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D004485: Eczema

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (12)


Name (Synonyms) Correlation
drug5209 semen analysis Wiki 0.50
drug2776 Nemolizumab Wiki 0.50
drug153 ATI-1777 Wiki 0.50
Name (Synonyms) Correlation
drug4545 UCB9741 Wiki 0.50
drug2201 Intravenous Placebo Wiki 0.50
drug1850 Hand sanitizer and hand washing Wiki 0.50
drug4635 Vehicle Wiki 0.50
drug5219 severity of lung involvement with COVID-19. Wiki 0.50
drug881 CYP 450 Substrates Wiki 0.50
drug5216 serum inflammatory biomarkers Wiki 0.50
drug4175 Subcutaneous Placebo Wiki 0.50
drug5211 serology Wiki 0.35

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D003876 Dermatitis, Atopic NIH 1.00
D003872 Dermatitis NIH 0.89
D012868 Skin Abnormalities NIH 0.50

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0000964 Eczema HPO 1.00
HP:0001047 Atopic dermatitis HPO 1.00
HP:0011123 Inflammatory abnormality of the skin HPO 0.89
Name (Synonyms) Correlation
HP:0000951 Abnormality of the skin HPO 0.35

Clinical Trials

Navigate: Correlations   HPO

There are 4 clinical trials


1 Hand Sanitizer Effects on the Skin Barrier

Hand washing and the use of hand sanitizers are important interventions in disease prevention. Engaging in frequent hand washing is especially effective in preventing the spread of viruses, as this removes microbes and prevents the spread to others. Hand dermatitis, however, is a common occurrence in certain occupations, such as healthcare workers. With the onset of the SARS-CoV2 (COVID-19) pandemic, hand hygiene measures are further enforced as there is no cure or vaccine for this virus. In the study, the effects of hand washing and the use of hand sanitizer on skin proteins and lipids will be assessed.

NCT04525521
Conditions
  1. Dermatitis Hand
  2. Skin Abnormalities
  3. Atopic Dermatitis
  4. Atopic Dermatitis Eczema
Interventions
  1. Other: Hand sanitizer and hand washing
MeSH:Dermatitis, Atopic Skin Abnormalities Dermatitis Eczema
HPO:Abnormality of the skin Atopic dermatitis Eczema Eczematoid dermatitis Inflammatory abnormality of the skin

Primary Outcomes

Description: Skin barrier assessments at baseline, then after hand sanitizer use will be performed. Analysis of skin filaggrin breakdown products, lipid profiles, and transepidermal water loss will be compared.

Measure: Measure the change in transepidermal water loss and skin components after using hand sanitizer.

Time: Through study completion, up to 1 year

Description: Skin barrier assessments after hand washing with soap and water will be performed. Analysis of skin filaggrin breakdown products, lipid profiles, and transepidermal water loss will be compared.

Measure: Measure the change in transepidermal water loss and skin components after hand washing with soap and water.

Time: Through study completion, up to 1 year

Secondary Outcomes

Description: Questionnaires will capture symptoms of hand dryness, frequency of hand washing, and other environmental exposures. This data will be compared to the degree of transepidermal water loss and skin barrier findings.

Measure: Individual reporting of hand dryness and environmental exposures

Time: Through study completion, up to 1 year
2 An Open-label Drug-Drug Interaction Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Subjects With Moderate-to-Severe Atopic Dermatitis

The purpose of this study is to evaluate the effect of nemolizumab (CD14152) on the pharmacokinetics (PK) of a drug "cocktail" representative of CYP450 (CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4/5 sensitive index substrates) in adult participants with moderateto- severe atopic dermatitis (AD).

NCT04562116
Conditions
  1. Atopic Dermatitis
Interventions
  1. Drug: Nemolizumab
  2. Drug: CYP 450 Substrates
MeSH:Dermatitis, Atopic Dermatitis Eczema
HPO:Atopic dermatitis Eczema Eczematoid dermatitis Inflammatory abnormality of the skin

Primary Outcomes

Description: Change of AUC (0-infinity) of each of the 5 probe drugs before and after 9-week nemolizumab treatment will be assessed. AUC (0-infinity) is defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-BQL) concentration; and lambda(z) is apparent terminal elimination rate constant.

Measure: Change of Area Under the Concentration-time Curve from Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment

Time: Baseline (Week 0) and Week 10: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose'

Description: Change of AUC (0-last) of each of the 5 probe drugs before and after 9-week nemolizumab treatment will be assessed. AUC (0-last) is defined as AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.

Measure: Change of Area Under the Concentration-time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment

Time: Baseline (Week 0) and Week 10: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose'

Description: Change of Cmax of each of the 5 probe drugs before and after 9-week nemolizumab treatment will be assessed. Cmax is defined as the maximum observed plasma concentration.

