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A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a history of asthma exacerbations.
Approximately 1140 subjects will be randomized globally. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tralokinumab Dose Regimen 1 | Experimental | Tralokinumab subcutaneous injection |
|
| Placebo Dose Regimen 1 | Placebo Comparator | Placebo subcutaneous injection |
|
| Tralokinumab Dose Regimen 2 | Experimental | Tralokinumab subcutaneous injection |
|
| Placebo Dose Regimen 2 | Placebo Comparator | Placebo subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tralokinumab | Biological | Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualised Asthma Exacerbation Rate (AAER) up to Week 52 | Asthma exacerbation was defined as a worsening of asthma that led to any of the following:
AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks). AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses. | Baseline (Week 0) up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) | Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reynold A Panettieri, M.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35209 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31315668 | Derived | Gottlow M, Svensson DJ, Lipkovich I, Huhn M, Bowen K, Wessman P, Colice G. Application of structured statistical analyses to identify a biomarker predictive of enhanced tralokinumab efficacy in phase III clinical trials for severe, uncontrolled asthma. BMC Pulm Med. 2019 Jul 17;19(1):129. doi: 10.1186/s12890-019-0889-4. | |
| 30649752 |
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This is commercially sensitive information.
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2248 patients signed informed consent, 1669 entered screening/run-in period, 1207 patients were randomised to receive treatment with tralokinumab 300 milligrams (mg), or placebo, every 2 weeks (Q2W) or every 4 weeks (Q4W). Of the 1207 patients randomised, 1202 received investigational product (IP).
First patient enrolled: 13 Jun 2014; Week 52 cut-off: 28 Feb 2017; Last Patient Last Visit Week 72: 18 Jul 2017. Study performed at 254 sites in 14 countries.
Patients were maintained on currently prescribed inhaled corticosteroid long-acting β2-agonist therapy + any additional maintenance asthma controller medications throughout the study period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tralo 300 mg Q2W | Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72. |
| FG001 | Tralo 300 mg Q4W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomised Through Start Treatment |
|
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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 | Feb 26, 2018 | Jun 5, 2018 |
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| Placebo | Other | Subcutaneous injection |
|
| Baseline (Week 0) and Week 52 |
| Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means) | Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented. | Baseline (Week 0) and Week 52 |
| Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score | The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented. | Baseline (Week 0) and Week 52 |
| Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score | The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score >1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented. | Baseline (Week 0) and Week 52 |
| AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52 | The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form). AAER = Number of Exacerbations*365.25 / (Follow-up date - Date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks). | Baseline (Week 0) up to Week 52 |
| Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52 | The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented. | Baseline (Week 0) and Week 52 |
| Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means) | Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented. | Baseline (Week 0) and Week 52 |
| Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52 | Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening. | Baseline (Week 0) and Week 52 |
| Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage]) | The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented. | Baseline (Week 0) and Week 52 |
| Number of Patients With ≥1 Asthma Exacerbation up to Week 52 | The number of patients with ≥1 asthma exacerbation up to Week 52 is presented. | Baseline (Week 0) up to Week 52 |
| Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52 | The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days. The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity. Work Productivity Loss = {Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]}*100 (Absenteeism = Q2/(Q2+Q4)*100; Presenteeism = (Q5/10)*100). Class Productivity Loss = {Q7/(Q7+Q8) + [(1-Q7/(Q7+Q8))x(Q9/10)]}*100 (Absenteeism = Q7/ (Q7+Q8)*100; Presenteeism = (Q9/10)*100). Note: QX refers to response to question number X on WPAI+CIQ questionnaire. | At Week 52 |
