Safety, Tolerability and PK of ATTO-1310 in Healthy Volunteers and Patients With Atopic Dermatitis and Patients With Chronic Pruritus

Launched by ATTOVIA THERAPEUTICS INC · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called ATTO-1310 to see how safe it is and how well it works for people with atopic dermatitis, a skin condition that causes itchiness and rashes. The study will also examine how long the drug stays in the body after it's taken. Participants in the trial will either receive ATTO-1310 or a placebo (a substance that looks like the drug but has no active ingredients) and will be monitored for any side effects. They'll also keep a diary to track their symptoms.

To join this trial, healthy adults aged 18 to 65 and patients with atopic dermatitis in the same age range may qualify, provided they meet certain health criteria. Healthy volunteers should generally be in good health, while patients must have a confirmed diagnosis of atopic dermatitis and have experienced the condition for at least a year. Throughout the study, participants will visit the clinic for checkups and tests to ensure their safety and to gather important information about the drug. This trial is currently recruiting participants, and both men and women are welcome to apply.

Gender

ALL

Eligibility criteria

• Parts 1 \& 2 (Healthy Volunteers) Key Inclusion Criteria:
• • Any sex or gender who is 18 to 65 years old
• • 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 subjects of child-bearing potential
• • Use of highly effective forms of birth control
• Part 3 (Subjects with Atopic Dermatitis) 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
• • At least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before Screening
• • Baseline weekly mean of daily PP-NRS ≥ 7 at Day 1
• • EASI score of ≥ 7 at Screening and Day 1
• • vIGA-AD score of ≥ 3 at Screening and Day 1
• • Use of topical bland emollient (moisturizer) once or twice 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 subjects of child-bearing potential
• • Use of highly effective forms of birth control
• Part 4 (Subjects with Chronic Pruritus) Inclusion Criteria:
• • Any sex or gender who is 18 to 85 years old
• • Body weight of 50 to 125 kg, inclusive, and BMI between 18.5 and 40 kg/m2
• • Has had chronic pruritus for at least 6 months and is unresponsive to at least a 2-week course of emollient use.
• • Chronic pruritus that affects at least 2 of the following body areas: legs, arms, or trunk
• • A single PP-NRS score of ≥ 5 in the 24-hour period prior to the Screening visit
• • Baseline weekly mean of daily PP-NRS ≥ 7 at Day 1
• • Use of a stable dose of topical bland emollient (moisturizer) once or twice daily for at least 2 weeks before Day 1 and agrees to continue using that same emollient at the same frequency throughout the study
• • Negative pregnancy test for subjects of child-bearing potential
• • Use of highly effective forms of birth control
• Parts 1 \& 2 (Healthy Volunteers) Exclusion Criteria:
• • Any clinically significant underlying illness.
• • History of malignancy within 5 years of Screening, except adequately treated basal carcinoma or in situ carcinoma of the cervix.
• • History of major surgery within 8 weeks prior to Day 1
• • History of asthma requiring regular use of a bronchodilator or a daily maintenance therapy
• • 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
• Exclusion Criteria for Part 3 (Subjects with Atopic Dermatitis):
• • Any clinically significant underlying illness
• • History of a clearly defined etiology for pruritus other than AD, including but not limited to urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection
• • 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 asthma requiring regular use of a bronchodilator or a daily maintenance therapy
• • 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)
• • Active HBV or HCV or is positive for HIV
• • Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day
• • ECG with a QTcF \> 450 msec for males or \> 470 msec for females at Screening
• • History of drug or alcohol abuse
• • Subject has applied topical corticosteroid in the 14 days preceding Day 1
• • Subject has used prohibited medications or therapies during the specified washout period before Day 1 (as defined in the protocol)
• • Laboratory values outside of the normal range
• Exclusion Criteria for Part 4 (Subjects with Chronic Pruritus):
• • Primary dermatologic diagnosis associated with pruritic skin lesions at the time of screening
• • Regional neuropathic disease associated with pruritus
• • Severe renal failure requiring dialysis
• • Untreated cholestatic liver disease
• • Liver function tests (bilirubin, AST, ALT, alkaline phosphatase) \>2.5 times above the upper limit of normal
• • History of infectious dermatoses
• • Suspected diagnosis of somatoform pruritus
• • Suspected diagnosis of drug-induced pruritus
• • History of malignancy within 5 years of Screening
• • History of unexplained fevers, night sweats, or unintentional weight loss
• • Major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study
• • History of asthma requiring regular use of a bronchodilator or a daily maintenance therapy
• • History of known primary immunodeficiency, is considered immunocompromised, 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 attempted suicide
• • 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 HBV or HCV or is positive for HIV.
• • Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day
• • ECG with a QTcF \> 450 msec for males or \> 470 msec for females at Screening
• • History of drug or alcohol abuse
• • Use of prohibited medications as defined in the Protocol