Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor Decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing of AMG 827 for up to 362 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 827 | Experimental | AMG 827 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 827 | Drug | 210 mg SC or 140 mg SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1) | Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1) | 264 weeks |
| Percent Change in Psoriasis Area and Severity Index (PASI) | Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement. | 264 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Newnan | Georgia | 30263 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25313095 | Background | Papp K, Leonardi C, Menter A, Thompson EH, Milmont CE, Kricorian G, Nirula A, Klekotka P. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014 Dec;71(6):1183-1190.e3. doi: 10.1016/j.jaad.2014.08.039. Epub 2014 Oct 11. | |
| 32207067 | Derived | Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Open Label AMG 827 | AMG 827: 210 mg SC or 140 mg SC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Skokie |
| Illinois |
| 60077 |
| United States |
| Research Site | St Louis | Missouri | 63117 | United States |
| Research Site | Albuquerque | New Mexico | 87106 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Webster | Texas | 77598 | United States |
| Research Site | Kogarah | New South Wales | 2217 | Australia |
| Research Site | Adelaide | South Australia | 5000 | Australia |
| Research Site | Parkville | Victoria | 3050 | Australia |
| Research Site | Prahran | Victoria | 3181 | Australia |
| Research Site | Hamilton | Ontario | L8N 1V6 | Canada |
| Research Site | London | Ontario | N6A 3H7 | Canada |
| Research Site | Markham | Ontario | L3P 1A8 | Canada |
| Research Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Research Site | Windsor | Ontario | N8W 1E6 | Canada |
| Research Site | Québec | Quebec | G1V 4X7 | Canada |
| Research Site | Aarhus | 8000 | Denmark |
| Research Site | Hellerup | 2900 | Denmark |
| Research Site | Besançon | 25030 | France |
| Research Site | Nice | 06200 | France |
| Research Site | Toulouse | 31059 | France |
| 31493163 | Derived | Lebwohl MG, Blauvelt A, Menter A, Papp KA, Guenthner S, Pillai R, Israel RJ, Jacobson A. Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study. Am J Clin Dermatol. 2019 Dec;20(6):863-871. doi: 10.1007/s40257-019-00466-2. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Open Label | AMG 827: 210 mg SC or 140 mg SC |
| 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 | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1) | Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1) | Subjects who were enrolled and had a valid measurement value at the specified week. Results are presented for data up to week 264 as all continuing subjects had completed that visit. | Posted | Count of Participants | Participants | 264 weeks |
|
|
| ||||||||||||||||||||||||||
| Primary | Percent Change in Psoriasis Area and Severity Index (PASI) | Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement. | Subjects who were enrolled and had a valid measurement value at the specified week. Results are presented for data up to week 264 as all continuing subjects had completed that visit. | Posted | Mean | Standard Deviation | Percentage change | 264 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label AMG 827 | AMG 827: 210 mg SC or 140 mg SC | 1 | 181 | 29 | 181 | 177 | 181 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial Infaraction | Cardiac disorders | Non-systematic Assessment |
| ||
| Hepatitis C | Infections and infestations | Non-systematic Assessment |
| ||
| Meningitis Viral | Infections and infestations | Non-systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Non-systematic Assessment |
| ||
| Pyelonephritis acute | Infections and infestations | Non-systematic Assessment |
| ||
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Duodenal Ulcer | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pustular Psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Toxic Skin Eruptions | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Lower Limb Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Cervical Radiculopathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Non-systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Necrotising fascitis streptococcal | Infections and infestations | Non-systematic Assessment |
| ||
| Septic Shock | Infections and infestations | Non-systematic Assessment |
| ||
| Urosepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Gastroenteritis eosinophillic | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Intervertabral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bile duct stone | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Cholecystitis acute | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Aortic aneurysm rupture | Vascular disorders | Non-systematic Assessment |
| ||
| Femoral artery occlusion | Vascular disorders | Non-systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | General disorders | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Hypertension | Nervous system disorders | Non-systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle strain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | General disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Tendonitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pharyngitis streptococcal | Infections and infestations | Non-systematic Assessment |
| ||
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Insomnia | General disorders | Non-systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Viral upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lindsey Mathew | Valeant Pharmaceuticals International | 908 | lindsey.mathew@valeant.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571216 | brodalumab |
Not provided
Not provided
Not provided
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|