| WPAI+CIQ: Activity Impairment at Week 52 | The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days. The WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment. Activity impairment = (Q10/10)*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire. | At Week 52 |
| Asthma-related Healthcare Encounters by Type up to Week 52 | Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories:
| Baseline (Week 0) up to Week 52 |
| Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations | Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of days spent in hospital was calculated across all patients for the following healthcare encounter category: • Hospitalisations (hospitalisations, intensive care and/or general care). | Baseline (Week 0) up to Week 52 |
| Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry | Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of assessments was calculated across all patients for the following healthcare encounter category: • Spirometry. | Baseline (Week 0) up to Week 52 |
| Serum Trough Concentration (Ctrough) of Tralokinumab During the Study Period up to Week 72 | To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72. | Blood samples were collected pre-dose at Baseline (Week 0), and at Week 4, Week 8, Week 26, Week 52 and Week 72 (follow-up) |
| Number of Patients Positive for Anti-drug Antibodies (ADAs) | ADA assessments performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for neutralising antibodies (nAb). ADA prevalence defined as proportion of study population with drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) defined as sum of treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive defined as having ≥1 post-baseline ADA positive assessment and not fulfilling conditions of persistently positive. Treatment-boosted ADA defined as baseline positive ADA titer boosted to a 4-fold or higher level following drug administration. In some category titles 'positive' is denoted by 'pos'. | Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up) |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Research Site | Arcadia | California | 91007 | United States |
| Research Site | Los Angeles | California | 90036 | United States |
| Research Site | Los Angeles | California | 90048 | United States |
| Research Site | Newport Beach | California | 92663 | United States |
| Research Site | Poway | California | 92064 | United States |
| Research Site | San Jose | California | 95117 | United States |
| Research Site | Tustin | California | 92780 | United States |
| Research Site | Wildomar | California | 92595 | United States |
| Research Site | Colorado Springs | Colorado | 80907 | United States |
| Research Site | Denver | Colorado | 80206 | United States |
| Research Site | Denver | Colorado | 80246 | United States |
| Research Site | New Haven | Connecticut | 06519 | United States |
| Research Site | Clearwater | Florida | 33765 | United States |
| Research Site | Coral Gables | Florida | 33134 | United States |
| Research Site | Cutler Bay | Florida | 33189 | United States |
| Research Site | Fort Lauderdale | Florida | 33308 | United States |
| Research Site | Hialeah | Florida | 33012 | United States |
| Research Site | Hialeah | Florida | 33013 | United States |
| Research Site | Homestead | Florida | 33030 | United States |
| Research Site | Homestead | Florida | 33130 | United States |
| Research Site | Jacksonville | Florida | 32277 | United States |
| Research Site | Kissimmee | Florida | 34741 | United States |
| Research Site | Miami | Florida | 33125 | United States |
| Research Site | Miami | Florida | 33126 | United States |
| Research Site | Miami | Florida | 33134 | United States |
| Research Site | Miami | Florida | 33135 | United States |
| Research Site | Miami | Florida | 33144 | United States |
| Research Site | Miami | Florida | 33145 | United States |
| Research Site | Miami | Florida | 33155 | United States |
| Research Site | Miami | Florida | 33166 | United States |
| Research Site | Miami | Florida | 33173 | United States |
| Research Site | Miami | Florida | 33174 | United States |
| Research Site | Miami | Florida | 33175 | United States |
| Research Site | Miami | Florida | 33176 | United States |
| Research Site | Ormond Beach | Florida | 32174 | United States |
| Research Site | Pembroke Pines | Florida | 33029 | United States |
| Research Site | Winter Park | Florida | 32789 | United States |
| Research Site | Albany | Georgia | 31707 | United States |
| Research Site | Atlanta | Georgia | 30331 | United States |
| Research Site | Lawrenceville | Georgia | 30046 | United States |
| Research Site | Meridian | Idaho | 83642 | United States |
| Research Site | Twin Falls | Idaho | 83301 | United States |
| Research Site | Fort Wayne | Indiana | 46804 | United States |
