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UCB1381 for Atopic Dermatitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Up0110 103, Seminole, FLAtopic DermatitisUCB1381 - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, UCB1381, for safety and effectiveness in people with atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Zabedosertib
1
ADX-629
1
ASLAN004

Study Objectives

5 Primary · 12 Secondary · Reporting Duration: From Baseline up to Week 22 in Part B

Week 12
Incidents of treatment-emergent adverse events (TEAEs) from Baseline through the End of Study (EOS) Visit (Week 12) in Part A
Incidents of treatment-emergent serious adverse events (TESAEs) from Baseline through the EOS Visit (Week 12) in Part A
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
UCB1381 Cmax from Baseline through the EOS Visit (Week 12) in Part A
UCB1381 F% from Baseline through the EOS Visit (Week 12) in Part A
UCB1381 Tmax from Baseline through the EOS Visit (Week 12) in Part A
Week 12
Percent change from Baseline in EASI score at Week 12 in Part B
UCB1381 AUCtau at week 12 after the final dose in Part B
UCB1381 Cmax at week 12 after the final dose in Part B
UCB1381 Tmax at week 12 after the final dose in Part B
Validated Investigator Global Assessment (vIGA) score of 0 or 1 (Y/N) at Week 12 in Part B
≥50% improvements vs Baseline (Yes/No) in EASI score (EASI50) at Week 12 in Part B
≥75% improvement vs Baseline (Yes/No) in Eczema Area and Severity Index score (EASI75) at Week 12 in Part B
≥90% improvements vs Baseline (Y/N) in EASI score (EASI90) at Week 12 in Part B
Week 22
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

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
Zabedosertib
2
ADX-629
2
ASLAN004

Trial Design

12 Treatment Groups

UCB1381 dosing regime 4 in Part A
1 of 12
UCB1381 dosing regime 6 in Part A
1 of 12
UCB1381 dosing regime 1 in Part A
1 of 12
UCB1381 dosing regime 2 in Part A
1 of 12
UCB1381 dosing regime 3 in Part A
1 of 12
UCB1381 dosing regime 7 in Part A
1 of 12
UCB1381 dosing regime 5 in Part A
1 of 12
UCB1381 dosing regime 8 in Part A
1 of 12
UCB1381 dosing regime 9 in Part B
1 of 12
Placebo sc Arm Part A
1 of 12
Placebo iv Arm Part A
1 of 12
Placebo iv Arm Part B
1 of 12

Experimental Treatment

Non-Treatment Group

152 Total Participants · 12 Treatment Groups

Primary Treatment: UCB1381 · Has Placebo Group · Phase 1 & 2

UCB1381 dosing regime 4 in Part A
Biological
Experimental Group · 1 Intervention: UCB1381 · Intervention Types: Biological
UCB1381 dosing regime 6 in Part A
Biological
Experimental Group · 1 Intervention: UCB1381 · Intervention Types: Biological
UCB1381 dosing regime 1 in Part A
Biological
Experimental Group · 1 Intervention: UCB1381 · Intervention Types: Biological
UCB1381 dosing regime 2 in Part A
Biological
Experimental Group · 1 Intervention: UCB1381 · Intervention Types: Biological
UCB1381 dosing regime 3 in Part A
Biological
Experimental Group · 1 Intervention: UCB1381 · Intervention Types: Biological
UCB1381 dosing regime 7 in Part A
Biological
Experimental Group · 1 Intervention: UCB1381 · Intervention Types: Biological
UCB1381 dosing regime 5 in Part A
Biological
Experimental Group · 1 Intervention: UCB1381 · Intervention Types: Biological
UCB1381 dosing regime 8 in Part A
Biological
Experimental Group · 1 Intervention: UCB1381 · Intervention Types: Biological
UCB1381 dosing regime 9 in Part B
Biological
Experimental Group · 1 Intervention: UCB1381 · Intervention Types: Biological
Placebo sc Arm Part A
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo iv Arm Part A
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo iv Arm Part B
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline up to week 22 in part b

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
85 Previous Clinical Trials
20,672 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273 (UCB)
189 Previous Clinical Trials
43,558 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have moderate to severe Atopic dermatitis (eczema) and are between 18 and 65 years old when you sign the consent form.
Your skin condition has a severity score of 3 or more, based on the evaluation of the doctor.
Your eczema skin condition is severe, with scores of at least 14 during screening and 16 at the start of the trial.
You have severe itching, rated 3 or higher on a scale.
This part of the study is looking for people who are generally healthy and do not have any medical conditions.
You must be between 18-55 years old when you sign the informed consent form.
You must be in good health according to medical tests and evaluations.
Your body mass index (BMI) falls between 18 and 30 kg/m2.
You can be a man or a woman but you need to agree to use birth control during the study.
You have Atopic Dermatitis (AtD) that involves at least 10% of your body surface area during screening and baseline.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Up0110 101100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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