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

NCT02969018 | Completed Phase 2 Results

• 2 other identifiers: B79310042016-004049-96
• Study Type: interventional
• Target: 212
• Locations: 3 countries
• Sites: 44

Brief Summary

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

Keywords

plaque psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12

  Week 12

• Change From Baseline in PASI Scores at Week 4 by Induction Dose

  Baseline (Day 1 pre-dose), Week 4

• Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16

  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

  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

  Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

Study Arms (8)

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

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

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

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

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

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

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

Drug: PF-06700841

Placebo

PLACEBO COMPARATOR

12 weeks once daily placebo

Other: Placebo

Interventions

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

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (44)

Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA

Rogers, Arkansas, 72758, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Emil A. Tanghetti, MD dba Center for Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Location

Southern California Dermatology

Santa Ana, California, 92701, United States

Location

Tower Saint John's Imaging

Santa Monica, California, 90403, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Park Avenue Dermatology Administrative Annex

Orange Park, Florida, 32073, United States

Location

Park Avenue Dermatology

Orange Park, Florida, 32073, United States

Location

Olympian Clinical Research

Tampa, Florida, 33609, United States

Location

Rose Radiology

Tampa, Florida, 33609, United States

Location

Forward Clinical Trials, Inc

Tampa, Florida, 33624, United States

Location

Dundee Dermatology

West Dundee, Illinois, 60118, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Dawes Fretzin Dermatology Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

The Rockefeller University

New York, New York, 10065, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

Investigational Drug Services, UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

UNC Dermatology and Skin Cancer Center

Chapel Hill, North Carolina, 27516, United States

Location

UNC Clinical and Translation Research Center

Chapel Hill, North Carolina, 27599, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Vital Prospects Clinical Research Institute, P.C

Tulsa, Oklahoma, 74136, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Lee Medical Associates, PA

San Antonio, Texas, 78213, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X2, Canada

Location

Research by ICLS

Oakville, Ontario, L6J 7W5, Canada

Location

Skin Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

K.Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

Québec, Quebec, G1V4X7, Canada

Location

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Centrum Medyczne Enel-Med Przychodnia Grunwaldzka

Gdansk, 80-266, Poland

Location

Centrum Badan Klinicznych PI-House Sp. z o.o.

Gdansk, 80-546, Poland

Location

Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak

Lodz, 90-436, Poland

Location

NZOZ "Nasz Lekarz" - Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna

Torun, 87-100, Poland

Location

MTZ Clinical Research Sp. z o.o.

Warsaw, 02-106, Poland

Location

WroMedica s.c.

Wroclaw, 51-685, Poland

Location

Related Publications (3)

• 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.

  PMID: 36045513 DERIVED

• 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.

  PMID: 32311398 DERIVED

• 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.

  PMID: 30113844 DERIVED

Related Links

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

MeSH Terms

Interventions

PF-06700841

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 21, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 29, 2019
• Results First Posted: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

US (30); CA (8); PL (6)