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Monoclonal Antibodies

ANB032 for Eczema

Phase 2

Recruiting

Research Sponsored by AnaptysBio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

AD involved BSA ≥ 10% at Screening and at Randomization

History of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 14

Awards & highlights

Study Summary

This trial will test a new drug to help people with moderate to severe eczema, to see how safe and effective it is.

Who is the study for?

Adults aged 18-65 with moderate to severe atopic dermatitis (AD) for at least 6 months, who haven't responded well to topical treatments or can't use them. Participants must have certain scores on AD severity scales and at least 10% of their body surface area affected.Check my eligibility

What is being tested?

The trial is testing ANB032 against a placebo to see if it's safe, tolerable, and effective in treating AD. Patients will be randomly assigned to receive either the actual drug or a placebo without knowing which one they're getting.See study design

What are the potential side effects?

Specific side effects are not listed but generally could include reactions at the injection site, potential immune system changes due to the nature of the drug being tested, and other unforeseen responses related to safety and tolerability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My skin condition affects more than 10% of my body.

Select...

Topical treatments for my skin condition were ineffective or not recommended for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change from Baseline in EASI at Week 14

Secondary outcome measures

Mean percent change from Baseline in EASI at Week 14

Proportion of subjects who achieve a vIGA-AD score of 0 or 1 and ≥ 2-point reduction (improvement) from Baseline in vIGA-AD score at Week 14

Proportion of subjects who achieve ≥ 75% reduction (improvement) from Baseline in EASI-75 at Week 14

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: ANB032 SC Dose 3Experimental Treatment1 Intervention

This arm will receive treatment SC

Group II: ANB032 SC Dose 2Experimental Treatment1 Intervention

This arm will receive treatment SC

Group III: ANB032 SC Dose 1Experimental Treatment1 Intervention

This arm will receive treatment SC

Group IV: PlaceboPlacebo Group1 Intervention

This arm will receive Placebo SC

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AnaptysBio, Inc.Lead Sponsor

16 Previous Clinical Trials

1,488 Total Patients Enrolled

Mark Rigby, MDStudy DirectorAnaptysBio, Inc.

1 Previous Clinical Trials

209 Total Patients Enrolled

Jocelyne Papacharalambous, MDStudy DirectorAnaptysBio, Inc.

Media Library

ANB032 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05935085 — Phase 2

Atopic Dermatitis Research Study Groups: ANB032 SC Dose 1, ANB032 SC Dose 2, ANB032 SC Dose 3, Placebo

Atopic Dermatitis Clinical Trial 2023: ANB032 Highlights & Side Effects. Trial Name: NCT05935085 — Phase 2

ANB032 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05935085 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment criteria for this experiment including those over eighty-five years of age?

"This clinical trial has set 18 as the lower limit of age eligibility and 65 as its upper cap."

Answered by AI

How many participants can the current research accommodate?

"Indeed, the clinicaltrials.gov website provides evidence that this trial is still actively recruiting individuals, having initially been posted on June 13th 2023 and recently updated on July 5th 2023. The recruitment necessitates 160 patients from 28 distinct sites."

Answered by AI

Could I potentially be admitted into this experiment?

"The criteria for acceptance into this clinical trial requires that participants have atopic dermatitis and are between 18-65 years of age. This medical study is actively recruiting a total of 160 individuals."

Answered by AI

Is this scientific experiment recruiting participants at the present time?

"Affirmative. The clinical trial details published on clinicaltrials.gov suggest that this medical study, which was posted in June of 2023 and last updated in July, is actively searching for participants. 160 patients need to be enrolled from 28 different sites."

Answered by AI

Has ANB032 SC Dose 1 successfully passed regulatory scrutiny from the FDA?

"Our assessment of ANB032 SC Dose 1's safety is a 2 due to the lack of clinical data supporting its efficacy, though there are numerous reports that suggest it is secure."

Answered by AI

How many research sites are administering this experiment?

"Patients can join this medical trial at Center For Dermatology Clinical Research Inc. in Fremont, Florida, Antelope Valley Clinical Trials in Lancaster, Georgia, and Torrance Clinical Research Institute Inc. in Lomita Kentucky as well as 28 additional sites around the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05935085.

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