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

Chronic Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969018
• Other study ID #: B7931004
• Secondary ID: 2016-004049-96
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• PF-06700841

Other:
• Placebo

Locations

Country	Name	City	State
Canada	Lynderm Research Inc	Markham	Ontario
Canada	Research by ICLS	Oakville	Ontario
Canada	Skin Centre for Dermatology	Peterborough	Ontario
Canada	Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)	Quebec
Canada	The Centre for Dermatology	Richmond Hill	Ontario
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	K.Papp Clinical Research Inc.	Waterloo	Ontario
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
Poland	Centrum Badan Klinicznych PI-House Sp. z o.o.	Gdansk
Poland	Centrum Medyczne Enel-Med Przychodnia Grunwaldzka	Gdansk
Poland	Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak	Lodz
Poland	NZOZ "Nasz Lekarz" - Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna	Torun
Poland	MTZ Clinical Research Sp. z o.o.	Warszawa
Poland	WroMedica s.c.	Wroclaw
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Investigational Drug Services, UNC Hospitals	Chapel Hill	North Carolina
United States	UNC Clinical and Translation Research Center	Chapel Hill	North Carolina
United States	UNC Dermatology and Skin Cancer Center	Chapel Hill	North Carolina
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Center for Clinical Studies	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Dawes Fretzin Dermatology Group, LLC	Indianapolis	Indiana
United States	The Rockefeller University	New York	New York
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Park Avenue Dermatology	Orange Park	Florida
United States	Park Avenue Dermatology Administrative Annex	Orange Park	Florida
United States	Health Concepts	Rapid City	South Dakota
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA	Rogers	Arkansas
United States	Emil A. Tanghetti, MD dba Center for Dermatology and Laser Surgery	Sacramento	California
United States	Lee Medical Associates, PA	San Antonio	Texas
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Southern California Dermatology	Santa Ana	California
United States	Clinical Science Institute	Santa Monica	California
United States	Tower Saint John's Imaging	Santa Monica	California
United States	Premier Clinical Research	Spokane	Washington
United States	Forward Clinical Trials, Inc	Tampa	Florida
United States	Olympian Clinical Research	Tampa	Florida
United States	Rose Radiology	Tampa	Florida
United States	Vital Prospects Clinical Research Institute, P.C	Tulsa	Oklahoma
United States	Dundee Dermatology	West Dundee	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Day 1 pre-dose), Week 12
Secondary	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.	Week 12
Secondary	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.	Baseline (Day 1 pre-dose), Week 4
Secondary	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.	Weeks 1, 2, 4, 6, 8, 10, 14, 16
Secondary	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.	Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Secondary	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.	Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Secondary	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.	Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16
Secondary	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.	Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Secondary	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.	From first dose of study treatment (Day 1) up to Week 20
Secondary	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).	From first dose of study treatment (Day 1) up to Week 20
Secondary	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.	Baseline (Day 1 pre-dose), Weeks 4 and 12
Secondary	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).	From first dose of study treatment (Day 1) up to Week 16
Secondary	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.	From first dose of study treatment (Day 1) up to Week 16
Secondary	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.	From first dose of study treatment (Day 1) up to Week 16

External Links

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