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Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis

Primary Purpose

Chronic Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-06700841
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring plaque psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug)
  • Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug)
  • Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug)
  • Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment)

Exclusion Criteria:

  • Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed
  • Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis
  • Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA)
  • Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).
  • Have taken Apremilast (Otezla) within 3 months of first dose of study drug.
  • Have undergone treatment with tofacitinib within 3 months of first dose.

Sites / Locations

  • Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA
  • Anaheim Clinical Trials, LLC
  • California Dermatology & Clinical Research Institute
  • Emil A. Tanghetti, MD dba Center for Dermatology and Laser Surgery
  • Southern California Dermatology
  • Tower Saint John's Imaging
  • Clinical Science Institute
  • Park Avenue Dermatology Administrative Annex
  • Park Avenue Dermatology
  • Olympian Clinical Research
  • Rose Radiology
  • Forward Clinical Trials, Inc
  • Dundee Dermatology
  • Dawes Fretzin Clinical Research Group, LLC
  • Dawes Fretzin Dermatology Group, LLC
  • Psoriasis Treatment Center of Central New Jersey
  • The Rockefeller University
  • Skin Search of Rochester, Inc.
  • Investigational Drug Services, UNC Hospitals
  • UNC Dermatology and Skin Cancer Center
  • UNC Clinical and Translation Research Center
  • Lynn Health Science Institute
  • Vital Prospects Clinical Research Institute, P.C
  • Health Concepts
  • Center for Clinical Studies
  • Lee Medical Associates, PA
  • Progressive Clinical Research, PA
  • Texas Dermatology and Laser Specialists
  • Virginia Clinical Research, Inc.
  • Premier Clinical Research
  • Wiseman Dermatology Research Inc.
  • Lynderm Research Inc
  • Research by ICLS
  • Skin Centre for Dermatology
  • The Centre for Dermatology
  • K.Papp Clinical Research Inc.
  • Diex Research Sherbrooke Inc.
  • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
  • Centrum Medyczne Enel-Med Przychodnia Grunwaldzka
  • Centrum Badan Klinicznych PI-House Sp. z o.o.
  • Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
  • NZOZ "Nasz Lekarz" - Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
  • MTZ Clinical Research Sp. z o.o.
  • WroMedica s.c.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

PF-06700841 60 mg followed by 30 mg once daily

PF-06700841 60 mg followed by 10 mg once daily

PF-06700841 60mg once daily followed by 100mg once weekly

PF-06700841 60mg once daily followed by placebo once daily

PF-06700841 30mg once daily

PF-06700841 30mg once daily followed by 10mg once daily

PF-06700841 30mg once daily followed by 100mg once weekly

Placebo

Arm Description

4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily

4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily

4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly

4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily

4 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily

4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily

4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly

12 weeks once daily placebo

Outcomes

Primary Outcome Measures

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. In each area, the sum of the severity rating scores for erythema, induration and scaling is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the four body areas is the PASI. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Secondary Outcome Measures

Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Change From Baseline in PASI Scores at Week 4 by Induction Dose
Change from baseline in PASI scores at Week 4 was presented by induction dose (ie, PF-06700841 60 mg QD, 30 mg QD, and placebo). The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16
A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
A PASI50 response is a 50% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
A PASI90 response is a 90% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16
The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or an important medical event. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs
The number of participants who discontinued from the study due to treatment-emergent AEs is presented. Note for data reported under this Outcome Measure: Per sponsor reporting standard, pregnancy was counted as AE for AE data tables while it was counted separately in the disposition data table (Participant Flow Module).
Change From Baseline in Blood Lipid Level at Weeks 4 and 12
Lipid panel included low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.
Number of Participants With Any Post-Baseline Laboratory Test Abnormalities
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio; chemistry (total bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, total cholesterol, LDL and HDL cholesterol, triglycerides, calcium, sodium, potassium, chloride, bicarbonate, glucose, creatine kinase, Cystatin C, glomerular filtration rate; urinalysis (pH, urine glucose, ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria, choriogonadotropin beta).
Number of Participants With Post-Baseline Vital Sign Abnormalities
Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) <50 mmHg; 3) sitting pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP >=30 mmHg.
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; a change from baseline of 30 to <60 msec or >=60 msec.

