Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug2201 | Intravenous Placebo Wiki | 1.00 |
drug5219 | severity of lung involvement with COVID-19. Wiki | 1.00 |
drug4175 | Subcutaneous Placebo Wiki | 1.00 |
Name (Synonyms) | Correlation | |
---|---|---|
D004485 | Eczema NIH | 0.50 |
D003876 | Dermatitis, Atopic NIH | 0.50 |
D003872 | Dermatitis NIH | 0.45 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0000964 | Eczema HPO | 0.50 |
HP:0001047 | Atopic dermatitis HPO | 0.50 |
HP:0011123 | Inflammatory abnormality of the skin HPO | 0.45 |
Navigate: Correlations HPO
There is one clinical trial.
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 outcome in study participants with atopic dermatitis after administration of UCB9741 by intravenous infusion will be investigated.
Description: 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.
Measure: Incidence of treatment-emergent adverse events (TEAEs) during Part A Time: From Baseline up to the End of Study Visit (Week 12)Description: 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
Measure: Incidence of treatment-emergent serious adverse events (TESAEs) during Part A Time: From Baseline up to the End of Study Visit (Week 12)Description: Administration-site reactions include: Erythema, itching, haematoma, pain, swelling or bruising.
Measure: Incidence of administration-site reactions during Part A Time: From Baseline up to the End of Study Visit (Week 12)Description: Signs or symptoms experienced by study participants during the infusion of the IMP, typically on the first day of drug administration. Detailed history will be obtained of the suspected infusion/injection reaction (eg, rash and associated symptoms and signs) with onset time of symptoms and signs, location of symptoms and signs, first appearance, and its evolution (eg, where the rash appeared and its overall spread), any other symptoms (eg, pruritus, swelling, breathlessness)
Measure: Incidence of infusion/injection reactions during Part A Time: From Baseline up to the End of Study Visit (Week 12)Description: Acute onset of an illness with involvement of the skin, mucosal tissue, or both and at least 1 of the following: Respiratory compromise Reduced blood pressure or associated symptoms of end-organ dysfunction Involvement of the skin-mucosal tissue Respiratory compromise Reduced blood pressure or associated symptoms Persistent gastrointestinal symptoms Reduced blood pressure after exposure to known allergen for that participant
Measure: Incidence of anaphylaxis during Part A Time: From Baseline up to the End of Study Visit (Week 12)Description: Detailed history will be obtained of the suspected hypersensitivity event (eg, rash and associated symptoms and signs) with onset time of symptoms and signs, location of symptoms and signs, first appearance, and its evolution (eg, where the rash appeared and its overall spread), any other symptoms (eg, pruritus, swelling, breathlessness)
Measure: Incidence of hypersensitivity during Part A Time: From Baseline up to the End of Study Visit (Week 12)Description: 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.
Measure: Incidence of TEAEs during Part B Time: From Baseline up to the End of Study Visit (Week 22)Description: 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
Measure: Incidence of TESAEs during Part B Time: From Baseline up to the End of Study Visit (Week 22)Description: Administration-site reactions include: Erythema, itching, haematoma, pain, swelling or bruising.
Measure: Incidence of administration-site reactions during Part B Time: From Baseline up to the End of Study Visit (Week 22)Description: Signs or symptoms experienced by study participants during the infusion of the Investigational medicinal product (IMP), typically on the first day of drug administration. Detailed history will be obtained of the suspected infusion reaction (eg, rash and associated symptoms and signs) with onset time of symptoms and signs, location of symptoms and signs, first appearance, and its evolution (eg, where the rash appeared and its overall spread), any other symptoms (eg, pruritus, swelling, breathlessness)
Measure: Incidence of infusion reactions during Part B Time: From Baseline up to the End of Study Visit (Week 22)Description: Detailed history will be obtained of the suspected hypersensitivity event (eg, rash and associated symptoms and signs) with onset time of symptoms and signs, location of symptoms and signs, first appearance, and its evolution (eg, where the rash appeared and its overall spread), any other symptoms (eg, pruritus, swelling, breathlessness)
Measure: Incidence of hypersensitivity during Part B Time: From Baseline up to the End of Study Visit (Week 22)Description: Acute onset of an illness with involvement of the skin, mucosal tissue, or both and at least 1 of the following: Respiratory compromise Reduced blood pressure or associated symptoms of end-organ dysfunction Involvement of the skin-mucosal tissue Respiratory compromise Reduced blood pressure or associated symptoms Persistent gastrointestinal symptoms Reduced blood pressure after exposure to known allergen for that participant
Measure: Incidence of anaphylaxis during Part B Time: From Baseline up to the End of Study Visit (Week 22)Description: 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.
Measure: ≥75% improvement vs Baseline in Eczema Area and Severity Index (EASI75) score during Part B Time: Baseline, Week 12Description: Cmax: Maximum observed serum concentration
Measure: Cmax from Baseline through the End of Study (EoT) Visit of Part A Time: From Baseline through the End Of Study Visit (Week 12)Description: tmax: Time to maximum observed serum concentration
Measure: Tmax from Baseline through the End of Study (EoT) Visit of Part A Time: From Baseline through the End of Study Visit (Week 12)Description: AUC(0-t): Area under the plasma concentration-time curve from time zero to time t
Measure: AUC(0-t) from Baseline through the End of Study (EoT) Visit of Part A Time: From Baseline through the End of Study Visit (Week 12)Description: AUC: Area under the plasma concentration-time curve from time 0 to last observed quantifiable concentration
Measure: AUC from Baseline through the End of Study (EoT) Visit of Part A Time: From Baseline through the End of Study Visit (Week 12)Description: F%= Bioavailability of administration
Measure: F% from Baseline through the End of Study (EoT) Visit of Part A Time: From Baseline through the End of Study Visit (Week 12)Description: 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.
Measure: Percent change from Baseline in the Eczema Area and Severity Index (EASI) score at Week 12 of Part B Time: Baseline, Week 12Description: 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.
Measure: ≥50% improvement vs Baseline in EASI score (EASI50) at Week 12 during Part B Time: Baseline, Week 12Description: 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.
Measure: ≥90% improvement vs Baseline in EASI score (EASI90) at Week 12 during Part B Time: Baseline, Week 12Description: Cmax: Maximum observed serum concentration
Measure: Cmax after the first and final dose of Part B Time: Day 1, Week 12Description: tmax: Time to maximum observed serum concentration
Measure: Tmax after the first and final dose of Part B Time: Day 1, Week 12Description: AUCtau: Area under the curve for the dosing interval after the final dose
Measure: AUCtau at Week 12 of Part B Time: Week 12Description: Ctrough: Measured predose concentration at the end of the dosing interval
Measure: Ctrough during Week 12 of Part B Time: Week 12Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports