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The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12. Subjects were randomized ina 1:1:1:1:1 ratio. Subjects randomized to receive AMG 827 received 70, 140, or 210 mg at day 1 and weeks 4 and 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 140 mg SC | Experimental | 140 mg SC |
|
| 70 mg SC | Experimental | 70 mg SC |
|
| 280 mg SC | Experimental | 280 mg SC |
|
| 210 mg SC | Placebo Comparator | 210 mg SC |
|
| Placebo | Experimental | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 70 mg SC | Drug | 70 mg SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12. At the baseline of the study the subject would need to have at least a 10% BSA; at week 12 they were again assessed to see what change in percentage of BSA has occurred. | Baseline and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24079852 | Background | Gordon KB, Kimball AB, Chau D, Viswanathan HN, Li J, Revicki DA, Kricorian G, Ortmeier BG. Impact of brodalumab treatment on psoriasis symptoms and health-related quality of life: use of a novel patient-reported outcome measure, the Psoriasis Symptom Inventory. Br J Dermatol. 2014 Mar;170(3):705-15. doi: 10.1111/bjd.12636. | |
| 22455412 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 210 mg | AMG 827: 210 mg SC |
| FG001 | 140 mg | AMG 827: 140 mg SC |
| FG002 | 280 mg | AMG 827: 280 mg SC |
| FG003 | Placebo | Placebo: Placebo SC |
| FG004 | 70 mg | AMG 827: 70 mg SC |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Broda 210 mg | AMG 827: 210 mg SC |
| BG001 | Broda 140 mg | AMG 827: 140 mg SC |
| BG002 |
| 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 | Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score. | Posted | Mean | Standard Deviation | percentage of psoriasis improvement | Baseline and 12 weeks |
|
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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 | Broda 210 mg | AMG 827: 210 mg SC |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Erythema | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Valeant Pharmaceuticals | 908 | binu.alexander@valeant.com |
| 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 |
|---|---|
| C571216 | brodalumab |
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| 210 mg SC |
| Drug |
210 mg SC |
|
|
| 140 mg SC | Drug | 140 mg SC |
|
|
| 280 mg SC | Drug | 280 mg SC |
|
|
| Placebo | Drug | Placebo SC |
|
| Papp KA, Leonardi C, Menter A, Ortonne JP, Krueger JG, Kricorian G, Aras G, Li J, Russell CB, Thompson EH, Baumgartner S. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med. 2012 Mar 29;366(13):1181-9. doi: 10.1056/NEJMoa1109017. |
| 25553889 | Background | Papp K, Menter A, Strober B, Kricorian G, Thompson EH, Milmont CE, Nirula A, Klekotka P. Efficacy and safety of brodalumab in subpopulations of patients with difficult-to-treat moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2015 Mar;72(3):436-439.e1. doi: 10.1016/j.jaad.2014.10.026. Epub 2014 Dec 29. |
| 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. |
| 25313095 | Derived | 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. |
| Broda 280 mg |
AMG 827: 280 mg SC |
| BG003 | Placebo | Placebo: Placebo SC |
| BG004 | Broda 70 mg | AMG 827: 70 mg SC |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Broda 280 mg |
AMG 827: 280 mg SC |
| OG003 | Placebo | Placebo: Placebo SC |
| OG004 | Broda 70 mg | AMG 827: 70 mg SC |
|
|
| Secondary | Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12. At the baseline of the study the subject would need to have at least a 10% BSA; at week 12 they were again assessed to see what change in percentage of BSA has occurred. | Posted | Mean | Standard Deviation | percentage improvement in BSA | Baseline and Week 12 |
|
|
|
| 1 |
| 40 |
| 15 |
| 40 |
| EG001 | Broda 140 mg | AMG 827: 140 mg SC | 0 | 39 | 12 | 39 |
| EG002 | Broda 280 mg | AMG 827: 280 mg SC | 0 | 42 | 10 | 42 |
| EG003 | Placebo | Placebo: Placebo SC | 0 | 38 | 7 | 38 |
| EG004 | Broda 70 mg | AMG 827: 70 mg SC | 0 | 39 | 10 | 39 |
| Injection Site Pain | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Injection Site Induration | General disorders | Non-systematic Assessment |
|
| Injection Site Swelling | General disorders | Non-systematic Assessment |
|
| Injection Site Pruritus | General disorders | Non-systematic Assessment |
|
| Injection Site Hematoma | General disorders | Non-systematic Assessment |
|
| Injection Site Uticaria | General disorders | Non-systematic Assessment |
|
| Injection Site Warmth | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Abscess Limb | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Herpes Zoster | Infections and infestations | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Oral Herpes | Infections and infestations | Non-systematic Assessment |
|
| Pharnyngitis | Infections and infestations | Non-systematic Assessment |
|
| Sinustitis | Infections and infestations | Non-systematic Assessment |
|
| Viral Infection | Infections and infestations | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Mechanical Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash Morbilliform | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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