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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A | Experimental |
| |
| Treatment Group B | Placebo Comparator |
| |
| Treatment Group C | Experimental |
| |
| Treatment Group D | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-690,550 Ointment 1 | Drug | 2% CP-690,550 Ointment 1 twice daily for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | Target plaque was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The individual signs severity sub scores were summed to calculate TPSS. The total score varied in increments of 1 and ranged from 1 to 12, with higher scores representing greater severity of psoriasis. | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Target plaque was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The individual signs severity sub scores were summed to calculate TPSS. The total score varied in increments of 1 and ranged from 1 to 12, with higher scores representing greater severity of psoriasis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horizon Research Group, Inc. | Mobile | Alabama | 36608 | United States | ||
| Dermatology Research Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23387374 | Derived | Ports WC, Khan S, Lan S, Lamba M, Bolduc C, Bissonnette R, Papp K. A randomized phase 2a efficacy and safety trial of the topical Janus kinase inhibitor tofacitinib in the treatment of chronic plaque psoriasis. Br J Dermatol. 2013 Jul;169(1):137-45. doi: 10.1111/bjd.12266. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2% CP-690,550 Ointment 1 | CP-690,550 2 percent (%) ointment 1, containing a dermal penetration agent, was applied topically to a 300 square centimeter (cm^2) treatment area twice daily at an application coverage of 3 milligram per cm^2 (mg/cm^2) for 4 weeks. |
| FG001 | Vehicle 1 | Placebo ointment (Vehicle 1), matched to 2% CP-690,550 ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks. |
| FG002 | 2% CP-690,550 Ointment 2 | CP-690,550 2% ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks. |
| FG003 | Vehicle 2 | Placebo ointment (Vehicle 2), matched to 2% CP-690,550 ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2% CP-690,550 Ointment 1 | CP-690,550 2% ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks. |
| BG001 | Vehicle 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | Target plaque was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The individual signs severity sub scores were summed to calculate TPSS. The total score varied in increments of 1 and ranged from 1 to 12, with higher scores representing greater severity of psoriasis. | Full analysis set (FAS) included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here Overall Number of Participants Analyzed signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 4 |
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2% CP-690,550 Ointment 1 | CP-690,550 2% ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
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| Vehicle 1 |
| Drug |
Vehicle 1 twice daily for 4 weeks |
|
| CP-690,550 Ointment 2 | Drug | 2% CP-690,550 Ointment 2 twice daily for 4 weeks |
|
| Vehicle 2 | Drug | Vehicle 2 twice daily for 4 weeks |
|
| Baseline, Weeks 1, 2, 3 |
| Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Target plaque severity was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. | Baseline, Weeks 1, 2, 3, 4 |
| Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of "Clear" (0) or "Almost Clear" (1) | Treatment area overall severity of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the treatment area according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. Total possible score range: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. | Week 1, 2, 3, 4 |
| Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Treatment area overall severity of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the treatment area according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. Total possible score: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. | Week 1, 2, 3, 4 |
| Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | A tracing of the target plaque on transparent film was used to quantify the target plaque area. The target plaque area was calculated by image analysis (planimetry). At baseline, target plaque area was determined prior to randomization to confirm the target plaque size of at least 9 cm^2. | Baseline, Week 1, 2, 3, 4 |
| Itch Severity Item (ISI) | The severity of itch was assessed using a single-item Patient Reported Outcome (PRO). Participants were asked to assess their worst itching due to psoriasis at the treatment area over the past 24 hours on a numeric rating scale ranging from of 0-10 where, 0=no itching and 10=worst possible itching. | Baseline, Week 1, 2, 3, 4 |
| Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | The severity of itch was assessed using a single-item PRO. Participants were asked to assess their worst itching due to psoriasis at the treatment area over the past 24 hours on a numeric rating scale ranging from of 0-10 where, 0=no itching and 10=worst possible itching. | Baseline, Week 1, 2, 3, 4 |
| Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | The PSSM evaluates overall participants satisfaction with the study treatment. Participants response evaluation was based on single 7-point item: 1=very satisfied, 2=somewhat satisfied, 3=slightly satisfied, 4=neither satisfied nor dissatisfied, 5=slightly dissatisfied, 6=somewhat dissatisfied, and 7=very dissatisfied. | Week 4 |
| Number of Participants With Administration Site Adverse Events | An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. Application site adverse event included documentation of any clinically significant local reaction, e.g erosion, vesicles or scabbing. | Baseline up to follow up visit (Day 36-39 after last dose of study treatment) (up to maximum of 9.5 weeks) |
| Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Burning/stinging symptoms at the treatment area including target plaque, additional plaque/s within the treatment area (if any) and treated perilesional skin (if any) were queried from the participants and scored by the investigator using a 4-point scale: 0=none; 1=Mild; 2=Moderate; 3=Severe. Except at baseline pre-dosing, burning/stinging was assessed for 2 time periods based on the maximum burning or stinging that the participant has experienced: Immediate (within 5 minutes after application); Persistent (beyond 5 minutes after application). | Baseline, Week 1, 2, 3, 4 |
| Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Draize scoring evaluated perilesional skin within treatment area for erythema and presence/absence of other signs and symptoms. Erythema score ranged from 0 to 4 as: 0(no reaction visible), 1(trace reactions- barely perceptible pinkness), 2(mild reaction- readily visible pinkness), 3(moderate reaction- definite redness), 4 (Strong to severe reaction- very intense redness). Letter grade defined as: J(Burning, stinging, itching), E(Edema), P(Papules), V(Vesicles), B(Bulla reaction), S(Spreading), W(Weeping), I(Induration), XC(Additional comments). Superficial observations defined as: G(Glazing), Y(Peeling), C(Scab), D(Hyperpigmentation), H(Hypopigmentation), F(Fissuring), R(Erosion), U(Ulceration), K(Scaling). Erythema and other signs/symptoms with at least 1 participant with Draize Score of Perilesional Skin in the treatment area were reported in this outcome measure. | Baseline, Week 1, 2, 3, 4 |
| Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Blood pressure (BP) was measured in duplicate (approximately 5 minutes apart) using a standard calibrated BP measuring device. BP defined as pressure exerted by circulating blood upon walls of blood vessels. Diastolic BP is minimum pressure in arteries, near beginning of cardiac cycle when ventricles are filled with blood. Systolic BP is peak pressure in arteries, near end of the cardiac cycle when ventricles are contracting. Normal blood pressure is less than 120 millimeters of mercury (mmHg) systolic and less than 80 mmHg diastolic. Change=value at week 1, 2, 3, 4 minus value at baseline. | Baseline, Week 1, 2, 3, 4 |
| Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Heart (pulse) rate was measured in duplicate (approximately 5 minutes apart) for a minimum of 30 seconds. Heart rate is the number of heartbeats per unit of time, usually per minute. The heart rate is based on the number of contractions of the ventricles (the lower chambers of the heart). Change=value at week 1, 2, 3, 4 minus value at baseline. | Baseline, Week 1, 2, 3, 4 |
| Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | A single standard supine 12-lead Electrocardiogram (ECG) was performed after the participant had rested quietly for at least 10 minutes. ECG parameters included RR interval, PR interval, QRS complex, QT interval, QTcB (corrected for heart rate using Bazett's formula) interval, and QTcF (corrected for heart rate using Fridericia's formula) interval. | Baseline, Week 4 |
| Change From Baseline in Hemoglobin Level at Week 2, 4 | Baseline, Week 2, 4 |
| Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Baseline, Week 2, 4 |
| Change From Baseline in Creatinine Level at Week 2, 4 | Baseline, Week 2, 4 |
| Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline, Week 2, 4 |
| Plasma Concentration of CP-690,550 | Summary statistics were calculated by setting concentration values below the lower limit of quantification (lower limit of quantification=0.1 nanogram per milliliter [ng/mL]) to zero. Summary statistics were not presented if number of observations above lower limit of quantification (NALQ) = 0. | 0 (predose), 1, 2 and 4-9 hours postdose on Day 29 or early termination |
| Los Angeles |
| California |
| 90045 |
| United States |
| Expresscare Medical | Los Angeles | California | 90045 | United States |
| Park Avenue Dermatology, PA | Orange Park | Florida | 32073 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Modern Research Associates, PLLC | Dallas | Texas | 75231 | United States |
| K.Papp Clinical Research Inc. | Waterloo | Ontario | N2J 1C4 | Canada |
| Innovaderm Research Inc | Montreal | Quebec | H2K 4L5 | Canada |
| Siena Medical Research | Montreal | Quebec | H3Z 2S6 | Canada |
| Centre de Recherche Dermatologique du Quebec metropolitain | Québec | Quebec | G1V 4X7 | Canada |
| Protocol Violation |
|
| Withdrawal by Subject |
|
Placebo ointment (Vehicle 1), matched to 2% CP-690,550 ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks.