Measure: Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment

Time: Baseline (Week 0) and Week 10: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose'

Secondary Outcomes

Description: Incidence of AEs including treatment emergent AEs (TEAEs), AEs of special interest (AESIs), and serious AEs (SAEs) will be reported. An AE is defined as any untoward medical occurrence in a study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. A TEAE is defined as an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. An AESI is a noteworthy treatment-emergent event for the study drug that should be monitored closely and reported promptly.

Measure: Incidence of Adverse Events (AEs)

Time: Up to 24 weeks

Description: The severity of AEs including TEAEs, AESIs, and SAEs will be assessed as mild, moderate or severe.

Measure: Severity of Adverse Events (AEs)

Time: Up to 24 weeks
3 A Phase 2a, Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis

This is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following twice-daily applications to target areas of patients with moderate or severe atopic dermatitis.

NCT04598269
Conditions
  1. Atopic Dermatitis
Interventions
  1. Drug: ATI-1777
  2. Drug: Vehicle
MeSH:Dermatitis, Atopic Dermatitis Eczema
HPO:Atopic dermatitis Eczema Eczematoid dermatitis Inflammatory abnormality of the skin

Primary Outcomes

Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.

Measure: Percent change from baseline in EASI score at Day 28

Time: Baseline to Day 28

Secondary Outcomes

Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.

Measure: Percent change from baseline in EASI score at Day 8

Time: Baseline to Day 8

Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.

Measure: Percent change from baseline in EASI score at Day 15

Time: Baseline to Day 15

Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.

Measure: Proportion of patients who achieve 50% improvement in EASI score (EASI 50) within 28 days of the start of treatment

Time: Day 28

Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.

Measure: Proportion of patients who achieve 75% improvement in EASI score (EASI-75) within 4 weeks of the start of treatment

Time: Baseline to Day 28

Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.

Measure: Proportions of patients who achieve 90% improvement in EASI score (EASI-90) within 4 weeks of the start of treatment

Time: Baseline to Day 28

Description: IGA = Validated Investigator Global Assessment scale for Atopic Dermatitis. The IGA is the investigator's assessment of the average overall severity of patient's AD at a particular point in time. Scores range from 0-4, with higher scores indicative of more severe disease.

Measure: Change from baseline in IGA score at Day 8

Time: Baseline to Day 8

Description: IGA = Validated Investigator Global Assessment scale for Atopic Dermatitis. The IGA is the investigator's assessment of the average overall severity of patient's AD at a particular point in time. Scores range from 0-4, with higher scores indicative of more severe disease.

Measure: Change from baseline in IGA score at Day 15

Time: Baseline to Day 15

Description: IGA = Validated Investigator Global Assessment scale for Atopic Dermatitis. The IGA is the investigator's assessment of the average overall severity of patient's AD at a particular point in time. Scores range from 0-4, with higher score indicative of more severe disease. 0-100%, with higher score indicative of increased percentage of atopic dermatitis on the skin.

Measure: Change from baseline in IGA score at Day 28

Time: Baseline to Day 28

Description: BSA = Percent of Body Surface Area of Atopic Dermatitis. The total percentage of the patient's BSA affected by AD will be estimated by the investigator or designee using the handprint method, which estimates that the area of a patient's full handprint (fingers and thumbs together) constitutes 1% of their total BSA. Scores range from 0-100%, with higher score indicative of increased percentage of atopic dermatitis on the skin.

Measure: Change from baseline in BSA at Day 8

Time: Baseline to Day 8

Description: BSA = Percent of Body Surface Area of Atopic Dermatitis. The total percentage of the patient's BSA affected by AD will be estimated by the investigator or designee using the handprint method, which estimates that the area of a patient's full handprint (fingers and thumbs together) constitutes 1% of their total BSA. Scores range from 0-100%, with higher score indicative of increased percentage of atopic dermatitis on the skin.

Measure: Change from baseline in BSA at Day 15

Time: Baseline to Day 15

Description: BSA = Percent of Body Surface Area of Atopic Dermatitis. The total percentage of the patient's BSA affected by AD will be estimated by the investigator or designee using the handprint method, which estimates that the area of a patient's full handprint (fingers and thumbs together) constitutes 1% of their total BSA. Scores range from 0-100%, with higher score indicative of increased percentage of atopic dermatitis on the skin.

Measure: Change from baseline in BSA at Day 28

Time: Baseline to Day 28

Description: PP-NRS = Peak Pruritus Numerical Rating Scale. The PP-NRS is a single patient-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours. Scores range from 0-10, with higher scores indicative of more severe itching.

Measure: Change from baseline in PP-NRS score at Day 8

Time: Baseline to Day 8

Description: PP-NRS = Peak Pruritus Numerical Rating Scale. The PP-NRS is a single patient-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours. Scores range from 0-10, with higher scores indicative of more severe itching.

