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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03850483
Registration number
NCT03850483
Ethics application status
Date submitted
20/02/2019
Date registered
21/02/2019
Date last updated
29/06/2022
Titles & IDs
Public title
Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
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Scientific title
A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL-GROUP, DOSE RANGING STUDY TO ASSESS EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 TOPICAL CREAM APPLIED ONCE OR TWICE DAILY FOR 12 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
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Secondary ID [1]
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0
2018-003051-38
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Secondary ID [2]
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B7931023
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriasis
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Condition category
Condition code
Skin
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0
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PF-06700841
Treatment: Drugs - Vehicle (Placebo)
Placebo Comparator: Vehicle cream QD - Vehicle cream applied once daily (QD)
Experimental: PF-06700841 0.1% cream QD - PF-06700841 0.1% cream applied once daily (QD)
Experimental: PF-06700841 0.3% cream QD - PF-06700841 0.3% cream applied once daily (QD)
Experimental: PF-06700841 1% cream QD - PF-06700841 1% cream applied once daily (QD)
Experimental: PF-06700841 3% cream QD - PF-06700841 3% cream applied once daily (QD)
Experimental: PF-06700841 0.3% cream BID - PF-06700841 0.3% cream applied twice daily (BID)
Experimental: PF-06700841 1% cream BID - PF-06700841 1% cream applied twice daily (BID)
Placebo Comparator: Vehicle cream BID - Vehicle cream applied twice daily (BID)
Experimental: PF-06700841 3% cream BID - PF-06700841 3% cream applied twice daily (BID)
Treatment: Drugs: PF-06700841
PF-06700841 topical cream
Treatment: Drugs: Vehicle (Placebo)
Vehicle topical cream
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
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Assessment method [1]
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The Psoriasis Area and Severity Index (PASI) score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected body surface area (BSA) from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
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Timepoint [1]
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Baseline, Week 12
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Secondary outcome [1]
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Percentage of Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12
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Assessment method [1]
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PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category. Scale for PGA: 0= clear, 1= almost clear, 2= mild, 3= moderate and 4= severe. Higher scores indicate more severity.
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Timepoint [1]
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Baseline, Week 12
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Secondary outcome [2]
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Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
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Assessment method [2]
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The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
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Timepoint [2]
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Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
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Secondary outcome [3]
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Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
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Assessment method [3]
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The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
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Timepoint [3]
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Baseline, Week 1, 2, 4, 6, 8, 10 and 12
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Secondary outcome [4]
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Change From Baseline in PASI Scores at Week 14 and 16
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Assessment method [4]
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The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
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Timepoint [4]
0
0
Baseline, Week 14 and 16
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Secondary outcome [5]
0
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Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
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Assessment method [5]
0
0
The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
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Timepoint [5]
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0
Baseline, Week 1, 2, 4, 6, 8, 10 and 12
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Secondary outcome [6]
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Percent Change From Baseline in PASI Scores at Week 14 and 16
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Assessment method [6]
0
0
The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs.
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Timepoint [6]
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Baseline, Week 14 and 16
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Secondary outcome [7]
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Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12
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Assessment method [7]
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Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch.
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Timepoint [7]
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Baseline, Week 1, 2, 4, 6, 8, 10 and 12
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Secondary outcome [8]
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Absolute PP-NRS Score at Week 14 and 16
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Assessment method [8]
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Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch.
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Timepoint [8]
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0
Week 14 and 16
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Secondary outcome [9]
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Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12
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Assessment method [9]
0
0
Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch.
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Timepoint [9]
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Baseline, Week 1, 2, 4, 6, 8, 10 and 12
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Secondary outcome [10]
0
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Change From Baseline in PP-NRS Score at Week 14 and 16
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Assessment method [10]
0
0
Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch.
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Timepoint [10]
0
0
Baseline, Week 14 and 16
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Secondary outcome [11]
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Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
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Assessment method [11]
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PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity.
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Timepoint [11]
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Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET)
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Secondary outcome [12]
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Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
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Assessment method [12]
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PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity.
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Timepoint [12]
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Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET)
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Secondary outcome [13]
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Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16
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Assessment method [13]
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PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category. Scale for PGA: 0= clear, 1= almost clear, 2= mild, 3= moderate and 4= severe. Higher scores indicate more severity.
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Timepoint [13]
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Baseline, Week 1, 2, 4, 6, 8, 10, 14, and 16
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Secondary outcome [14]
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Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
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Assessment method [14]
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PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity.
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Timepoint [14]
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Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
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Secondary outcome [15]
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Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs
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Assessment method [15]
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs. Treatment emergent AEs (TEAEs) were events that occurred between first dose of study drug and up to 4 weeks after last dose that were absent before treatment or that worsened relative to pretreatment state. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.
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Timepoint [15]
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Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
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Secondary outcome [16]
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Number of Participants With TEAEs by Severity
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Assessment method [16]
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An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event).
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Timepoint [16]
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Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
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Secondary outcome [17]
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Number of Participants Who Discontinued From Study Due to Adverse Events
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Assessment method [17]
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An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
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Timepoint [17]
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Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
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Secondary outcome [18]
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Number of Participants With Laboratory Abnormalities Meeting Specified Criteria
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Assessment method [18]
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Bilirubin: greater than (>) 1.5* upper limit normal (ULN); aspartate aminotransferase, alanine aminotransferase: >2.5*ULN; creatinine, cystatin C: >1.3*ULN; creatine kinase: >2.0*ULN; glomerular filtration rate (GFR) CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Equat: less than (<) 60 milliliter (mL)/minute (min)/1.73 meter(m)^2, greater than or equal to (>=) 30% decrease from baseline; GFR: <60 mL/min/1.73m^2.