| BG002 | 2% CP-690,550 Ointment 2 | CP-690,550 2% ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks. |
| BG003 | Vehicle 2 | Placebo ointment (Vehicle 2), matched to 2% CP-690,550 ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Vehicle 1 | Placebo ointment (Vehicle 1), matched to 2% CP-690,550 ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks. |
| OG002 | 2% CP-690,550 Ointment 2 | CP-690,550 2% ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks. |
| OG003 | Vehicle 2 | Placebo ointment (Vehicle 2), matched to 2% CP-690,550 ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks |
|
|
| Secondary | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Target plaque was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The individual signs severity sub scores were summed to calculate TPSS. The total score varied in increments of 1 and ranged from 1 to 12, with higher scores representing greater severity of psoriasis. | FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here Overall Number of Participants Analyzed= participants who were evaluable for this measure. Number Analyzed=participants evaluable for this measure at specified time points for each treatment group. | Posted | Mean | Standard Deviation | percent change | Baseline, Weeks 1, 2, 3 |
|
|
|
| Secondary | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Target plaque severity was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. | FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Number Analyzed=participants evaluable for this measure at specified time points for each treatment group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 1, 2, 3, 4 |
|
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| Secondary | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of "Clear" (0) or "Almost Clear" (1) | Treatment area overall severity of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the treatment area according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. Total possible score range: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. | FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here, Overall Number of Participants Analyzed= participants who were evaluable for this measure. Number Analyzed=participants evaluable for this measure at specified time points for each treatment group. | Posted | Number | percentage of participants | Week 1, 2, 3, 4 |
|
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|
| Secondary | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Treatment area overall severity of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the treatment area according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. Total possible score: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. | FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here, Overall Number of Participants Analyzed= participants who were evaluable for this measure. Number Analyzed=participants evaluable for this measure at specified time points for each treatment group. | Posted | Number | percentage of participants | Week 1, 2, 3, 4 |
|
|
|
| Secondary | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | A tracing of the target plaque on transparent film was used to quantify the target plaque area. The target plaque area was calculated by image analysis (planimetry). At baseline, target plaque area was determined prior to randomization to confirm the target plaque size of at least 9 cm^2. | FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here, Overall Number of Participants Analyzed= participants who were evaluable for this measure. Number Analyzed=participants evaluable for this measure at specified time points for each treatment group. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 1, 2, 3, 4 |
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| Secondary | Itch Severity Item (ISI) | The severity of itch was assessed using a single-item Patient Reported Outcome (PRO). Participants were asked to assess their worst itching due to psoriasis at the treatment area over the past 24 hours on a numeric rating scale ranging from of 0-10 where, 0=no itching and 10=worst possible itching. | FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Number Analyzed=participants evaluable for this measure at specified time points for each treatment group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, 2, 3, 4 |
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| Secondary | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | The severity of itch was assessed using a single-item PRO. Participants were asked to assess their worst itching due to psoriasis at the treatment area over the past 24 hours on a numeric rating scale ranging from of 0-10 where, 0=no itching and 10=worst possible itching. | FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here, Overall Number of Participants Analyzed=participants who were evaluable for this measure. Number Analyzed=participants evaluable for this measure at specified time points for each treatment group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, 2, 3, 4 |
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| Secondary | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | The PSSM evaluates overall participants satisfaction with the study treatment. Participants response evaluation was based on single 7-point item: 1=very satisfied, 2=somewhat satisfied, 3=slightly satisfied, 4=neither satisfied nor dissatisfied, 5=slightly dissatisfied, 6=somewhat dissatisfied, and 7=very dissatisfied. | FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this measure. | Posted | Number | percentage of participants | Week 4 |
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| Secondary | Number of Participants With Administration Site Adverse Events | An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. Application site adverse event included documentation of any clinically significant local reaction, e.g erosion, vesicles or scabbing. | Safety analysis set included all participants who received at least one dose of the investigational drug (CP-690,550 or vehicle). | Posted | Count of Participants | Participants | Baseline up to follow up visit (Day 36-39 after last dose of study treatment) (up to maximum of 9.5 weeks) |
