A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis

NCT03895372 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: C25010042018-004669-16
• Study Type: interventional
• Target: 179
• Locations: 4 countries
• Sites: 45

Brief Summary

This multicenter study is being conducted to provide additional PF-06826647 safety and tolerability data, and to further explore the clinical efficacy of PF-06826647 in the treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to enable selection of oral dose and dosing regimen for the future clinical development of PF-06826647.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period

  The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. The statistical analysis was for the data at Week 16.

  Baseline up to Week 16

• Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period

  An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (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. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time.

  From Week 16 to Week 40

• Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period

  Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious AE (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. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

  From Week 16 to Week 40

• Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

  Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, prothrombin international (Intl.) normalized ratio, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal.

  From Week 16 to Week 40

• Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

  Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol.

  From Week 16 to Week 40

• Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

  Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria.

  From Week 16 to Week 40

• Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period

  Criteria for ECG abnormalities: maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 milliseconds (msec) and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, a maximum IFB: Pctchg\>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to \<=480 msec, 480 msec to \<=500 msec and a maximum change of \<30 change =\<60 or \>60 msec from baseline.

  From Week 16 to Week 40

• Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period

  The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: sitting diastolic blood pressure (BP) \< 50 millimeter of mercury (mmHg), sitting diastolic BP change \>= 20 mmHg increase, sitting diastolic BP change \>= 20 mmHg decrease, sitting systolic BP \< 90 mmHg, sitting systolic BP change \>= 30 mmHg increase, and sitting systolic BP change \>= 30 mmHg decrease.

  From Week 16 to Week 40

Secondary Outcomes (17)

• Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period

  Baseline up to Week 16

• Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period

  Baseline up to Week 16

• Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period

  Baseline up to Week 16

• Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period

  Baseline up to Week 16

• Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period

  Baseline up to Week 16

Study Arms (5)

PF-06826647 Drug Dose Level 1

EXPERIMENTAL

Delivered orally for 16 weeks during the Investigational Treatment Period

Drug: PF-06826647 or Placebo

PF-06826647 Placebo

EXPERIMENTAL

Delivered orally for 16 weeks during the Investigational Treatment Period

Drug: PF-06826647 or Placebo

PF-06826647 Drug Dose Level 2

EXPERIMENTAL

Delivered orally for 16 weeks during the Investigational Treatment Period

Drug: PF-06826647 or Placebo

PF-06826647 Drug Dose Level 3

EXPERIMENTAL

Delivered orally for 16 weeks during the Investigational Treatment Period then 24 weeks in Extension Period.

Drug: PF-06826647 or Placebo; Drug: PF-06826647

PF-06826647 Drug Dose Level 4

EXPERIMENTAL

Delivered orally for 16 weeks then for 24 weeks in Extension Period.

Drug: PF-06826647 or Placebo; Drug: PF-06826647

Interventions

PF-06826647 or Placebo DRUG

Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period

PF-06826647 Drug Dose Level 1; PF-06826647 Drug Dose Level 2; PF-06826647 Drug Dose Level 3; PF-06826647 Drug Dose Level 4; PF-06826647 Placebo

PF-06826647 DRUG

Delivered orally (tablet) once daily (QD) for 24 weeks during the Extension Period

PF-06826647 Drug Dose Level 3; PF-06826647 Drug Dose Level 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between the ages of 18 and 75 years.
• Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months.
• Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3 (moderate) or 4 (severe).
• Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).

You may not qualify if:

• Have non-plaque forms of psoriasis.
• Drug-induced psoriasis.
• Current active infection.
• Infected with Mycobacterium tuberculosis (TB).
• Have any history of malignancies.
• Require treatment with prohibited concomitant medications(s).
• Positive for hepatitis B or C, or human immunodeficiency virus (HIV).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (45)

Alliance Dermatology and Mohs Center

Phoenix, Arizona, 85032, United States

Location

Center for Dermatology and Plastic Surgery/CCT

Scottsdale, Arizona, 85260, United States

Location

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona, 85260, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Kern Research. Inc.

Bakersfield, California, 93301, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Imaging Healthcare Specialists

San Diego, California, 92103, United States

Location

Medderm Associates Dermatology

San Diego, California, 92103, United States

Location

University Clinical Trials

San Diego, California, 92123, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

MidState Skin Institute

Ocala, Florida, 34471, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Advanced Diagnostic Group

Orange Park, Florida, 32073, United States

Location

Park Avenue Dermatology

Orange Park, Florida, 32073, United States

Location

Leavitt Medical Associates of Florida d/b/a Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Hamilton Research, LLC

Alpharetta, Georgia, 30022, United States

Location

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, 66215, United States

Location

Qualmedica Research, LLC

Owensboro, Kentucky, 42301, United States

Location

Owensboro Dermatology Associates

Owensboro, Kentucky, 42303, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70809, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70816, United States

Location

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

SKiN Health

Cobourg, Ontario, K9A 0Z4, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1Y2, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

Toronto Research Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Centre Radiologique de l'Estrie

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Teikyo University Hospital

Itabashi-ku, Tokyo, 173-8606, Japan

Location

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Seibo International Catholic Hospital

Shinjuku-ku, Tokyo, 161-8521, Japan

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Malopolskie Centrum Medyczn

Krakow, Lesser Poland Voivodeship, 30-510, Poland

Location

MTZ Clinical Research Sp. z o.o.

Warsaw, Masovian Voivodeship, 02-106, Poland

Location

Zdrowie Osteo-Medic s.c. L. i A. Racewicz, A. i J. Supronik

Bialystok, Podlaskie Voivodeship, 15-351, Poland

Location

SpecDerm Poznanska Sp. J.

Bialystok, 15-375, Poland

Location

Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

Kielce, 25-316, Poland

Location

Pratia MCM Krakow

Krakow, 30-510, Poland

Location

Tomasz Blicharski Lubelskie Centrum Diagnostyczne

Swidnik, Lubelskie, 21-040, Poland

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Psoriasis

Interventions

ropsacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 29, 2019
• Study Start: June 27, 2019
• Primary Completion: May 21, 2020
• Study Completion: November 26, 2020
• Last Updated: August 27, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (7); US (24); JP (6); CA (8)