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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)
Part A Healthy study participants must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to week 22 in part b
Awards & highlights
Study Summary
This trial is testing a new drug, UCB1381, for safety and effectiveness in people with atopic dermatitis.
Who is the study for?
This trial is for healthy adults aged 18-55 with a BMI of 18-30 kg/m2, and adults aged 18-65 with moderate to severe atopic dermatitis (AD), a BMI of 18-35 kg/m2, and certain severity scores. Participants must not have used specific treatments recently or have conditions that could affect the study.Check my eligibility
What is being tested?
The safety and effects of UCB1381 are being tested in two parts: Part A tests single doses on healthy participants; Part B tests repeated doses on those with AD compared to placebo. The focus is on how well it works for AD after multiple doses.See study design
What are the potential side effects?
While the side effects aren't specified here, common ones for new drugs like UCB1381 might include reactions at injection sites, fatigue, headaches, or allergic responses. More details would be provided by the study team.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
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I am between 18 and 55 years old and can sign a consent form.
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I have had severe skin eczema for over a year, not better with usual creams.
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I have moderate to severe Atopic dermatitis and my BMI is between 18 and 35.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to week 22 in part b
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to week 22 in part b
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidents of TEAEs from Baseline through the EOS Visit (Week 22) in Part B
Incidents of TESAEs from Baseline through the EOS Visit (Week 22) in Part B
Incidents of treatment-emergent adverse events (TEAEs) from Baseline through the End of Study (EOS) Visit (Week 12) in Part A
+2 moreSecondary outcome measures
Percent change from Baseline in EASI score at Week 12 in Part B
UCB1381 AUC from Baseline through the EOS Visit (Week 12) in Part A
UCB1381 AUC(0-t) from Baseline through the EOS Visit (Week 12) in Part A
+9 moreTrial Design
12Treatment groups
Experimental Treatment
Placebo Group
Group I: UCB1381 dosing regime 9 in Part BExperimental Treatment1 Intervention
Participants will be randomized to receive repeated doses UCB1381 intravenously (iv).
Group II: UCB1381 dosing regime 8 in Part AExperimental Treatment1 Intervention
Participants will be randomized to receive a single dose UCB1381 intravenously (iv).
Group III: UCB1381 dosing regime 7 in Part AExperimental Treatment1 Intervention
Participants will be randomized to receive a single dose UCB1381 intravenously (iv).
Group IV: UCB1381 dosing regime 6 in Part AExperimental Treatment1 Intervention
Participants will be randomized to receive a single dose UCB1381 subcutaneously (sc).
Group V: UCB1381 dosing regime 5 in Part AExperimental Treatment1 Intervention
Participants will be randomized to receive a single dose UCB1381 subcutaneously (sc).
Group VI: UCB1381 dosing regime 4 in Part AExperimental Treatment1 Intervention
Participants will be randomized to receive a single dose UCB1381 intravenously (iv).
Group VII: UCB1381 dosing regime 3 in Part AExperimental Treatment1 Intervention
Participants will be randomized to receive a single dose UCB1381 intravenously (iv).
Group VIII: UCB1381 dosing regime 2 in Part AExperimental Treatment1 Intervention
Participants will be randomized to receive a single dose UCB1381 intravenously (iv).
Group IX: UCB1381 dosing regime 1 in Part AExperimental Treatment1 Intervention
Participants will be randomized to receive a single dose UCB1381 intravenously (iv).
Group X: Placebo iv Arm Part APlacebo Group1 Intervention
Participants will be randomized to receive a single dose of placebo iv to maintain the blinding.
Group XI: Placebo sc Arm Part APlacebo Group1 Intervention
Participants will be randomized to receive a single dose of placebo sc to maintain the blinding.