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| Secondary | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Burning/stinging symptoms at the treatment area including target plaque, additional plaque/s within the treatment area (if any) and treated perilesional skin (if any) were queried from the participants and scored by the investigator using a 4-point scale: 0=none; 1=Mild; 2=Moderate; 3=Severe. Except at baseline pre-dosing, burning/stinging was assessed for 2 time periods based on the maximum burning or stinging that the participant has experienced: Immediate (within 5 minutes after application); Persistent (beyond 5 minutes after application). | FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). | Posted | Count of Participants | Participants | Baseline, Week 1, 2, 3, 4 |
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| Secondary | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Draize scoring evaluated perilesional skin within treatment area for erythema and presence/absence of other signs and symptoms. Erythema score ranged from 0 to 4 as: 0(no reaction visible), 1(trace reactions- barely perceptible pinkness), 2(mild reaction- readily visible pinkness), 3(moderate reaction- definite redness), 4 (Strong to severe reaction- very intense redness). Letter grade defined as: J(Burning, stinging, itching), E(Edema), P(Papules), V(Vesicles), B(Bulla reaction), S(Spreading), W(Weeping), I(Induration), XC(Additional comments). Superficial observations defined as: G(Glazing), Y(Peeling), C(Scab), D(Hyperpigmentation), H(Hypopigmentation), F(Fissuring), R(Erosion), U(Ulceration), K(Scaling). Erythema and other signs/symptoms with at least 1 participant with Draize Score of Perilesional Skin in the treatment area were reported in this outcome measure. | FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). | Posted | Count of Participants | Participants | Baseline, Week 1, 2, 3, 4 |
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| Secondary | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Blood pressure (BP) was measured in duplicate (approximately 5 minutes apart) using a standard calibrated BP measuring device. BP defined as pressure exerted by circulating blood upon walls of blood vessels. Diastolic BP is minimum pressure in arteries, near beginning of cardiac cycle when ventricles are filled with blood. Systolic BP is peak pressure in arteries, near end of the cardiac cycle when ventricles are contracting. Normal blood pressure is less than 120 millimeters of mercury (mmHg) systolic and less than 80 mmHg diastolic. Change=value at week 1, 2, 3, 4 minus value at baseline. | FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Number Analyzed=number of participants evaluable for this measure at specified time points for each treatment groups. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 1, 2, 3, 4 |
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| Secondary | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Heart (pulse) rate was measured in duplicate (approximately 5 minutes apart) for a minimum of 30 seconds. Heart rate is the number of heartbeats per unit of time, usually per minute. The heart rate is based on the number of contractions of the ventricles (the lower chambers of the heart). Change=value at week 1, 2, 3, 4 minus value at baseline. | FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Number Analyzed=participants evaluable for this measure at specified time points for each treatment groups. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Week 1, 2, 3, 4 |
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| Secondary | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | A single standard supine 12-lead Electrocardiogram (ECG) was performed after the participant had rested quietly for at least 10 minutes. ECG parameters included RR interval, PR interval, QRS complex, QT interval, QTcB (corrected for heart rate using Bazett's formula) interval, and QTcF (corrected for heart rate using Fridericia's formula) interval. | Safety analysis set included all participants who received at least one dose of the investigational drug (CP-690,550 or vehicle). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | milliseconds (msec) | Baseline, Week 4 |
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| Secondary | Change From Baseline in Hemoglobin Level at Week 2, 4 | FAS population included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (CP-690,550 or vehicle). Number Analyzed =participants evaluable for this measure at specified time points for each treatment group. | Posted | Mean | Standard Deviation | grams per deciliter (g/dL) | Baseline, Week 2, 4 |
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| Secondary | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | FAS population included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (CP-690,550 or vehicle). Number Analyzed =participants evaluable for this measure at specified time points for each treatment group. | Posted | Mean | Standard Deviation | 10^3 per cubic millimeter (10^3/mm^3) | Baseline, Week 2, 4 |
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| Secondary | Change From Baseline in Creatinine Level at Week 2, 4 | FAS population included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (CP-690,550 or vehicle). Number Analyzed=participants evaluable for this measure at specified time points for each treatment group. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | Baseline, Week 2, 4 |
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| Secondary | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | FAS population included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (CP-690,550 or vehicle). Number Analyzed=participants evaluable for this measure at specified time points for each treatment group. | Posted | Mean | Standard Deviation | international unit per liter (IU/L) | Baseline, Week 2, 4 |
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| Secondary | Plasma Concentration of CP-690,550 | Summary statistics were calculated by setting concentration values below the lower limit of quantification (lower limit of quantification=0.1 nanogram per milliliter [ng/mL]) to zero. Summary statistics were not presented if number of observations above lower limit of quantification (NALQ) = 0. | Pharmacokinetic analysis set included all treated participants who had at least one plasma concentration value above the lower limit of quantification. | Posted | Mean | Standard Deviation | ng/mL | 0 (predose), 1, 2 and 4-9 hours postdose on Day 29 or early termination |