Measure: Change from baseline in PP-NRS at Day 15

Time: Baseline to Day 15

Description: PP-NRS = Peak Pruritus Numerical Rating Scale. The PP-NRS is a single patient-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours. Scores range from 0-10, with higher scores indicative of more severe itching.

Measure: Change from baseline in PP-NRS score at Day 28

Time: Baseline to Day 28

Other Outcomes

Description: Laboratory measure will be categorized as normal, high, or low. Normal laboratory values represent better outcomes. Laboratory measures include White Blood Cell (WBC) Count, Absolute Neutrophil Count (ANC), Aspartate Aminotransferase, Lymphocyte count, Platelet count, Hemoglobin, and Serum creatinine. The status at the final value at the end of the treatment period will be compared with that at the study baseline and the "shifts" from study baseline will be summarized using the number and percentage of patients in each shift category by treatment group.

Measure: Proportion of Subjects Experiencing a Shift from Baseline Laboratory Values

Time: Baseline to Day 28

Description: Laboratory measure will be summarized using descriptive statistics for numeric variables and numbers and percentages for categorical variables at each scheduled assessment. Numeric hematology, chemistry, and urinalysis results will be summarized using change from baseline as well.

Measure: Summary of Hematology at Day 28

Time: Baseline to Day 28

Description: Laboratory measure will be summarized using descriptive statistics for numeric variables and numbers and percentages for categorical variables at each scheduled assessment. Numeric hematology, chemistry, and urinalysis results will be summarized using change from baseline as well.

Measure: Summary of Serum Chemistry at Day 28

Time: Baseline to Day 28

Description: Laboratory measure will be summarized using descriptive statistics for numeric variables and numbers and percentages for categorical variables at each scheduled assessment. Numeric hematology, chemistry, and urinalysis results will be summarized using change from baseline as well.

Measure: Summary of Urinalysis at Day 28

Time: Baseline to Day 28

Description: Vital signs will be presented descriptively. Vital signs will be measured in a semi-supine position after 5 minutes of rest and will include temperature, systolic and diastolic blood pressure, pulse, and respiratory rate.

Measure: Summary of Abnormal Vital Signs at Day 8

Time: Baseline to Day 8

Description: Vital signs will be presented descriptively. Vital signs will be measured in a semi-supine position after 5 minutes of rest and will include temperature, systolic and diastolic blood pressure, pulse, and respiratory rate.

Measure: Summary of Abnormal Vital Signs at Day 15

Time: Baseline to Day 15

Description: Vital signs will be presented descriptively. Vital signs will be measured in a semi-supine position after 5 minutes of rest and will include temperature, systolic and diastolic blood pressure, pulse, and respiratory rate.

Measure: Summary of Abnormal Vital Signs at Day 28

Time: Baseline to Day 28

Description: ECG = Electrocardiogram. Clinically significant ECG findings include, but not limited to, ectopic atrial rhythm, clinically significant conduction disturbance including PR >240 msec, pre-excitation (delta wave and PR < 120 msec), second degree or higher atrioventricular block, new finding of QRS > 120 ms, evidence of of QT-interval prolongation, and acute signs of ischemia or infarction.

Measure: Summary of Abnormal Physical 12-lead ECG reading at Day 28

Time: Baseline to Day 28
4 A Phase I/IIA, Randomized, Placebo-Controlled, Single-Ascending Dose (Part A, Participant- and Investigator-Blind) and Repeated-Dose (Part B, Participant-, Investigator-, and Sponsor-Blind) Study to Investigate the Safety, Pharmacokinetics and Efficacy of UCB9741 in Healthy Study Participants (Part A) and in Study Participants With Moderate-to-Severe Atopic Dermatitis (Part B)

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.

NCT04643457
Conditions
  1. Atopic Dermatitis
Interventions
  1. Drug: UCB9741
  2. Drug: Intravenous Placebo
  3. Drug: Subcutaneous Placebo
MeSH:Dermatitis, Atopic Dermatitis Eczema
HPO:Atopic dermatitis Eczema Eczematoid dermatitis Inflammatory abnormality of the skin

Primary Outcomes

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 12

Secondary Outcomes

Description: 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 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: ≥50% improvement vs Baseline in EASI score (EASI50) at Week 12 during Part B

Time: Baseline, 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: ≥90% improvement vs Baseline in EASI score (EASI90) at Week 12 during Part B

Time: Baseline, Week 12

Description: Cmax: Maximum observed serum concentration

Measure: Cmax after the first and final dose of Part B

Time: Day 1, Week 12

Description: tmax: Time to maximum observed serum concentration

Measure: Tmax after the first and final dose of Part B

Time: Day 1, Week 12

Description: AUCtau: Area under the curve for the dosing interval after the final dose

Measure: AUCtau at Week 12 of Part B

Time: Week 12

Description: Ctrough: Measured predose concentration at the end of the dosing interval

Measure: Ctrough during Week 12 of Part B

Time: Week 12

HPO Nodes


Reports

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.

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