-1310 stay in the body after dosing? Researchers will compare ATTO-1310 to a placebo (a look-alike substance that contains no drug). Participants will be dosed with ATTO-1310 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.

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.

What data supports the effectiveness of the drug ATTO-1310 for atopic dermatitis?

Research on atopic dermatitis shows that treatments targeting specific pathways, like JAK inhibitors, have shown promising results. Since ATTO-1310 is a drug for atopic dermatitis, it may work similarly to these effective treatments. ^{1 2 3 4 5}

How is the drug ATTO-1310 different from other treatments for atopic dermatitis?

ATTO-1310 may offer a novel approach to treating atopic dermatitis, potentially differing in its mechanism of action or formulation compared to existing treatments like topical steroids and systemic immunomodulators, which are commonly used for this condition. ^{2 4 6 7 8}

Research Team

Eric Sicard, MD

Principal Investigator

Altasciences Company Inc.

Eligibility Criteria

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 have been diagnosed with active Atopic Dermatitis.

I am not pregnant and can have children.

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

Trial Timeline

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

Treatment Details

Interventions

• ATTO-1310 (Other)

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Atopic dermatitis - Perspectives and unmet medical needs. [2023]

2. United States 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. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

New and Emerging Therapies for Pediatric Atopic Dermatitis. [2022]

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

New and Potential Treatments for Atopic Dermatitis: Biologicals and Small Molecules. [2020]

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

Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The effect of topically applied corticosteroids on interleukin 1β levels in patients with atopic dermatitis. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

New and emerging trends in the treatment of atopic dermatitis. [2021]

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

Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. [2022]