Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo treatment |
|
| 140 mg SC | Experimental | 140 mg SC PsO |
|
| 350 mg SC | Active Comparator | 350 mg SC PsO |
|
| 700 mg IV | Experimental | 700 mg IV PsO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 700 mg IV | Drug | single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43 | Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease. | Through day 43 |
| Part B: All Treatment Adverse Events Reported for Safety Evaluation | This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period. | 85 days |
| Part A: All Treatment Adverse Events Reported for Safety Evaluation | This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period. | Cohort 1-4 43 days, Cohort 5-8 64 days |
Not provided
Not provided
Inclusion Criteria:
Part A:
Part B:
Exclusion Criteria:
Part A:
Part B:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22622425 | Derived | Papp KA, Reid C, Foley P, Sinclair R, Salinger DH, Williams G, Dong H, Krueger JG, Russell CB, Martin DA. Anti-IL-17 receptor antibody AMG 827 leads to rapid clinical response in subjects with moderate to severe psoriasis: results from a phase I, randomized, placebo-controlled trial. J Invest Dermatol. 2012 Oct;132(10):2466-2469. doi: 10.1038/jid.2012.163. Epub 2012 May 24. No abstract available. |
| 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 | Placebo Part B | Single SC or IV dose of matching placebo |
| FG001 | Cohort 10: 140 mg Sc Part B | 140 mg Sc PsO Population Adults with Psoriasis |
| FG002 | Cohort 11: 350 mg Sc Part B | 350 mg Sc PsO population Adults with Psoriasis |
| FG003 | Cohort 9: 700 mg IV Part B | 700 mg IV PsO population Adults with Psoriasis |
| FG004 | Placebo Part A | Single SC or IV dose of matching placebo |
| FG005 | Cohort 1: 7mg SC Part A | 7mg SC PsO population |
| FG006 | Cohort 2: 21mg SC Part A | 21mg SC PsO population |
| FG007 | Cohort 3: 21mg IV Part A | 21 mg IV PsO population |
| FG008 | Cohort 4: 70mg SC Part A | 70mg SC PsO population |
| FG009 | Cohort 5: 210mg SC Part A | 210mg SC PsO population |
| FG010 | Cohort 6: 210mg IV Part A | 210 mg IV PsO population |
| FG011 | Cohort 7: 420mg SC Part A | 420mg SC PsO Population |
| FG012 | Cohort 8: 700mg IV Part A | 700mg IV PsO population |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Part B | Single SC or IV dose of matching placebo |
| BG001 | 140 mg SC Part B | 140 mg Sc PsO Population |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43 | Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease. | This PASI outcome measure data refers only to Part B subjects with moderate to severe plaque psoriasis. | Posted | Mean | Standard Deviation | percentage improvement | Through day 43 |
|
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 | Placebo Part B | Single SC or IV dose of matching placebo |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Irritation | Eye disorders | Non-systematic Assessment |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 350 mg SC | Drug | single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). |
|
| Placebo | Drug | single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). |
|
| 140 mg SC | Drug | single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). |
|
| BG002 |
| 350 mg SC Part B |
350 mg Sc PsO population |
| BG003 | 700 mg IV Part B | 700 mg IV PsO population |
| BG004 | Placebo Part A | Single SC or IV dose of matching placebo |
| BG005 | 7mg SC Part A | 7mg SC PsO population |
| BG006 | 21mg SC Part A | 21mg SC PsO population |
| BG007 | 21mg IV Part A | 21mg IV PsO population |
| BG008 | 70mg SC Part A | 70mg SC Pso population |
| BG009 | 210mg SC Part A | 210mg SC PsO population |
| BG010 | 210mg IV Part A | 210mg IV PsO population |
| BG011 | 420mg SC Part A | 420mg SC PsO population |
| BG012 | 700mg IV Part A | 700mg IV PsO population |
| BG013 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| 350 mg Sc |
350 mg Sc PsO population |
| OG003 | 700 mg IV | 700 mg IV PsO population |
|
|
| Primary | Part B: All Treatment Adverse Events Reported for Safety Evaluation | This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period. | Posted | Number | participants with events | 85 days |
|
|
|
| Primary | Part A: All Treatment Adverse Events Reported for Safety Evaluation | This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period. | Posted | Number | participants with events | Cohort 1-4 43 days, Cohort 5-8 64 days |
|
|
|
| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | Cohort 10: 140 mg Sc Part B | 140 mg Sc PsO Population | 0 | 4 | 4 | 4 |
| EG002 | Cohort 11: 350 mg Sc Part B | 350 mg Sc PsO population | 0 | 8 | 8 | 8 |
| EG003 | Cohort 9: 700 mg IV Part B | 700 mg IV PsO population | 0 | 8 | 8 | 8 |
| EG004 | Placebo Part A | Single SC or IV dose of matching placebo | 0 | 14 | 14 | 14 |
| EG005 | Cohort 1: 7mg SC Part A | 7mg SC PsO population | 0 | 6 | 6 | 6 |
| EG006 | Cohort 2: 21mg SC Part A | 21mg SC PsO population ... | 0 | 6 | 6 | 6 |
| EG007 | Cohort 3: 21mg IV Part A | 21 mg IV PsO population ... | 0 | 3 | 3 | 3 |
| EG008 | Cohort 4: 70mg SC Part A | 70mg SC PsO population ... | 0 | 6 | 6 | 6 |
| EG009 | Cohort 5: 210mg SC Part A | 210mg SC PsO population ... | 0 | 6 | 6 | 6 |
| EG010 | Cohort 6: 210mg IV Part A | 210 mg IV PsO population ... | 0 | 4 | 4 | 4 |
| EG011 | Cohort 7: 420mg SC Part A | 420mg SC PsO Population ... | 0 | 6 | 5 | 6 |
| EG012 | Cohort 8: 700mg IV Part A | 700mg IV PsO population ... | 0 | 6 | 6 | 6 |
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrooesphageal Disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Influenza Like Illness | General disorders | Non-systematic Assessment |
|
| Injection Site Inflammation | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | Non-systematic Assessment |
|
| Gingival Infection | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| oral herpes | Infections and infestations | Non-systematic Assessment |
|
| Post Procedural Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Injection Site Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| External ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Eye pruritis | Eye disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrheoa | Gastrointestinal disorders | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Catheter Site Haemorrhage | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Injection site pain | General disorders | Non-systematic Assessment |
|
| Injection site pruritis | General disorders | Non-systematic Assessment |
|
| Injection site reaction | General disorders | Non-systematic Assessment |
|
| Malaise | General disorders | Non-systematic Assessment |
|
| Vessel Puncture Site Haematoma | General disorders | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Arthropod bite | Investigations | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Electrocardiogram Qt Corrected Interval Prolonged | Investigations | Non-systematic Assessment |
|
| Electrocardiogram Qt Prolonged | Investigations | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dandruff | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Seborrhoeic Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | Non-systematic Assessment |
|
| Post procedural infection | Infections and infestations | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Vaginal Haemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pharyngeal Erythema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Koebner Phenomenon | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | Non-systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | Non-systematic Assessment |
|
Not provided