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| 0 |
| 23 |
| 10 |
| 23 |
| EG001 | Vehicle 1 | Placebo ointment (Vehicle 1), matched to 2% CP-690,550 ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks. | 0 | 13 | 3 | 13 |
| EG002 | 2% CP-690,550 Ointment 2 | CP-690,550 2% ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks. | 0 | 25 | 9 | 25 |
| EG003 | Vehicle 2 | Placebo ointment (Vehicle 2), matched to 2% CP-690,550 ointment 2, without a dermal penetration agent, was applied topically to a 300 cm^2 treatment area twice daily at an application coverage of 3 mg/cm^2 for 4 weeks | 0 | 10 | 3 | 10 |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Application site erythema | General disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Eye infection viral | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Labyrinthitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Urinary tract infection staphylococcal | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
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| Electrocardiogram T wave inversion | Investigations | MedDRA 14.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Nerve compression | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Penis disorder | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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| Change at Week 2 |
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| Change at Week 3 |
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| Change at Week 1: Erythema |
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| Change at Week 2: Erythema |
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| Change at Week 3: Erythema |
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| Change at Week 4: Erythema |
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| Baseline: Induration |
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| Change at Week 1: Induration |
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| Change at Week 2: Induration |
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| Change at Week 3: Induration |
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| Change at Week 4: Induration |
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| Baseline: Scaling |
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| Change at Week 1: Scaling |
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| Change at Week 2: Scaling |
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| Change at Week 3: Scaling |
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| Change at Week 4: Scaling |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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| Change at Week 2 |
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| Change at Week 3 |
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| Change at Week 4 |
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| Week 1 |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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| Change at Week 2 |
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| Change at Week 3 |
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| Change at Week 4 |
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| Somewhat Satisfied |
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| Slightly Satisfied |
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| Neither Satisfied nor Dissatisfied |
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| Slightly Dissatisfied |
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| Somewhat Dissatisfied |
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| Very Dissatisfied |
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| Baseline: Mild, Immediate Stinging/Burning |
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| Baseline: Moderate, Immediate Stinging/Burning |
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| Baseline: Severe, Immediate Stinging/Burning |
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| Baseline: None, Persistent Stinging/Burning |
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| Baseline: Mild, Persistent Stinging/Burning |
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| Baseline: Moderate, Persistent Stinging/Burning |
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| Baseline: Severe, Persistent Stinging/Burning |
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| Week 1: None, Immediate Stinging/Burning |
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| Week 1: Mild, Immediate Stinging/Burning |
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| Week 1: Moderate, Immediate Stinging/Burning |
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| Week 1: Severe, Immediate Stinging/Burning |
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| Week 2: None, Immediate Stinging/Burning |
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| Week 2: Mild, Immediate Stinging/Burning |
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| Week 2: Moderate, Immediate Stinging/Burning |
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| Week 2: Severe, Immediate Stinging/Burning |
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| Week 3: None, Immediate Stinging/Burning |
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| Week 3: Mild, Immediate Stinging/Burning |
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| Week 3: Moderate, Immediate Stinging/Burning |
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| Week 3: Severe, Immediate Stinging/Burning |
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| Week 4: None, Immediate Stinging/Burning |
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| Week 4: Mild, Immediate Stinging/Burning |
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| Week 4: Moderate, Immediate Stinging/Burning |
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| Week 4: Severe, Immediate Stinging/Burning |
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| Week 1: None, Persistent Stinging/Burning |
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| Week 1: Mild, Persistent Stinging/Burning |
