Phase 2 N=178 Randomized Double-blind Treatment

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

Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT03895372 ↗

Enrolled (actual)

178

Serious AEs

3.4%

Results posted

Aug 2021

Primary outcome: Primary: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period — 0; 0; 0; 0 Percentage of participants — p=0.2621

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PF-06826647 or Placebo (Drug); PF-06826647 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: May 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period	0; 0; 0; 0; 0; 0	0.2621
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period	11; 8; 7; 6; 7; 7	—
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period	4; 3; 2; 3; 0; 1	—
PRIMARY Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period	0; 1; 0; 0; 0; 0	—
PRIMARY Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period	0; 0; 0; 0; 1; 0	—
PRIMARY Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period	0; 1; 0; 0; 0; 0	—
SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period	0; 0; 0; 2.2; 0; 4.8	—
SECONDARY 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	2.4; 0; 4.8; 4.4; 4.9; 2.4	—
SECONDARY Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period	2.4; 0; 4.8; 4.4; 4.9; 2.4	—
SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period	2.4; 0; 4.8; 11.4; 5.0; 7.1	—
SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period	0; 0; 0; 0; 0; 0	—
SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period	-1.88; -2.82; -1.96; -4.32; -3.00; -3.44	—
SECONDARY Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period	-5.63; -9.42; -8.93; -17.41; -12.55; -16.18	—
SECONDARY Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period	-0.60; 0.05; -0.64; -0.76; -0.41; -0.71	—
SECONDARY Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period	7.1; 0; 4.8; 6.7; 12.2; 7.1	—
SECONDARY Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period	-1.51; -0.89; -1.98; -2.54; -1.25; -2.70	—
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period	23; 13; 16; 28; 29; 0	—
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period	4; 0; 4; 11; 8; 0	—
SECONDARY Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period	1; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period	0; 0; 0; 0; 1; 4	—
SECONDARY Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period	0; 0; 0; 2; 3; 0	—
SECONDARY Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period	0; 0; 0; 0; 0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

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).

Exclusion Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03895372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.