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Monoclonal Antibodies
BSI-045B + Dupilumab for Eczema (ADAMANT Trial)
Phase 2
Recruiting
Led By James Appel, MD
Research Sponsored by Biosion, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A male patient who is non-sterilized and sexually active with a female partner of childbearing potential, and female patient of childbearing potential who is sexually active with a non-sterilized male partner agrees to use highly effective contraception from the time of signing the ICF throughout the duration of the study and for 90 days (~5 half lives) after the last dose of study drug.
The patient is aged 18 to 65 years, inclusive at the time of consent. Patients of any gender are eligible.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 37
Awards & highlights
ADAMANT Trial Summary
This trial will evaluate a new treatment for moderate to severe eczema/atopic dermatitis, using different doses of a drug, either alone or with another drug.
Who is the study for?
Adults aged 18-65 with moderate to severe atopic dermatitis (AD) can join this trial. They must have an Eczema Area and Severity Index (EASI) score of ≥12, affected body surface area (BSA) ≥10%, and an Investigator's Global Assessment (IGA) score of ≥3. Participants should agree to use effective contraception if applicable. Those on stable dupilumab therapy but still with active AD may also qualify for add-on therapy cohorts.Check my eligibility
What is being tested?
The study tests BSI-045B as a solo treatment or alongside dupilumab in people with AD. It has four groups: two will receive different doses of BSI-045B alone, and two will get these doses plus ongoing dupilumab treatment. The drug is given weekly for three weeks, then every other week up to Week 24.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, general discomfort, potential immune system responses leading to inflammation or allergic reactions, fatigue, and issues related to skin conditions worsening.
ADAMANT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use effective birth control during and 90 days after the study.
Select...
I am between 18 and 65 years old.
Select...
At least 10% of my skin is affected by my condition.
ADAMANT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 37
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 37
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with EASI75 (Eczema Area and Severity Index 75) at Week 12
Safety profile of study treatment
Secondary outcome measures
Immunogenicity
PD/biomarkers
Pharmacokinetic parameters
Other outcome measures
Exploratory endpoint, EASI reduction at week 12
Exploratory endpoint, EASI reduction at week 24
Exploratory endpoint, IGA improvement
+4 moreADAMANT Trial Design
4Treatment groups
Experimental Treatment
Group I: 480 mg Monotherapy CohortExperimental Treatment1 Intervention
BSI-045B 480 mg SC QW × 3 weeks, then BSI-045B 480 mg SC Q2W through Week 24
Group II: 480 mg Add-on Therapy CohortExperimental Treatment2 Interventions
BSI-045B 480 mg SC QW × 3 weeks, then BSI-045B 480 mg SC Q2W through Week 24; to be administered concomitantly with steady-state dupilumab
Group III: 300 mg Monotherapy CohortExperimental Treatment1 Intervention
BSI-045B 300 mg SC QW × 3 weeks, then BSI-045B 300 mg SC Q2W through Week 24
Group IV: 300 mg Add-on Therapy CohortExperimental Treatment2 Interventions
BSI-045B 300 mg SC QW × 3 weeks, then BSI-045B 300 mg SC Q2W through Week 24; to be administered concomitantly with steady-state dupilumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BSI-045B
2021
Completed Phase 1
~60
Dupilumab
2017
Completed Phase 4
~12230
Find a Location
Who is running the clinical trial?
Biosion, Inc.Lead Sponsor
1 Previous Clinical Trials
54 Total Patients Enrolled
James Appel, MDPrincipal Investigatorwilmington health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a serious infection within the last month.I have a skin condition that could affect my eczema diagnosis or treatment.Your skin condition is rated as moderate or severe on the IGA scale during screening and on day 1.I am currently detained for medical or psychiatric reasons.I do not plan to use any prohibited medications or undergo prohibited procedures during the study.I have active disease despite treatment or haven't received any treatment.I agree to use effective birth control during and 90 days after the study.I understand and can follow the study's requirements.Your EASI score is 12 or higher during screening and on day 1.I am between 18 and 65 years old.You have a risk of wanting to harm yourself on purpose.I have a health condition that could make the study unsafe for me or affect the results.You had a severe allergic reaction after receiving a biologic treatment in the past.At least 10% of my skin is affected by my condition.You have a positive test for certain contagious diseases.The patient's ECG readings show specific irregularities.You have had certain nerve-related problems in the past.I am a male and plan to donate sperm during or within 90 days after the study.I have had cancer before, but it might still be okay for me to join.I have difficulty with needle insertions due to poor vein access.I have not donated or lost more than 450 mL of blood, nor had a transfusion in the last 90 days.Your blood pressure or heart rate readings are not within the normal range.My recent blood tests show abnormal liver, kidney, or blood cell levels.I was diagnosed with a worm infection in the last 6 months.I have not had major surgery or dental work in the last 8 weeks.I have been diagnosed with AD for over a year and it has been active for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: 300 mg Add-on Therapy Cohort
- Group 2: 480 mg Add-on Therapy Cohort
- Group 3: 300 mg Monotherapy Cohort
- Group 4: 480 mg Monotherapy Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any eligibility requirements for participating in this clinical research?
"Eligible applicants must demonstrate signs of atopic dermatitis, be over 18 years old, and under 65. Only 80 individuals will be able to participate in this clinical trial."
Answered by AI
Is the research study open to participants of a senior age?
"This clinical trial is looking for individuals aged 18-65."
Answered by AI
Has the 300 mg Monotherapy Cohort gained regulatory approval from the Federal Drug Administration?
"The safety of 300 mg Monotherapy Cohort was judged to be a 2 due to the limited efficacy data available for this Phase 2 trial."
Answered by AI
Is recruitment still available for this clinical trial?
"Data on clinicaltrials.gov reveals that this trial, initially posted on July 24th 2023 and last updated June 27th 2023, is no longer welcoming participants. Nevertheless, there are a plethora of other trials actively recruiting at the present time with over 228 studies in total."
Answered by AI
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