Chronic Plaque PsoriasisPhase 2NCT02969018
Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
A Phase 2 study testing PF-06700841 in people with Chronic Plaque Psoriasis, run by Pfizer at 44 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- PF-06700841
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 44 sitesin 3 countries
- Study dates
- Dec 2016to Mar 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
44 sites in 3 countries.
44 sites in 3 countries
United States30 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Investigational Drug Services, UNC Hospitals
Chapel Hill, North Carolina, 27514
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516
UNC Clinical and Translation Research Center
Chapel Hill, North Carolina, 27599
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Center for Clinical Studies
Houston, Texas, 77004
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, 46256
The Rockefeller University
New York, New York, 10065
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Park Avenue Dermatology Administrative Annex
Orange Park, Florida, 32073
Park Avenue Dermatology
Orange Park, Florida, 32073
Health Concepts
Rapid City, South Dakota, 57702
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA
Rogers, Arkansas, 72758
Emil A. Tanghetti, MD dba Center for Dermatology and Laser Surgery
Sacramento, California, 95819
Lee Medical Associates, PA
San Antonio, Texas, 78213
Progressive Clinical Research, PA
San Antonio, Texas, 78213
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Southern California Dermatology
Santa Ana, California, 92701
Tower Saint John's Imaging
Santa Monica, California, 90403
Clinical Science Institute
Santa Monica, California, 90404
Premier Clinical Research
Spokane, Washington, 99202
Olympian Clinical Research
Tampa, Florida, 33609
Rose Radiology
Tampa, Florida, 33609
Forward Clinical Trials, Inc
Tampa, Florida, 33624
Vital Prospects Clinical Research Institute, P.C
Tulsa, Oklahoma, 74136
Dundee Dermatology
West Dundee, Illinois, 60118
Canada8 sites
Lynderm Research Inc
Markham, Ontario, L3P 1X2
Research by ICLS
Oakville, Ontario, L6J 7W5
Skin Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, Quebec, G1V4X7
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8
K.Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
Poland6 sites
Centrum Medyczne Enel-Med Przychodnia Grunwaldzka
Gdansk, 80-266
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, 80-546
Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
Lodz, 90-436
NZOZ "Nasz Lekarz" - Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
Torun, 87-100
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106
WroMedica s.c.
Wroclaw, 51-685
About this study
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
The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- PF-06700841, Placebo
- Keywords
- plaque psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06700841Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| PF-06700841 60 mg followed by 30 mg once daily | Experimental | 4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily Receives: Drug: PF-06700841 |
| PF-06700841 60 mg followed by 10 mg once daily | Experimental | 4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily Receives: Drug: PF-06700841 |
| PF-06700841 60mg once daily followed by 100mg once weekly | Experimental | 4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly Receives: Drug: PF-06700841 |
| PF-06700841 60mg once daily followed by placebo once daily | Experimental | 4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily Receives: Drug: PF-06700841 |
| PF-06700841 30mg once daily | Experimental | 4 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily Receives: Drug: PF-06700841 |
| PF-06700841 30mg once daily followed by 10mg once daily | Experimental | 4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily Receives: Drug: PF-06700841 |
| PF-06700841 30mg once daily followed by 100mg once weekly | Experimental | 4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly Receives: Drug: PF-06700841 |
| Placebo | Placebo comparator | 12 weeks once daily placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1 pre-dose), Week 12
Secondary outcomes (13)
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.
Measured: Week 12
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.
Measured: Baseline (Day 1 pre-dose), Week 4
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.
Measured: Weeks 1, 2, 4, 6, 8, 10, 14, 16
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.
Measured: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
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.
Measured: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
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.
Measured: Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16
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.
Measured: Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
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.
Measured: From first dose of study treatment (Day 1) up to Week 20
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).
Measured: From first dose of study treatment (Day 1) up to Week 20
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.
Measured: Baseline (Day 1 pre-dose), Weeks 4 and 12
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).
Measured: From first dose of study treatment (Day 1) up to Week 16
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.
Measured: From first dose of study treatment (Day 1) up to Week 16
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.
Measured: From first dose of study treatment (Day 1) up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969018
- Sponsor's protocol ID
- B7931004
- Other IDs
- 2016-004049-96, 2016
- Status last verified
- Mar 2019
- First submitted
- 17 Nov 2016
- Last updated
- 29 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36045513Forman 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.
PubMed 32311398Fensome 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.
PubMed 30113844
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02969018
- Acronym / sponsor ID
- B7931004
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- plaque psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Posted 29 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| PF-06700841 60 mg followed by 30 mg once daily | Experimental | Drug: PF-067008414 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily |
| PF-06700841 60 mg followed by 10 mg once daily | Experimental | Drug: PF-067008414 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily |
| PF-06700841 60mg once daily followed by 100mg once weekly | Experimental | Drug: PF-067008414 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly |
| PF-06700841 60mg once daily followed by placebo once daily | Experimental | Drug: PF-067008414 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily |
| PF-06700841 30mg once daily | Experimental | Drug: PF-067008414 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily |
| PF-06700841 30mg once daily followed by 10mg once daily | Experimental | Drug: PF-067008414 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily |
| PF-06700841 30mg once daily followed by 100mg once weekly | Experimental | Drug: PF-067008414 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly |
| Placebo | Placebo comparator | Other: Placebo12 weeks once daily placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-06700841 | Drug | PF-06700841 30mg once daily, PF-06700841 30mg once daily followed by 100mg once weekly, PF-06700841 30mg once daily followed by 10mg once daily, PF-06700841 60 mg followed by 10 mg once daily, PF-06700841 60 mg followed by 30 mg once daily, PF-06700841 60mg once daily followed by 100mg once weekly, PF-06700841 60mg once daily followed by placebo once daily |
| Placebo | Other | Placebo |
Primary outcome
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Time frame: Baseline (Day 1 pre-dose), 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.
13 secondary outcomes
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
Time frame: Week 12
Change From Baseline in PASI Scores at Week 4 by Induction Dose
Time frame: Baseline (Day 1 pre-dose), Week 4
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16
Time frame: Weeks 1, 2, 4, 6, 8, 10, 14, 16
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16
Time frame: Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Time frame: Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of study treatment (Day 1) up to Week 20
Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs
Time frame: From first dose of study treatment (Day 1) up to Week 20
Change From Baseline in Blood Lipid Level at Weeks 4 and 12
Time frame: Baseline (Day 1 pre-dose), Weeks 4 and 12
Number of Participants With Any Post-Baseline Laboratory Test Abnormalities
Time frame: From first dose of study treatment (Day 1) up to Week 16
Number of Participants With Post-Baseline Vital Sign Abnormalities
Time frame: From first dose of study treatment (Day 1) up to Week 16
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Time frame: From first dose of study treatment (Day 1) up to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36045513Hughes 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.
- Derived from this study: PubMed 32311398Forman 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.
- Derived from this study: PubMed 30113844Fensome 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
44 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-06700841 in people with Chronic Plaque Psoriasis, run by Pfizer at 44 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Canada, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (time frame: Baseline (Day 1 pre-dose), Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02969018, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.