Testing ATTO-3712 safety and how it behaves in adults with and without atopic dermatitis

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single Ascending Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ATTO-3712 in Healthy Adult Volunteers and Patients With Atopic Dermatitis

This test will check if ATTO-3712 is safe and how long it stays in the body for healthy adults and adults with atopic dermatitis.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Attovia Therapeutics Inc (industry)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT07205081 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, placebo-controlled, three-part study gives single and multiple ascending doses of ATTO-3712 to healthy adults (Parts 1 and 2) to characterize safety, tolerability, and pharmacokinetics, and multiple doses to adults with active atopic dermatitis in Part 3 to assess safety, PK, and pharmacodynamics using blood biomarkers. Participants are randomized to receive ATTO-3712 or matching placebo, attend clinic visits for dosing, monitoring, and sample collection, and keep daily symptom diaries. Dose escalation in healthy volunteers precedes patient dosing to identify tolerated dose levels, and patient eligibility and disease status are defined using measures such as EASI, vIGA-AD, and PP-NRS. Safety monitoring includes vital signs, ECGs, clinical labs, and adverse event reporting throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with moderate-to-severe atopic dermatitis (EASI ≥16, vIGA-AD ≥3, PP-NRS ≥4, ≥10% BSA) who have had inadequate response to topical therapies and can attend the Montreal clinic.

Not a fit: People with mild AD who do not meet the severity criteria, those outside the specified age or BMI ranges, pregnant people, or individuals unable to attend required clinic visits and sampling are unlikely to receive benefit from this Phase 1 dosing study.

Why it matters

Potential benefit: If successful, ATTO-3712 could lead to a new treatment option that reduces symptoms and improves skin disease for people with atopic dermatitis.

How similar studies have performed: The single- and multiple-ascending-dose PK/safety design is standard for first-in-human programs; while other novel systemic agents for AD have shown benefit in later trials, ATTO-3712 itself is unproven in patients.

Eligibility criteria

Parts 1\&2 (Healthy Volunteers) Key Inclusion Criteria:

* Any sex or gender who is 18 to 65 years old, inclusive, at Screening.
* Body weight of 50 to 125 kg and body mass index (BMI) between 18.5 and 35 kg/m2
* Considered in good general health based on medical history, physical exam, 12-lead ECG, screening clinical laboratory findings, and vital signs
* Negative pregnancy test for participants of child-bearing potential.

Part 3 (Participants with Atopic Dermatitis) Key Inclusion Criteria:

* Any sex or gender who is 18 to 65 years old
* Body weight of 50 to 125 kg and BMI between 18.5 and 40 kg/m2
* Clinically confirmed diagnosis of active AD
* History of inadequate response to treatment with topical medications
* Baseline weekly mean of daily PP-NRS ≥ 4 at Day 1.
* EASI score of ≥ 16 at Screening and Day 1
* vIGA-AD score of ≥ 3 at Screening and Day 1
* ≥10% of body surface area (BSA) affected by AD at Screening and Day 1
* Use of topical bland emollient (moisturizer) at least once daily for at least 5 of the 7 days immediately before Day 1 and agrees to continue using that same emollient at the same frequency throughout the study
* Negative pregnancy test for participants of childbearing potential

Parts 1 \& 2 (Healthy Volunteers) Key Exclusion Criteria

* Any clinically significant underlying illness
* History of malignancy within 5 years of Screening
* History of major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study
* History of uncontrolled asthma requiring rescue treatment with a bronchodilator for an increase in symptoms more than twice per week
* History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients (sucrose, polysorbate 80, or histidine)
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or is positive for HIV
* Active or latent tuberculosis infection
* Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day
* History of drug or alcohol abuse
* Laboratory values outside of the normal range

Part 3 (Participants with Atopic Dermatitis) Key Exclusion Criteria:

* Any clinically significant underlying illness
* Presence of skin comorbidities that may interfere with study assessments
* Has taken prescription medication for the treatment of AD or other prohibited medication within the restricted time limits (defined in the protocol)
* Has applied topical corticosteroids within 2 weeks prior to dosing.
* History of malignancy within 5 years of Screening
* History of major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study
* History of uncontrolled asthma requiring rescue treatment with a bronchodilator for an increase in symptoms more than twice per week
* History of recurrent eczema herpeticum
* History of known primary immunodeficiency, is considered immunocompromised, history of untreated latent tuberculosis infection, has been treated for active tuberculosis in the past year, or has been treated for a parasitic infection in the past 6 months
* History of major depression
* History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients (sucrose, polysorbate 80, or histidine)
* Participant has experienced significant flare(s) in AD in the 2 weeks prior to Screening or during the Screening period
* EASI score for the participant has more than doubled between Screening and Day 1
* Active HBV or HCV or is positive for HIV
* Participant is smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent to approximately 40 mg nicotine) per day
* Participant has an ECG with a QTcF \> 450 msec for males or \> 470 msec for females at Screening
* History of drug or alcohol abuse
* Laboratory values outside of the normal range

Where this trial is running

Montreal, Quebec

• Altasciences — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: Malinda Longphre, PhD

Conditions: Normal Volunteers, Atopic Dermatitis, Atopic Eczema, Atopic Eczema/Dermatitis, AD, Ecema, Itch, Pruritus