Full Information

First Posted
November 17, 2016
Last Updated
March 28, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02969018
Brief Title
Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
Official Title
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
plaque psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-06700841 60 mg followed by 30 mg once daily
Arm Type
Experimental
Arm Description
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily
Arm Title
PF-06700841 60 mg followed by 10 mg once daily
Arm Type
Experimental
Arm Description
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily
Arm Title
PF-06700841 60mg once daily followed by 100mg once weekly
Arm Type
Experimental
Arm Description
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
Arm Title
PF-06700841 60mg once daily followed by placebo once daily
Arm Type
Experimental
Arm Description
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily
Arm Title
PF-06700841 30mg once daily
Arm Type
Experimental
Arm Description
4 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily
Arm Title
PF-06700841 30mg once daily followed by 10mg once daily
Arm Type
Experimental
Arm Description
4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily
Arm Title
PF-06700841 30mg once daily followed by 100mg once weekly
Arm Type
Experimental
Arm Description
4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
12 weeks once daily placebo
Intervention Type
Drug
Intervention Name(s)
PF-06700841
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Description
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. In each area, the sum of the severity rating scores for erythema, induration and scaling is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the four body areas is the PASI. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame
Baseline (Day 1 pre-dose), Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
Description
A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame
Week 12
Title
Change From Baseline in PASI Scores at Week 4 by Induction Dose
Description
Change from baseline in PASI scores at Week 4 was presented by induction dose (ie, PF-06700841 60 mg QD, 30 mg QD, and placebo). The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame
Baseline (Day 1 pre-dose), Week 4
Title
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16
Description
A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame
Weeks 1, 2, 4, 6, 8, 10, 14, 16
Title
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Description
A PASI50 response is a 50% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame
Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Title
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Description
A PASI90 response is a 90% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame
Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Title
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16
Description
The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame
Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16
Title
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Description
The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Time Frame
Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or an important medical event. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Time Frame
From first dose of study treatment (Day 1) up to Week 20
Title
Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs
Description
The number of participants who discontinued from the study due to treatment-emergent AEs is presented. Note for data reported under this Outcome Measure: Per sponsor reporting standard, pregnancy was counted as AE for AE data tables while it was counted separately in the disposition data table (Participant Flow Module).
Time Frame
From first dose of study treatment (Day 1) up to Week 20
Title
Change From Baseline in Blood Lipid Level at Weeks 4 and 12
Description
Lipid panel included low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.
Time Frame
Baseline (Day 1 pre-dose), Weeks 4 and 12
Title
Number of Participants With Any Post-Baseline Laboratory Test Abnormalities
Description
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio; chemistry (total bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, total cholesterol, LDL and HDL cholesterol, triglycerides, calcium, sodium, potassium, chloride, bicarbonate, glucose, creatine kinase, Cystatin C, glomerular filtration rate; urinalysis (pH, urine glucose, ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria, choriogonadotropin beta).
Time Frame
From first dose of study treatment (Day 1) up to Week 16
Title
Number of Participants With Post-Baseline Vital Sign Abnormalities
Description
Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) <50 mmHg; 3) sitting pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP >=30 mmHg.
Time Frame
From first dose of study treatment (Day 1) up to Week 16
Title
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Description
ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; a change from baseline of 30 to <60 msec or >=60 msec.
Time Frame
From first dose of study treatment (Day 1) up to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug) Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug) Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug) Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment) Exclusion Criteria: Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz). Have taken Apremilast (Otezla) within 3 months of first dose of study drug. Have undergone treatment with tofacitinib within 3 months of first dose.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Emil A. Tanghetti, MD dba Center for Dermatology and Laser Surgery
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Southern California Dermatology
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Tower Saint John's Imaging
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Park Avenue Dermatology Administrative Annex
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Olympian Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Rose Radiology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Forward Clinical Trials, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Dundee Dermatology
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Dawes Fretzin Dermatology Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
The Rockefeller University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Skin Search of Rochester, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Investigational Drug Services, UNC Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
UNC Dermatology and Skin Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
UNC Clinical and Translation Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, P.C
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Lee Medical Associates, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Progressive Clinical Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Research by ICLS
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
Skin Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
K.Papp Clinical Research Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
City
Quebec
ZIP/Postal Code
G1V4X7
Country
Canada
Facility Name
Centrum Medyczne Enel-Med Przychodnia Grunwaldzka
City
Gdansk
ZIP/Postal Code
80-266
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House Sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
NZOZ "Nasz Lekarz" - Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
MTZ Clinical Research Sp. z o.o.
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
WroMedica s.c.
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
36045513
Citation
Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.
Results Reference
derived
PubMed Identifier
32311398
Citation
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.
Results Reference
derived
PubMed Identifier
30113844
Citation
Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7931004&StudyName=A+Phase+2a%2C+Randomized%2C+Double-blind%2C+Placebo-controlled+Study+To+Evaluate+Safety+And+Efficacy+Of+Pf-06700841+In+Subjects+With+Moderate+To+Severe+Plaque+Psoriasis
Description
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Learn more about this trial

Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis

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