72 Participants Needed

ATTO-3712 for Atopic Dermatitis

ML
Overseen ByMalinda Longphre, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Attovia Therapeutics Inc
Must be taking: Topical emollients

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ATTO-3712 for individuals with atopic dermatitis, commonly known as eczema. The researchers aim to assess the safety of ATTO-3712, how the body responds to it, and its duration in the system compared to a placebo. Participants with active eczema who have not found relief with creams or ointments might be suitable candidates. During the trial, participants will receive either the treatment or a placebo, visit the clinic for checkups, and monitor any symptoms. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not clearly specify if you need to stop taking your current medications. However, it mentions that participants with atopic dermatitis should not have taken prescription medication for AD or applied topical corticosteroids within certain time limits before the study. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that ATTO-3712 is likely to be safe for humans?

Previous studies have tested ATTO-3712 for safety and tolerance. Research shows that both the IV (intravenous, directly into the bloodstream) and SC (subcutaneous, under the skin) forms of ATTO-3712 have been used in healthy adults and people with atopic dermatitis. Although detailed safety data from these studies is unavailable, the treatment's early trial phase means researchers focus primarily on ensuring its safety for humans.

Early trials may provide limited information on side effects, but serious issues would likely halt further testing. ATTO-3712 is a new treatment designed to reduce skin inflammation and itchiness by targeting specific proteins in the body. This method resembles other treatments already used for skin conditions, offering some hope for its safety. However, by participating in a trial, participants help determine the exact safety and effectiveness of this new treatment.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about ATTO-3712 for atopic dermatitis because it offers a potentially new way to manage this skin condition. Unlike the standard treatments, which often include topical steroids or calcineurin inhibitors, ATTO-3712 can be administered via intravenous (IV) or subcutaneous (SC) injections, providing flexibility in treatment options. Additionally, ATTO-3712 has a novel mechanism of action that targets specific pathways involved in inflammation, which might lead to more effective control of symptoms with fewer side effects. This innovative approach could significantly improve the quality of life for those struggling with atopic dermatitis.

What evidence suggests that ATTO-3712 might be an effective treatment for atopic dermatitis?

Research has shown that ATTO-3712 could be a promising treatment for atopic dermatitis, a type of eczema. It targets two specific proteins that cause skin inflammation and itchiness. Early studies suggest this approach may effectively reduce symptoms like redness and itching. Although human studies have provided limited information, these results offer hope for those seeking new eczema treatments. In this trial, participants will receive either a single or multiple doses of ATTO-3712, administered intravenously or subcutaneously, or a placebo. Ongoing research focuses on understanding its safety and the duration of its activity in the body.14567

Are You a Good Fit for This Trial?

This trial is for healthy adults and those with atopic dermatitis, a type of eczema that causes itchy and inflamed skin. Participants must meet certain health standards to join. Specific details on who can or cannot participate are not provided here.

Inclusion Criteria

Healthy Volunteers: Negative pregnancy test for participants of child-bearing potential
I am a healthy volunteer aged 18 to 65.
I weigh between 50 and 125 kg and my BMI is between 18.5 and 35.
See 11 more

Exclusion Criteria

Healthy Volunteers: Laboratory values outside of the normal range
Healthy Volunteers: Any clinically significant underlying illness
Healthy Volunteers: History of hypersensitivity to biologic medications, vaccines, or IP excipients
See 12 more

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-3712 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-3712 or placebo to assess safety, tolerability, pharmacokinetics, and pharmacodynamics

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-3712
Trial Overview The study tests ATTO-3712's safety, how well it's tolerated by the body, and how long it stays in the system compared to a placebo (a substance with no active drug). Participants will receive either ATTO-3712 or placebo, undergo checkups and testing, and record their symptoms.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Placebo Group
Group I: ATTO-3712 single dose SCExperimental Treatment1 Intervention
Group II: ATTO-3712 single dose IVExperimental Treatment1 Intervention
Group III: ATTO-3712 multiple dose SCExperimental Treatment1 Intervention
Group IV: Placebo single dose IVPlacebo Group1 Intervention
Group V: Placebo single dose SCPlacebo Group1 Intervention
Group VI: Placebo multiple dose SCPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Attovia Therapeutics Inc

Lead Sponsor

Trials
1
Recruited
100+

Citations

Safety, Tolerability and PK of ATTO-3712 in Healthy ...The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of ATTO-3712 in healthy adults and patients with ...
Safety, Tolerability and PK of ATTO-3712 in Healthy ...International Clinical Trial: Safety, Tolerability and PK of ATTO-3712 in Healthy Volunteers and Patients With Atopic Dermatitis. Posted On ...
ATTO-3712 Clinical Trial for Atopic Dermatitis - ICH GCPClinical trial investigating ATTO-3712 for atopic dermatitis treatment. Study evaluates safety, effectiveness in adults with eczema.
Attovia Building Immune-Mediated Disease Pipeline with ...Attovia says ATTO-3712 will offer efficacy and convenient dosing in atopic dermatitis, the drug's lead indication—and potentially in other ...
Attovia Closes $90 Million Series C Financing for ...These assets will be used to treat chronic pruritus and atopic dermatitis, with hopes of achieving best-in-disease efficacy. The funds will also ...
Normal Volunteers (DBCOND0034656)Safety, Tolerability and PK of ATTO-3712 in Healthy Volunteers and Patients With Atopic Dermatitis. ATTO-3712. treatment, 1, not_yet_recruiting. NCT02860351.
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40993471/
The Safety Data of Dupilumab for the Treatment ...This study reviews the safety of the drug dupilumab, which is used to treat infants, children, adolescents, and adults who have moderate-to- ...
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