This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD).

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Status and phase

Enrolling
Phase 2

Conditions

Atopic Dermatitis Eczema

Treatments

Drug: ANB032
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05935085
ANB032-201

Details and patient eligibility

About

This study will evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate to severe atopic dermatitis (AD).

Full description

This is a Phase 2, randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of ANB032 in subjects with moderate to severe atopic dermatitis (AD).

Enrollment

160 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Male or female aged 18 to 65 years and in good general health
  • Moderate to severe AD for at least 6 months prior to Randomization
  • History of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable
  • EASI score ≥ 16 at Screening and at Randomization
  • vIGA AD score ≥ 3 at Screening and at Randomization
  • AD involved BSA ≥ 10% at Screening and at Randomization

Key Exclusion Criteria:

  • Any factors that in the Investigator's opinion would predispose the subject to develop an infection
  • Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status
  • Not able to tolerate SC drug administration
  • Tanning booth use or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks before Randomization

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

160 participants in 4 patient groups, including a placebo group

ANB032 SC Dose 1
Experimental group
Description:
This arm will receive treatment SC
Treatment:
Drug: ANB032
ANB032 SC Dose 2
Experimental group
Description:
This arm will receive treatment SC
Treatment:
Drug: ANB032
ANB032 SC Dose 3
Experimental group
Description:
This arm will receive treatment SC
Treatment:
Drug: ANB032
Placebo
Placebo Comparator group
Description:
This arm will receive Placebo SC
Treatment:
Drug: Placebo

Trial contacts and locations

78

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Central trial contact

Aaron Ilan

Data sourced from clinicaltrials.gov

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