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| ID | Type | Description | Link |
|---|---|---|---|
| C3291017 | Other Identifier | Alias Study Number |
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The purpose of this study is to determine whether AN2728 topical ointment is a safe and effective treatment for mild-to-moderate plaque-type psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AN2728 ointment, 2% | Experimental | AN2728 ointment, 2% |
|
| Ointment Vehicle | Placebo Comparator | Ointment Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN2728 ointment, 2% | Drug | AN2728 ointment, 2%, applied twice daily for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84 | PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 84. | Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70 | PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 14, 28, 42, 56 and 70. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Savin Center | New Haven | Connecticut | 06511 | United States | ||
| Dermatology Specialists, PSC |
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| ID | Title | Description |
|---|---|---|
| FG000 | AN2728 Ointment, 2% | AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator |
| FG001 | AN2728 Ointment, Vehicle | AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Intent-to-Treat (ITT) population included all randomized participants who received the study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | AN2728 Ointment, 2% | AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator. |
| BG001 | AN2728 Ointment, Vehicle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84 | PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 84. | ITT population included all randomized participants who received the study medication. Missing data was imputed using last observation carried forward (LOCF) method. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 84 |
|
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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 | AN2728 Ointment, 2% | AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis infective | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | 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 |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Ointment Vehicle |
| Drug |
Ointment Vehicle, applied twice daily for 12 weeks |
|
| Day 14, Day 28, Day 42, Day 56, Day 70 |
| Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84 | Percentage of the total body surface area (BSA) involved with psoriasis was measured. Change from Baseline (Day 1) in percentage of BSA at Day 84 was reported. | Baseline (Day 1), Day 84 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE. | Baseline (Day 1) up to Day 84 |
| Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild =AEs does not interfere with participant's usual function b) moderate =AEs interfered to some extent with participant's usual function c) severe =AEs interfered significantly with participant's usual function and required systemic drug therapy. Treatment-emergent were events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. In this outcome measure, number of mild, moderate and severe TEAEs were reported. | Baseline (Day 1) up to Day 84 |
| Number of Participants With Local Tolerability Symptoms: Burning/Stinging | Local tolerability in participants was evaluated in terms of presence and absence of burning/stinging symptom and its severity in the areas of body where medication was applied. Burning/stinging symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no stinging/ burning), 1 =mild (slight warm, tingling sensation), 2 = moderate (definite warm; tingling/stinging sensation), 3 = severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe burning/stinging symptoms were reported. | Baseline (Day 1) up to Day 84 |
| Number of Participants With Local Tolerability Symptoms: Pruritus | Local tolerability was evaluated in participants in terms of presence and absence of pruritus symptom and its severity in the areas of body where medication was applied. Pruritus symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no pruritus), 1 =mild (occasional, slight itching/scratching), 2 = moderate (constant or intermittent itching/scratching which was not disturbing sleep), 3 = severe (bothersome itching/scratching which was disturbing sleep). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe pruritus symptoms were reported. | Baseline (Day 1) up to Day 84 |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432-3133 | United States |
| Karl G. Heine, MD Dermatology | Henderson | Nevada | 89052 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| DermResearch, Inc | Austin | Texas | 78759 | United States |
| J&S Studies, Inc. | College Station | Texas | 77845 | United States |
| The Center for Skin Research | Houston | Texas | 77056 | United States |
| Protocol Violation |
|
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | AN2728 Ointment, 2% | AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator. |
| OG001 | AN2728 Ointment, Vehicle | AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator. |
|
|
|
| Secondary | Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70 | PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 14, 28, 42, 56 and 70. | ITT population included all randomized participants who received the study medication. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 14, Day 28, Day 42, Day 56, Day 70 |
|
|
|
| Secondary | Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84 | Percentage of the total body surface area (BSA) involved with psoriasis was measured. Change from Baseline (Day 1) in percentage of BSA at Day 84 was reported. | ITT population included all randomized participants who received the study medication. Missing data was imputed using LOCF method. | Posted | Mean | Standard Deviation | percentage of body surface area | Baseline (Day 1), Day 84 |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE. | Safety population included all randomized participants with confirmed usage of the study medication. | Posted | Number | participants | Baseline (Day 1) up to Day 84 |
|
|
|
| Secondary | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild =AEs does not interfere with participant's usual function b) moderate =AEs interfered to some extent with participant's usual function c) severe =AEs interfered significantly with participant's usual function and required systemic drug therapy. Treatment-emergent were events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. In this outcome measure, number of mild, moderate and severe TEAEs were reported. | Safety population included all randomized participants with confirmed usage of the study medication. | Posted | Number | adverse events | Baseline (Day 1) up to Day 84 |
|
|
|
| Secondary | Number of Participants With Local Tolerability Symptoms: Burning/Stinging | Local tolerability in participants was evaluated in terms of presence and absence of burning/stinging symptom and its severity in the areas of body where medication was applied. Burning/stinging symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no stinging/ burning), 1 =mild (slight warm, tingling sensation), 2 = moderate (definite warm; tingling/stinging sensation), 3 = severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe burning/stinging symptoms were reported. | Safety population included all randomized participants with confirmed usage of the study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline (Day 1) up to Day 84 |
|
|
|
| Secondary | Number of Participants With Local Tolerability Symptoms: Pruritus | Local tolerability was evaluated in participants in terms of presence and absence of pruritus symptom and its severity in the areas of body where medication was applied. Pruritus symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no pruritus), 1 =mild (occasional, slight itching/scratching), 2 = moderate (constant or intermittent itching/scratching which was not disturbing sleep), 3 = severe (bothersome itching/scratching which was disturbing sleep). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe pruritus symptoms were reported. | Safety population included all randomized participants with confirmed usage of the study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline (Day 1) up to Day 84 |
|
|
|
| 0 |
| 46 |
| 23 |
| 46 |
| EG001 | AN2728 Ointment, Vehicle | AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator. | 2 | 22 | 12 | 22 |
| Convulsion | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Application site rash | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Medical device pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Guttate psoriasis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
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.
| Day 42 |
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| Day 56 |
|
| Day 70 |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|