Phase 2 N=71 Randomized Double-blind Treatment

CP-690-550 Ointment For Chronic Plaque Psoriasis

Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT01246583 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 — -53.97; -41.01; -24.26; -17.24 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CP-690,550 Ointment 1 (Drug); Vehicle 1 (Drug); CP-690,550 Ointment 2 (Drug); Vehicle 2 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4	-53.97; -41.01; -24.26; -17.24	—
SECONDARY Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3	-31.00; -25.59; -12.65; -6.39; -46.32; -28.68	—
SECONDARY Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4	2.52; 2.62; 2.44; 2.50; -0.53; -0.77	—
SECONDARY Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of "Clear" (0) or "Almost Clear" (1)	42.11; 23.08; 21.74; 11.11; 52.38; 33.33	—
SECONDARY Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score	15.79; 0.00; 0.00; 0.00; 28.57; 8.33	—
SECONDARY Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4	-14.26; -11.26; -3.72; -3.50; -22.67; -8.35	—
SECONDARY Itch Severity Item (ISI)	4.09; 5.54; 4.36; 6.20; 2.63; 4.69	—
SECONDARY Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4	-1.47; -0.85; -0.74; -2.00; -1.90; -1.83	—
SECONDARY Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category	50.0; 23.1; 32.0; 0.0; 18.2; 38.5	—
SECONDARY Number of Participants With Administration Site Adverse Events	1; 0; 0; 0	—
SECONDARY Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area	0; 0; 0; 0; 1; 0	—
SECONDARY Number of Participants With Draize Score of Perilesional Skin in The Treatment Area	0; 0; 1; 0; 2; 2	—
SECONDARY Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4	77.91; 74.81; 75.52; 76.60; -3.18; -2.04	—
SECONDARY Change From Baseline in Heart Rate at Week 1, 2, 3, 4	67.24; 66.77; 66.12; 73.75; 2.21; 3.12	—
SECONDARY Change From Baseline in Electrocardiogram (ECG) Findings at Week 4	984.7; 958.4; 962.3; 887.9; -47.7; -21.5	—
SECONDARY Change From Baseline in Hemoglobin Level at Week 2, 4	14.56; 13.68; 14.21; 13.90; -0.20; 0.12	—
SECONDARY Change From Baseline in Platelet and Neutrophil Count at Week 2, 4	227.30; 212.85; 233.68; 214.90; 6.38; 6.85	—
SECONDARY Change From Baseline in Creatinine Level at Week 2, 4	1.00; 0.89; 0.93; 0.89; -0.02; -0.01	—
SECONDARY Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4	24.57; 22.77; 23.04; 21.10; -2.00; -1.23	—
SECONDARY Plasma Concentration of CP-690,550	0.1336; 0.0313; 0.1522; 0.0434; 0.1548; 0.0570	—

Summary

The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.

Eligibility Criteria

Inclusion Criteria

Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months;
A target plaque of at least 9 sq. cm.

Exclusion Criteria

Demonstrates "rebound" or "flare" of chronic plaque psoriasis;
Non plaque form of psoriasis;
Currently have or history of psoriatic arthritis;
Current drug induced psoriasis;
Currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months;
Currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01246583). 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.