← Back to Search

Monoclonal Antibodies

BxC-I17e for Eczema

Phase 1

Recruiting

Research Sponsored by Brexogen Inc.

Eligibility Criteria Checklist

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

Must have

Patients have documented history of moderate to severe AD, that has been present for at least 1 year

History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 26

Awards & highlights

Study Summary

This trial tests a new treatment for moderate to severe eczema, to see if it's safe and has any positive effects.

Who is the study for?

Adults over 18 with moderate to severe atopic dermatitis (AD) for at least a year, who haven't responded well to standard creams or ointments. They must use fragrance-free moisturizers twice daily for a week before starting and be able to follow the study plan. Pregnant or breastfeeding women, those in other studies, with serious health issues, certain blood/lab abnormalities, HIV, or recent AD treatments are excluded.Check my eligibility

What is being tested?

The trial is testing BxC-I17e's safety and effectiveness against a placebo in one-time subcutaneous injections for people with stubborn eczema. It aims to see if this new treatment can help when regular therapies don't work.See study design

What are the potential side effects?

While specific side effects of BxC-I17e aren't listed here, common ones from similar treatments include injection site reactions, potential immune system changes leading to increased infection risk or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have had moderate to severe atopic dermatitis for at least 1 year.

Select...

I have tried treatments for my skin condition without success.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 26 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of treatment-emergent adverse events (TEAEs)

Secondary outcome measures

Change and percent change in Body Surface Area (BSA)

Change and percent change in Dermatology Life Quality Index (DLQI)

Change and percent change in Eczema Area and Severity Index (EASI)

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BxC-I17eExperimental Treatment1 Intervention

Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e Single dose on Day 1

Group II: PlaceboPlacebo Group1 Intervention

Subcutaneous (SC) injection of the matching placebo Single dose on Day 1

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brexogen Inc.Lead Sponsor

1 Previous Clinical Trials

18 Total Patients Enrolled

Frequently Asked Questions

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

What risks might individuals face when exposed to BxC-I17e?

"The safety score assigned to BxC-I17e was a 1 due to its current status in Phase 1 trials indicating limited evidence of efficacy and safety."

Answered by AI

What is the cap on how many persons are participating in this clinical trial?

"Affirmative. Data hosted on clinicaltrials.gov corroborates that this medical trial, originally posted April 18th 2023, is currently recruiting for participation. 27 individuals are needed from 3 separate sites."

Answered by AI

Are there any vacancies within this research endeavor for participants?

"Affirmative. According to clinicaltrials.gov, this trial which was inaugurated on April 18th 2023 is still enrolling patients and was recently updated on September 20th 2023. 27 participants need to be recruited from 3 medical centres across the country."

Answered by AI