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

NCT02201524 | Terminated Phase 2 Results

• 2 other identifiers: B7451005JAK-1 FOR PSORIASIS
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 45

Brief 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.

Conditions

Plaque Psoriasis

Keywords

Phase 2; randomized; double-blind; placebo; plaque; psoriasis; safety; efficacy; JAK; janus kinase; moderate; severe

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4

  PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).

  Baseline, Week 4

Secondary Outcomes (18)

• Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8

  Baseline, Week 1, 2, 3, 4, 5, 6, 8

• Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8

  Baseline, Week 1, 2, 3, 5, 6, 8

• Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8

  Baseline, Week 1, 2, 3, 4, 5, 6, 8

• Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8

  Baseline, Week 1, 2, 3, 4, 5, 6, 8

• Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8

  Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)

Study Arms (4)

Cohort 1

EXPERIMENTAL

200mg of PF-04965842 twice daily

Drug: PF-04965842

Cohort 2

EXPERIMENTAL

400mg of PF-04965842 once daily

Drug: PF-04965842

Cohort 3

EXPERIMENTAL

200mg of PF-04965842 once daily

Drug: PF-04965842

Cohort 4

PLACEBO COMPARATOR

Placebo comparator daily

Other: Placebo

Interventions

PF-04965842 DRUG

Subjects will receive 200 mg PF 04965842 twice daily for 4 weeks

Also known as: JAK1 inhibitor

Cohort 1

Placebo OTHER

Subjects will receive placebo for 4 weeks

Cohort 4

Eligibility Criteria

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

You may qualify if:

• Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose.
• Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose).
• Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose).
• Be a candidate for phototherapy or systemic treatment 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.
• \. 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.
• 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:
• weeks: etanercept (Enbrel).
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (45)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 32505, United States

Location

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

Rogers, Arkansas, 72758, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Dermatology Specialists, Inc.

Oceanside, California, 92056, United States

Location

Huntington Medical Foundation/Specialty Office

Pasadena, California, 91105, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Olympian Clinical Research

Clearwater, Florida, 33756, United States

Location

Westcoast Radiology Services

Clearwater, Florida, 33756, United States

Location

North Florida Dermatology Associates, PA

Jacksonville, Florida, 32204, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Park Avenue Dermatology, PA

Orange Park, Florida, 32073, United States

Location

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

Ormond Beach, Florida, 32174, United States

Location

Advanced Medical Research, Inc

Atlanta, Georgia, 30342, United States

Location

Columbus Dermatology, P.C.

Columbus, Georgia, 31904, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, 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

DS Research

Louisville, Kentucky, 40202, United States

Location

Shondra L Smith, MD

Lake Charles, Louisiana, 70605, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

Dartmouth-Hitchcock Medical Center - Section of Dermatology

Lebanon, New Hampshire, 03756, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Duke University Medical Center - Shipment Only

Durham, North Carolina, 27710, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

Dermatology Treatment & Research Center, PA

Dallas, Texas, 75230, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Virginia Clinical Research

Norfolk, Virginia, 23507, United States

Location

Premier Clinical Research

Spokane, Washington, 99202-1480, United States

Location

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

Location

Co-Medica Research Network Inc.

Courtice, Ontario, L1E 3C3, 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 & Cosmetic

Richmond Hill, Ontario, L4B 1A5, Canada

Location

K.Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

Dr Isabelle Delorme Inc.

Drummondville, Quebec, J2B 5L4, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Q & T Research Sherbrooke Inc.

Sherbrooke, Quebec, J1J 2G2, Canada

Location

Related Publications (3)

• Armstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19.

  PMID: 38896380 DERIVED

• Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11.

  PMID: 35342978 DERIVED

• Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.

  PMID: 35061234 DERIVED

Related Links

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

MeSH Terms

Conditions

Plaque, Amyloid; Psoriasis; Lymphoma, Follicular

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

The study was terminated early due to changes in the prioritization of the drug development portfolio and the early termination was not safety related.

Results Point of Contact

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

ClinicalTrials.gov_Inquires@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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 28, 2014
• Study Start: November 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 5, 2016
• Results First Posted: October 5, 2016

Record last verified: 2016-08

Locations

CA (10); US (35)