Group XII: Placebo iv Arm Part BPlacebo Group1 Intervention
Participants will be randomized to receive repeated doses of placebo iv to maintain the blinding.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
102 Previous Clinical Trials
21,451 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273 (UCB)
205 Previous Clinical Trials
44,811 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is between 18 and 30.I have moderate to severe Atopic dermatitis and haven't been in studies for IL-13 or IL-22 or JAK inhibitors recently.I haven't taken any medication for my severe skin condition or other treatments, except for certain allowed ones, in the last 14 days.I have had severe skin eczema for over a year, not better with usual creams.I haven't used certain medications or treatments for my severe skin condition in the last 4 weeks.I agree to use birth control during the study.I haven't been in another drug study or taken biologic agents in the last 30 days or 5 half-lives.I am healthy and agree to use birth control.This part of the study is looking for people who are generally healthy and do not have any medical conditions.I am healthy based on recent medical exams, lab tests, and heart checks.I have never had inflammatory bowel disease, including Crohn's or ulcerative colitis.Healthy study participants must have a body mass index (BMI) between 18 and 30.I am between 18 and 55 years old and can sign a consent form.I have no allergies to medications or severe reactions to drugs.I have moderate to severe Atopic dermatitis and haven't used specific biologics or JAK inhibitors recently.I am generally healthy as confirmed by recent medical exams and tests.I am between 18 and 65 years old with moderate to severe Atopic dermatitis.I am between 18 and 55 years old.I am between 18 and 65 years old with moderate to severe atopic dermatitis.I have moderate to severe Atopic dermatitis and no history of inflammatory bowel disease.I have moderate to severe Atopic dermatitis and my BMI is between 18 and 35.I have moderate to severe Atopic dermatitis without allergies to the trial drug or similar treatments.I am healthy with no medical or psychiatric conditions that could affect the study.I haven't used any prescription skin treatments for my severe eczema in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: UCB1381 dosing regime 3 in Part A
- Group 2: Placebo iv Arm Part A
- Group 3: UCB1381 dosing regime 1 in Part A
- Group 4: UCB1381 dosing regime 4 in Part A
- Group 5: UCB1381 dosing regime 9 in Part B
- Group 6: UCB1381 dosing regime 2 in Part A
- Group 7: Placebo sc Arm Part A
- Group 8: Placebo iv Arm Part B
- Group 9: UCB1381 dosing regime 5 in Part A
- Group 10: UCB1381 dosing regime 6 in Part A
- Group 11: UCB1381 dosing regime 7 in Part A
- Group 12: UCB1381 dosing regime 8 in Part A
Awards:
This trial has 0 awards, including: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.
Under what qualifications can one partake in this experiment?
"This clinical trial is actively recruiting 152 patients aged 18 to 65 with moderate to severe eczema. The inclusion criteria for this study necessitates that these individuals must be healthy according to medical history, physical examination and laboratory testing results; have a BMI between 18-30 kg/m2; agree to contraceptive use if applicable; present an Investigator Global Assessment (vIGA) score of at least 3 at both Screening and Baseline assessments, along with an Eczema Area and Severity Index (EASI) rating of ≥14 during screening and ≥16 at the baseline assessment. Additionally, participants should exhibit pruritus severity"
Answered by AI
What key aims does this experiment seek to accomplish?
"The primary aim of this 12-week program is to compare the magnitude of improvement in Eczema Area and Severity Index (EASI75) scores against baseline. Secondary goals include assessing UCB1381 Tmax, AUC(0-t),and Cmax at Week 12 after final dose administration in Part B."
Answered by AI
Does this trial have age restrictions, and if so, what are they?
"As per the requirements of this medical experiment, prospective participants must be above 18 years old and below 65."
Answered by AI
Are there available vacancies in this experiment for participants?
"As documented on clinicaltrials.gov, this trial is open to recruitment with the initial posting having been made on March 7th 2022 and edited as recently as July 20th 2022."
Answered by AI
What is the current number of participants in this investigation?
"Indeed, the clinical trial is actively enrolling participants. The initial posting was on March 7th 2022 and it has been revised as recently as July 20th 2022. This study seeks to recruit 152 individuals from a single medical site."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Up0110 101
Up0110 120
What portion of applicants met pre-screening criteria?
Met criteria
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