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| Week 1: Moderate, Persistent Stinging/Burning |
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| Week 1: Severe, Persistent Stinging/Burning |
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| Week 2: None, Persistent Stinging/Burning |
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| Week 2: Mild, Persistent Stinging/Burning |
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| Week 2: Moderate, Persistent Stinging/Burning |
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| Week 2: Severe, Persistent Stinging/Burning |
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| Week 3: None, Persistent Stinging/Burning |
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| Week 3: Mild, Persistent Stinging/Burning |
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| Week 3: Moderate, Persistent Stinging/Burning |
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| Week 3: Severe, Persistent Stinging/Burning |
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| Week 4: None, Persistent Stinging/Burning |
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| Week 4: Mild, Persistent Stinging/Burning |
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| Week 4: Moderate, Persistent Stinging/Burning |
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| Week 4: Severe, Persistent Stinging/Burning |
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| Baseline, Letter Grade: Burning, Stinging, Itching |
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| Baseline,Superficial Observation:Hyperpigmentation |
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| Baseline,Superficial Observation: Scaling-Flacking |
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| Baseline, Superficial Observation: Glazing |
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| Week 1, Erythema: Trace Reaction |
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| Week 1, Erythema: Moderate Reaction |
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| Week 1, Letter Grade: Burning, Stinging, Itching |
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| Week 1, Superficial Observation: Peeling |
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| Week 1, Superficial Observation: Scaling-Flacking |
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| Week 2, Erythema: Trace Reaction |
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| Week 2, Letter Grade: Burning, Stinging, Itching |
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| Week 2, Superficial Observation: Scaling-Flacking |
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| Week 3, Erythema: Trace Reaction |
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| Week 3, Letter Grade: Burning, Stinging, Itching |
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| Week 4, Superficial Observation: Hyperpigmentation |
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| Change at Week 1: Diastolic BP |
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| Change at Week 2: Diastolic BP |
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| Change at Week 3: Diastolic BP |
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| Change at Week 4: Diastolic BP |
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| Baseline: Systolic BP |
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| Change at Week 1: Systolic BP |
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| Change at Week 2: Systolic BP |
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| Change at Week 3: Systolic BP |
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| Change at Week 4: Systolic BP |
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| Change at Week 1 |
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| Change at Week 2 |
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| Change at Week 3 |
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| Change at Week 4 |
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| Change at Week 4: RR Interval |
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| Baseline: PR Interval |
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| Change at Week 4: PR Interval |
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| Baseline: QRS Complex |
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| Change at Week 4: QRS Complex |
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| Baseline: QT Interval |
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| Change at Week 4: QT Interval |
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| Baseline: QTcB Interval |
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| Change at Week 4: QTcB Interval |
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| Baseline: QTcF Interval |
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| Change at Week 4: QTcF Interval |
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| Change at Week 2 |
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| Change at Week 4 |
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| Change at Week 2: Platelet |
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| Change at Week 4: Platelet |
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| Baseline: Neutrophil |
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| Change at Week 2: Neutrophil |
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| Change at Week 4: Neutrophil |
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| Change at Week 2 |
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| Change at Week 4 |
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| Change at Week 2: AST |
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| Change at Week 4: AST |
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| Baseline: ALT |
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| Change at Week 2: ALT |
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| Change at Week 4: ALT |
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| Baseline: CK |
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| Change at Week 2: CK |
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| Change at Week 4: CK |
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| 2 hours |
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| 4 hours |
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