The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants with atopic dermatitis. Efficacy will be assessed following repeat intravenous dosing versus placebo in study participants with atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
109
UCB1381 will be administered intravenously (iv) or subcutaneously (sc) in different dosages in Part A and iv in Part B
Placebo will be administered iv or sc in Part A and iv in Part B to maintain the blinding.
Up0110 125
Beverly Hills, California, United States
Up0110 101
Glendale, California, United States
Up0110 116
Los Angeles, California, United States
Up0110 121
Northridge, California, United States
Up0110 126
Tustin, California, United States
Up0110 127
Valencia, California, United States
Up0110 108
Clearwater, Florida, United States
Up0110 109
Miami Lakes, Florida, United States
Up0110 106
Ocala, Florida, United States
Up0110 102
St. Petersburg, Florida, United States
...and 6 more locations
Incidents of treatment-emergent adverse events (TEAEs) from Baseline through the End of Study (EOS) Visit (Week 12) in Part A
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.
Time frame: From Baseline up to Week 12 in Part A
Incidents of treatment-emergent serious adverse events (TESAEs) from Baseline through the EOS Visit (Week 12) in Part A
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Time frame: From Baseline up to Week 12 in Part A
Incidents of TEAEs from Baseline through the EOS Visit (Week 22) in Part B
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.
Time frame: From Baseline up to Week 22 in Part B
Incidents of TESAEs from Baseline through the EOS Visit (Week 22) in Part B
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Time frame: From Baseline up to Week 22 in Part B
≥75% improvement vs Baseline (Yes/No) in Eczema Area and Severity Index score (EASI75) at Week 12 in Part B
The Eczema Area and Severity Index (EASI) is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. A participant's EASI is scored through evaluation of 4 body regions: Head and neck; Trunk; Upper extremities; Lower extremities The severity of disease is evaluated by assessing each of 4 clinical signs for each area: Erythema; Edema/papulation; Excoriation; Lichenification The severity of each clinical sign is scored as: 0=None, 1=Mild, 2=Moderate, 3=Severe.
Time frame: From Baseline up to Week 12 in Part B
UCB1381 Cmax from Baseline through the EOS Visit (Week 12) in Part A
Cmax: Maximum observed concentration
Time frame: From Baseline up to Week 12 in Part A
UCB1381 Tmax from Baseline through the EOS Visit (Week 12) in Part A
Tmax: Time of observed Cmax
Time frame: From Baseline up to Week 12 in Part A
UCB1381 AUC(0-t) from Baseline through the EOS Visit (Week 12) in Part A
AUC(0-t): Area under the concentration-time curve from time zero to the time of last detectable concentration.
Time frame: From Baseline up to Week 12 in Part A
UCB1381 AUC from Baseline through the EOS Visit (Week 12) in Part A
AUC: Area under the concentration-time curve from time zero to infinity.
Time frame: From Baseline up to Week 12 in Part A
UCB1381 F% from Baseline through the EOS Visit (Week 12) in Part A
F%: Bioavailability of subcutaneous administration
Time frame: From Baseline up to Week 12 in Part A
Percent change from Baseline in EASI score at Week 12 in Part B
The Eczema Area and Severity Index (EASI) is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. A participant's EASI is scored through evaluation of 4 body regions: Head and neck; Trunk; Upper extremities; Lower extremities The severity of disease is evaluated by assessing each of 4 clinical signs for each area: Erythema; Edema/papulation; Excoriation; Lichenification The severity of each clinical sign is scored as: 0=None, 1=Mild, 2=Moderate, 3=Severe.
Time frame: From Baseline up to Week 12 in Part B
≥50% improvements vs Baseline (Yes/No) in EASI score (EASI50) at Week 12 in Part B
The Eczema Area and Severity Index (EASI) is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. A participant's EASI is scored through evaluation of 4 body regions: Head and neck; Trunk; Upper extremities; Lower extremities The severity of disease is evaluated by assessing each of 4 clinical signs for each area: Erythema; Edema/papulation; Excoriation; Lichenification The severity of each clinical sign is scored as: 0=None, 1=Mild, 2=Moderate, 3=Severe.
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Time frame: From Baseline up to Week 12 in Part B
≥90% improvements vs Baseline (Y/N) in EASI score (EASI90) at Week 12 in Part B
The Eczema Area and Severity Index (EASI) is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. A participant's EASI is scored through evaluation of 4 body regions: Head and neck; Trunk; Upper extremities; Lower extremities The severity of disease is evaluated by assessing each of 4 clinical signs for each area: Erythema; Edema/papulation; Excoriation; Lichenification The severity of each clinical sign is scored as: 0=None, 1=Mild, 2=Moderate, 3=Severe.
Time frame: From Baseline up to Week 12 in Part B
Validated Investigator Global Assessment (vIGA) score of 0 or 1 (Y/N) at Week 12 in Part B
vIGA: Validated Investigator Global Assessment score is using descriptors that best describe the overall appearance of the lesions at a given time point. Assessment: vIGA 0=clear, vIGA 1=almost clear, vIGA 2=mild, vIGA 3=moderate, vIGA 4=severe
Time frame: From Baseline up to Week 12 in Part B
UCB1381 Cmax at week 12 after the final dose in Part B
Cmax: Maximum observed concentration
Time frame: From Baseline up to Week 12 in Part B
UCB1381 Tmax at week 12 after the final dose in Part B
Tmax: Time of observed Cmax
Time frame: From Baseline up to Week 12 in Part B
UCB1381 AUCtau at week 12 after the final dose in Part B
AUCtau: Area under the curve for the dosing interval after the final dose.
Time frame: From Baseline up to Week 12 in Part B