Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled Study To Evaluate Safety And Efficacy Of Pf-04965842 In Subjects With Moderate To Severe Psoriasis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02201524
• Other study ID #: B7451005
• Secondary ID: JAK-1 FOR PSORIA
• Status: Terminated
• Phase: Phase 2
• First received: July 24, 2014
• Last updated: December 4, 2015
• Start date: November 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842 in patients with moderate to severe psoriasis. The study will include three PF-04965842 groups (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The treatment period will be 4 weeks in duration and will be followed up by a 4 week follow up period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose.

2. Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose).

3. Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose).

4. Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).

Exclusion Criteria:

1. Currently have non plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis.

2. 3. Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium.

3. Have received any of the following treatment regimens specified in the timeframes outlined below:

Within 9 months of first dose of study drug:

• Ustekinumab (Stelara).

Within 12 weeks of first dose of study drug:

• Any experimental therapy for psoriasis or rheumatoid arthritis.

Within 4 8 weeks of first dose of study drug:

• Biologic therapies for psoriasis have discontinuation periods determined from approximately 5x half life of the respective biologic:

• 4 weeks: etanercept (Enbrel).

• 8 weeks: infliximab (Remicade), adalimumab (Humira).

Within 4 weeks of first dose of study drug:

• Systemic treatments other than biologics that could affect psoriasis (eg, oral or injectable corticosteroids, retinoids, methotrexate, cyclosporine, fumaric acid derivatives, sulfasalazine, hydroxycarbamide (hydroxyurea), azathioprine).

• Phototherapy and psoralen plus ultraviolet A therapy (PUVA).

• Other - intramuscular gold, immunization with any live virus vaccination (eg, FluMist), herbal medications.

Within 2 weeks of first dose of study drug:

• Topical treatments that could affect psoriasis (eg, corticosteroids, tars, keratolytics, anthralin, vitamin D analogs, and retinoids).

• Phototherapy with ultraviolet B (UVB) (narrowband or broadband).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• PF-04965842
Subjects will receive 200 mg PF 04965842 twice daily for 4 weeks
• PF-04965842
Subjects will receive 400 mg PF 04965842 daily for 4 weeks
• PF-04965842
Subjects will receive 200 mg PF 04965842 daily for 4 weeks

Other:
• Placebo
Subjects will receive placebo for 4 weeks

Locations

Country	Name	City	State
Canada	Co-Medica Research Network Inc.	Courtice	Ontario
Canada	Courtice Health Centre Imaging/Courtice Health Centre	Courtice	Ontario
Canada	Dr Isabelle Delorme Inc.	Drummondville	Quebec
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	Research by ICLS	Oakville	Ontario
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	The Centre for Dermatology & Cosmetic	Richmond Hill	Ontario
Canada	Q & T Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Enverus Medical Research	Surrey	British Columbia
Canada	K.Papp Clinical Research Inc.	Waterloo	Ontario
United States	Arlington Research Center, Inc.	Arlington	Texas
United States	Advanced Medical Research, Inc	Atlanta	Georgia
United States	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama
United States	Olympian Clinical Research	Clearwater	Florida
United States	Westcoast Radiology Services	Clearwater	Florida
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Dermatology Treatment & Research Center, PA	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Duke University Medical Center - Shipment Only	Durham	North Carolina
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Dermatology Consulting Services	High Point	North Carolina
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	North Florida Dermatology Associates, PA	Jacksonville	Florida
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Shondra L Smith, MD	Lake Charles	Louisiana
United States	Dartmouth-Hitchcock Medical Center - Section of Dermatology	Lebanon	New Hampshire
United States	Dermatology Research Associates	Los Angeles	California
United States	DS Research	Louisville	Kentucky
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Mount Sinai Medical Center	New York	New York
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Park Avenue Dermatology, PA	Orange Park	Florida
United States	Leavitt Medical Associates of Florida d/b/a Ameriderm Research	Ormond Beach	Florida
United States	Huntington Medical Foundation/Specialty Office	Pasadena	California
United States	Health Concepts	Rapid City	South Dakota
United States	Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA	Rogers	Arkansas
United States	Clinical Science Institute	Santa Monica	California
United States	Premier Clinical Research	Spokane	Washington
United States	Dundee Dermatology	West Dundee	Illinois
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Psoriasis area severity index (PASI) score at Week 4.	PASI score: Quantification of lesion severity (erythema, induration, scaling) and percentage of body surface area affected.	4 weeks	Yes
Secondary	Percent change from baseline in PASI scores over time.	PASI score: Quantification of lesion severity (erythema, induration, scaling) and percentage of body surface area affected.	8 weeks	No
Secondary	Change from baseline in PASI scores over time.	PASI score: Quantification of lesion severity (erythema, induration, scaling) and percentage of body surface area affected.	8 weeks	No
Secondary	Proportions of subjects achieving 50%, 75% and 90% reduction from baseline PASI over time.	PASI score: Quantification of lesion severity (erythema, induration, scaling) and percentage of body surface area affected.	8 weeks	No
Secondary	Proportions of subjects with Physician Global Assessment (PGA) of "clear" or "almost clear" over time.	PGA: A 5 point scale assessing erythema, induration and scaling	8 weeks	No
Secondary	Change from baseline in clinical laboratory values (fasting lipids)	Cholesterol, HDL, LDL, Triglycerides	8 weeks	Yes
Secondary	Change from baseline in clinical laboratory values (lipid ratios)	LDL/HDL ratio	8 weeks	Yes
Secondary	Change from baseline in clinical laboratory values (hsC-reactive protein (CRP)	hsCRP: Marker of inflammation	8 weeks	Yes
Secondary	Change from baseline in clinical laboratory values (Epstein-Barr virus (EBV))	EBV viral load	8 weeks	Yes
Secondary	Change from baseline in clinical laboratory values (cytomegalovirus (CMV))	CMV viral load	8 weeks	Yes
Secondary	Change from baseline in clinical laboratory values (herpes simplex virus deoxyribonucleic acid (HSV DNA))	HSV viral load	8 weeks	Yes
Secondary	Change from baseline in vital signs (blood pressure)	Measurement of diastolic and systolic blood pressure	8 weeks	Yes
Secondary	Change from baseline in vital signs (pulse rate)	Measurement of heart rate	8 weeks	Yes
Secondary	Change from baseline in vital signs (oral or tympanic temperature measurements)	Measurement of temperature	8 weeks	Yes
Secondary	Change from baseline in electrocardiogram (ECG) parameters (heart rate).	Measurement of ECG parameters	8 weeks	Yes
Secondary	Change from baseline in electrocardiogram (ECG) parameters (QT intervals)	Measurement of ECG parameters	8 weeks	Yes
Secondary	Change from baseline in electrocardiogram (ECG) parameters (QTc intervals).	Measurement of ECG parameters	8 weeks	Yes
Secondary	Change from baseline in electrocardiogram (ECG) parameters (PR intervals)	Measurement of ECG parameters	8 weeks	Yes
Secondary	Change from baseline in electrocardiogram (ECG) parameters (QRS intervals)	Measurement of ECG parameters	8 weeks	Yes
Secondary	• Change from baseline in vital signs (respiratory rate)	Measurement of respiratory rate	8 weeks	Yes

External Links

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