Efficacy, Safety, and Pharmacokinetic Profile of ANB020 in Adults with Moderate to Severe Atopic Dermatitis

Phase 1

• Conditions: Moderate-to-Severe Atopic Dermatitis; MedDRA version: 20.0Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-000331-27-PL
• Lead Sponsor: AnaptysBio Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-25
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

? Male or female subjects must be 18 to 75 years of age, at the time of signing the informed consent.
? Body mass index (BMI) of 18 to 35 kg/m2 for females and 18 to 40 kg/m2 for males, and total body weight >50 kg (110 lb).
? Clinically confirmed diagnosis of AD.
? Eczema Area and Severity Index (EASI) score =16, body surface area (BSA) involvement =10%, and an Investigator’s Global Assessment (IGA) score (5-point scale) =3 at Baseline.
? Subjects with a history of inadequate response to topical treatment, use of systemic treatments to treat AD, and/or for whom topical treatments are otherwise medically inadvisable.
? Daily use of non-medicated emollient for at least 7 days prior to Baseline.
? A WOCB who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after receiving the last dose of study treatment and refrain donating oocytes (eggs)during this period.
For additional details refer to the study protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 285
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

? Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing.
? Prior exposure to an anti-IL-33 antibody.
? Exposure to an investigational or licensed or other anti-Th2-type cytokine or cytokine receptor antagonist within 16 weeks or 5 half-lives, whichever is longer.
? History of prior exposure to any investigational or biologic systemic treatment within 5 half-lives of the screening or is currently enrolled in another clinical study.
? Have received systemic treatment for AD (including systemic corticosteroids, immunosuppressants or immunomodulating drugs, or phototherapy or use of a tanning booth) within 4 weeks before screening.
? History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified