Trial · NCT05732454
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16 | DB Period: Week 16 | IGA measured AD severity, based on a 5-point scale (0-4); 0= AD is clear, 1= AD is almost clear, 2= mild AD, 3= moderate AD and 4= severe AD. IGA response was defined as participants achieving IGA 0 (clear) or 1 (almost clear) and a reduction of \>=2 points from baseline. |
| Primary | Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality) | DB Period: From first dose of study drug up to 16 Weeks of treatment | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Primary | Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation | DB Period: From first dose of study drug up to 16 Weeks of treatment | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Primary | Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality) | DB Period: From first dose of study drug up to 16 Weeks of treatment | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of death); new or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medical events judged by investigator. |
| Primary | Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality) | DB Period: From first dose of study drug up to 16 Weeks of treatment | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. AESIs included here were cardiovascular events (i.e., bradycardia, Atrioventricular (AV) conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic infections \[including progressive multifocal leukoencephalopathy (PML)\], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and bilirubin elevation); posterior reversible encephalopathy syndrome (PRES) and malignancies. |
| Primary | Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities | DB Period: From first dose of study drug up to 16 Weeks of treatment | Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported. |
| Primary | Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks | DB Period: Pre-dose and 4 hours (hrs) post-dose on Day 1/Week 0; Pre-dose and 4 hrs post-dose on Day 113/Week 16 | Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. Number of participants with non-zero ECG abnormalities and AV blocks are reported in this outcome measure. |
| Primary | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | DB Period: Pre-dose and 1, 2, 3, 4 hours (hrs) post-dose on Day 1/Week 0; Day 29/Week 4; Day 57/Week 8; Day 85/Week 12; Pre-dose and 1, 2, 3, 4, 5 and 6 hrs post-dose on Day 113/Week 16 | Vital signs evaluation included systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure. |
| Primary | Part 1, OLE Period: Number of Participants With TEAEs (All Causality) | OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Primary | Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation | OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Primary | Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality) | OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of death); new or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medical events judged by investigator. |
| Primary | Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality) | OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. AESIs included here were cardiovascular events (i.e., bradycardia, AV conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic infections \[including PML\], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and/or bilirubin elevation); PRES and malignancies. |
| Primary | Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities | OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks) | Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported. |
| Primary | Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks | OLE Period: Day 169/Week 24 | Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTcF, and QRS complex. Number of participants with non-zero ECG abnormalities and AV blocks are reported in this outcome measure. |
| Primary | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | OLE Period: Day 141/Week 20; Day 169/Week 24; Day 281/Week 40; Follow Up 1; Follow Up 2 | Vital signs evaluation included SBP, DBP, pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure. |
| Secondary | Part 1, DB Period: Percentage of Participants Who Achieved >=75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75) at Week 16 | DB Period: Week 16 | EASI-75 response was defined as a 75% reduction or greater in EASI score from Baseline to Week 16. EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. |
| Secondary | Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16 | DB Period: Baseline, Week 16 | EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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