The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB9741 administered by intravenous infusion or subcutaneous injection to healthy study participants and following repeat dosing at a single dose level in study participants with atopic dermatitis. Furthermore, the clinical efficacy outcome in study participants with atopic dermatitis after administration of UCB9741 by intravenous infusion will be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
107
\- Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.
\- Pharmaceutical form: Solution Participants will receive Placebo to maintain the blinding during the Treatment Period.
Pharmaceutical form: Solution Participants will receive subcutaneous Placebo to maintain the blinding during the Treatment Period.
Up0089 303
Pleven, Bulgaria
Up0089 301
Sofia, Bulgaria
Up0089 304
Sofia, Bulgaria
Up0089 407
Berlin, Germany
Incidents of treatment-emergent adverse events (TEAEs) during Part A
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: From Baseline up to the End of Study Visit (Week 12)
Incidents of treatment-emergent serious adverse events (TESAEs) during 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 the End of Study Visit (Week 12)
Incidents of TEAEs during Part B
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: From Baseline up to the End of Study Visit (Week 18)
Incidents of TESAEs during 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Up0089 408
Heidelberg, Germany
Up0089 410
Leipzig, Germany
Up0089 201
Leiden, Netherlands
Up0089 104
Liverpool, United Kingdom
Up0089 101
London, United Kingdom
Up0089 103
Manchester, United Kingdom
Time frame: From Baseline up to the End of Study Visit (Week 18)
≥75% improvement vs Baseline in Eczema Area and Severity Index (EASI75) score during 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: Baseline, Week 12
Cmax from Baseline through the End of Study (EoT) Visit of Part A
Cmax: Maximum observed serum concentration
Time frame: From Baseline through the End Of Study Visit (Week 12)
Tmax from Baseline through the End of Study (EoT) Visit of Part A
tmax: Time to maximum observed serum concentration
Time frame: From Baseline through the End of Study Visit (Week 12)
AUC(0-t) from Baseline through the End of Study (EoT) Visit of Part A
AUC(0-t): Area under the serum concentration-time curve from time zero to time t
Time frame: From Baseline through the End of Study Visit (Week 12)
AUC from Baseline through the End of Study (EoT) Visit of Part A
AUC: Area under the serum concentration-time curve from time 0 to last observed quantifiable concentration
Time frame: From Baseline through the End of Study Visit (Week 12)
F% from Baseline through the End of Study (EoT) Visit of Part A
F%= Bioavailability of subcutaneous route
Time frame: From Baseline through the End of Study Visit (Week 12)
Percent change from Baseline in the Eczema Area and Severity Index (EASI) score at Week 12 of 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: Baseline, Week 12
≥50% improvement vs Baseline in EASI score (EASI50) at Week 12 during 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: Baseline, Week 12
≥90% improvement vs Baseline in EASI score (EASI90) at Week 12 during 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: Baseline, Week 12
Cmax after the final dose of Part B
Cmax: Maximum observed serum concentration
Time frame: Week 12
Tmax after the final dose of Part B
tmax: Time to maximum observed serum concentration
Time frame: Week 12
AUCtau at Week 12 of Part B
AUCtau: Area under the curve for the dosing interval after the final dose
Time frame: Week 12