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Timepoint [18]
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0
Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
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Secondary outcome [19]
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Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data
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Assessment method [19]
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Following were ECG criteria used for categorical summary:1) PR interval: percentage change >=25/50%, QRS interval: value >140 msec, and QT interval corrected using the Fridericia's formula (QTcF): 450 msec < value less than equal to (<=) 480 and 30 < change <=60.
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Timepoint [19]
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Post-baseline to Week 6, Post-baseline to Week 12
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Secondary outcome [20]
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Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
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Assessment method [20]
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Following were the vital signs criteria: 1) Pulse rate: value <40 beats per min (bpm), value >120 bpm; 2) Sitting diastolic blood pressure (DBP): value <50 mmHg; change >=20 mmHg increase; change >=20 mmHg decrease; 3) Sitting systolic blood pressure (SBP): value <90 mmHg, change >=30 mmHg increase, change >=30 mmHg decrease; 4) Supine DBP: value <50 mmHg, change >=20 mmHg increase, change >=20 mmHg decrease; 5) Supine SBP: value <90 mmHg, change >=30 mmHg increase, change >=30 mmHg decrease.
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Timepoint [20]
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Post-baseline to Week 12
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Secondary outcome [21]
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Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
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Assessment method [21]
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At the site of study drug application, skin tolerability was assessed for non-lesional skin surrounding the plaques on a scale from 0 to 4. Grade 0= none (no evidence of local intolerance), Grade 1= mild (minimal erythema and/or edema, slight glazed appearance), Grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology), Grade 3= severe, reported as AE (erythema, oedema glazing with fissures, few vesicles or papules: consider removing topical agent [if still in place]), Grade 4= very severe, reported as AE (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]).
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Timepoint [21]
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Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
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Eligibility
Key inclusion criteria
- plaque psoriasis for 6 months
- PGA score mild or moderate
- body surface area (BSA) 2-15%
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- other skin conditions that would interfere with the evaluation of psoriasis
- history of herpes zoster or simplex
- Infected with Mycobacterium tuberculosis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/04/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/04/2021
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Sample size
Target
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Accrual to date
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Final
344
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Veracity Clinical Research Pty Ltd - Woolloongabba
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Recruitment hospital [2]
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0
Emeritus Research - Camberwell
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Recruitment hospital [3]
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0
Sinclair Dermatology - East Melbourne
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Recruitment hospital [4]
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0
Cabrini Hospital - Malvern
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Recruitment postcode(s) [1]
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0
4102 - Woolloongabba
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Recruitment postcode(s) [2]
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0
3124 - Camberwell
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Recruitment postcode(s) [3]
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0
3002 - East Melbourne
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Recruitment postcode(s) [4]
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0
3144 - Malvern
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arkansas
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Connecticut
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Illinois
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Indiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Kentucky
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Louisiana
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Missouri
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Country [11]
0
0
United States of America
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State/province [11]
0
0
New Jersey
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Country [12]
0
0
United States of America
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State/province [12]
0
0
New York
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Country [13]
0
0
United States of America
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State/province [13]
0
0
North Carolina
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Oklahoma
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Country [15]
0
0
United States of America
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State/province [15]
0
0
South Dakota
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Tennessee
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Texas
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Virginia
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Country [19]
0
0
Bulgaria
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State/province [19]
0
0
Sofia
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Country [20]
0
0
Canada
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State/province [20]
0
0
Manitoba
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Country [21]
0
0
Canada
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State/province [21]
0
0
Ontario
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Country [22]
0
0
Canada
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State/province [22]
0
0
Quebec
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Country [23]
0
0
Denmark
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State/province [23]
0
0
Hellerup
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Country [24]
0
0
Germany
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State/province [24]
0
0
Bad Bentheim
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Country [25]
0
0
Germany
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State/province [25]
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Berlin
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Germany
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Bielefeld
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Germany
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Dresden
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Germany
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Hamburg
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Germany
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Mahlow
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Germany
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Schwerin
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Kecskemet
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Hungary
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Szeged
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Japan
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Hokkaido
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Japan
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Osaka
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Japan
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Tokyo
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Latvia
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Riga
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Latvia
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Ventspils
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Poland
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Bialystok
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Poland
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Torun
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Poland
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Warszawa
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Poland
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Wroclaw
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Ethics approval
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Summary
Brief summary
This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter
study in participants with mild to moderate plaque psoriasis. The duration of study
participation will be approximately 22 weeks, including up to a 6 week screening period, 12
week treatment period, and approximately 4 week follow up period. Approximately 280
participants are planned to be randomized into the study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03850483
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Trial related presentations / publications
Forman SB, Pariser DM, Poulin Y, Vincent MS, Gilbert SA, Kieras EM, Qiu R, Yu D, Papacharalambous J, Tehlirian C, Peeva E. TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial. J Invest Dermatol. 2020 Dec;140(12):2359-2370.e5. doi: 10.1016/j.jid.2020.03.962. Epub 2020 Apr 18.
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03850483
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