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This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.
AK001 is a monoclonal antibody which may be useful in the treatment of patients with moderate to severe nasal polyposis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 mg AK001 | Experimental | 25 mg AK001 will be administered as multiple doses |
|
| 250 mg AK001 | Experimental | 250 mg AK001 will be administered as multiple doses |
|
| Placebo | Placebo Comparator | A placebo comparator consisting of inactive excipients will be administered as multiple doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK001 low dose | Drug | 25 mg AK001 will be administered as multiple doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Polys Score (TPS) | NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Change in TPS from Baseline (prior to the first dose) to Week 12 (Day 84) was the primary outcome of the study. TPS ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps, a higher scores mean a worse outcome. | From Baseline (prior to the first dose) to Week 12 (Day 84) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claus Bachert | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator site | Chicago | Illinois | 60007 | United States | ||
| Investigator site |
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Date First Patient First Visit 04 April 2016 Date Last Patient Last Visit 05 January 2018 Date Enrollment was Terminated 31 May 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | 25 mg AK001 | 25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49. |
| FG001 | 250 mg AK001 | 250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 27, 2016 | Oct 28, 2020 |
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| AK001 high dose |
| Drug |
250 mg AK001 will be administered as multiple doses |
|
| Placebo | Drug | Placebo will be administered as multiple doses |
|
| Boston |
| Massachusetts |
| 02101 |
| United States |
| Investigator site | Pittsburgh | Pennsylvania | 15106 | United States |
| Investigator site | Houston | Texas | 77001 | United States |
| Investigator site | Charlottesville | Virginia | 22901 | United States |
| Investigator site | Ghent | Belgium |
| Investigator site | Leuven | Belgium |
| Investigator site | Düsseldorf | Germany |
| Investigator site | Münster | Germany |
| Investigator site | Amsterdam | Netherlands |
| Investigator site | Barcelona | Spain |
| Investigator site | Jerez de la Frontera | Spain |
| Investigator | Valencia | Spain |
| Investigator site | Cambridge | United Kingdom |
| Investigator site | Manchester | United Kingdom |
| FG002 | Placebo | Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 25 mg AK001 | 25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49. |
| BG001 | 250 mg AK001 | 250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49. |
| BG002 | Placebo | Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49. |
| BG003 | Total | Total of all reporting groups |
| 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 | Median | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Total Polyp Score (TPS) | Median | Full Range | units on a scale |
|
| 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 | Change in Total Polys Score (TPS) | NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Change in TPS from Baseline (prior to the first dose) to Week 12 (Day 84) was the primary outcome of the study. TPS ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps, a higher scores mean a worse outcome. | Modified Intent-to-Treat (MITT) population included all randomized subjects who have taken at least one dose of the study drug and had both a baseline and at least one post-baseline efficacy assessment. | Posted | Mean | 95% Confidence Interval | score on a scale | From Baseline (prior to the first dose) to Week 12 (Day 84) |
|
|
|
The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study.
If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
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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 | 25 mg AK001 | 25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49. | 0 | 15 | 0 | 15 | 11 | 15 |
| EG001 | 250 mg AK001 | 250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49. | 0 | 14 | 0 | 14 | 10 | 14 |
| EG002 | Placebo | Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49. | 0 | 10 | 0 | 10 | 7 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (18.0) | Systematic Assessment |
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| Heart rate increased | Investigations | MedDRA (18.0) | Systematic Assessment |
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| Weight increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasal discharge discolouration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
After 40 of the 70 patients planned were randomized in the study, enrollment was stopped as the Sponsor decided not to pursue further development of AK001. The study was not stopped for any safety concern. Early termination resulted uninterpretable data.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Henrik Rasmussen, MD, PhD, Chief Medical Officer | Allakos, Inc. | 1 6505975002 | hrasmussen@allakos.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2017 | Oct 28, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Europe |
|