| Research Site | South Bend | Indiana | 46617 | United States |
| Research Site | Bowling Green | Kentucky | 42101 | United States |
| Research Site | Bangor | Maine | 04401 | United States |
| Research Site | Brockton | Massachusetts | 2301 | United States |
| Research Site | Ann Arbor | Michigan | 48106 | United States |
| Research Site | Farmington Hills | Michigan | 48334 | United States |
| Research Site | Flint | Michigan | 48504 | United States |
| Research Site | Ypsilanti | Michigan | 48197 | United States |
| Research Site | Chesterfield | Missouri | 63017 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | St Louis | Missouri | 63143 | United States |
| Research Site | Missoula | Montana | 59808 | United States |
| Research Site | Las Vegas | Nevada | 89123 | United States |
| Research Site | Union | New Jersey | 07083 | United States |
| Research Site | Brooklyn | New York | 11229 | United States |
| Research Site | Asheville | North Carolina | 28801 | United States |
| Research Site | Charlotte | North Carolina | 28277 | United States |
| Research Site | Cornelius | North Carolina | 28031 | United States |
| Research Site | Hickory | North Carolina | 28078 | United States |
| Research Site | Shelby | North Carolina | 28150 | United States |
| Research Site | Winston-Salem | North Carolina | 27104 | United States |
| Research Site | Columbus | Ohio | 43235 | United States |
| Research Site | Middleburg Heights | Ohio | 44130 | United States |
| Research Site | Toledo | Ohio | 43617 | United States |
| Research Site | Oklahoma City | Oklahoma | 73112 | United States |
| Research Site | Oklahoma City | Oklahoma | 73131 | United States |
| Research Site | Monroeville | Pennsylvania | 15146 | United States |
| Research Site | Philadelphia | Pennsylvania | 19115 | United States |
| Research Site | Scottdale | Pennsylvania | 15683 | United States |
| Research Site | Uniontown | Pennsylvania | 15683 | United States |
| Research Site | Johnston | Rhode Island | 02919 | United States |
| Research Site | Providence | Rhode Island | 02908 | United States |
| Research Site | Warwick | Rhode Island | 02886 | United States |
| Research Site | Anderson | South Carolina | 29621 | United States |
| Research Site | Greenville | South Carolina | 29607 | United States |
| Research Site | Myrtle Beach | South Carolina | 29588 | United States |
| Research Site | Spartanburg | South Carolina | 29303 | United States |
| Research Site | Boerne | Texas | 78006 | United States |
| Research Site | Corsicana | Texas | 75110 | United States |
| Research Site | Dallas | Texas | 75225 | United States |
| Research Site | Fort Worth | Texas | 76104 | United States |
| Research Site | Fort Worth | Texas | 76109 | United States |
| Research Site | Houston | Texas | 77043 | United States |
| Research Site | Houston | Texas | 77084 | United States |
| Research Site | Houston | Texas | 77099 | United States |
| Research Site | Lampasas | Texas | 76550 | United States |
| Research Site | McKinney | Texas | 75069 | United States |
| Research Site | Plano | Texas | 75093 | United States |
| Research Site | San Antonio | Texas | 78218 | United States |
| Research Site | San Antonio | Texas | 78258 | United States |
| Research Site | Murray | Utah | 84107 | United States |
| Research Site | Provo | Utah | 84604 | United States |
| Research Site | Salt Lake City | Utah | 84102 | United States |
| Research Site | South Burlington | Vermont | 05403 | United States |
| Research Site | Arlington | Virginia | 22203 | United States |
| Research Site | Richmond | Virginia | 23225 | United States |
| Research Site | Richland | Washington | 99352 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Research Site | Buenos Aires | C1414AIF | Argentina |
| Research Site | CABA | C1425BEN | Argentina |
| Research Site | Cap. Fed | 1280 | Argentina |
| Research Site | Ciudad Autonomade Buenos Aires | 1426 | Argentina |
| Research Site | Concepción del Uruguay | 3260 | Argentina |
| Research Site | Córdoba | X5003DCE | Argentina |
| Research Site | Mendoza | 5500 | Argentina |
| Research Site | Mendoza | M5500GIP | Argentina |
| Research Site | Quilmes | B1878FNR | Argentina |
| Research Site | Rosario | S2000DEJ | Argentina |
| Research Site | San Miguel de Tucumán | 4000 | Argentina |
| Research Site | Brussels (Anderlecht) | 1070 | Belgium |
| Research Site | Erpent | 5101 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Dupnitsa | 2600 | Bulgaria |
| Research Site | Kozloduy | 3320 | Bulgaria |
| Research Site | Pazardzhik | 4400 | Bulgaria |
| Research Site | Pernik | 2307 | Bulgaria |
| Research Site | Rousse | 7002 | Bulgaria |
| Research Site | Sliven | 8800 | Bulgaria |
| Research Site | Sofia | 1202 | Bulgaria |
| Research Site | Sofia | 1407 | Bulgaria |
| Research Site | Sofia | 1618 | Bulgaria |
| Research Site | Stara Zagora | 6000 | Bulgaria |
| Research Site | Varna | 9000 | Bulgaria |
| Research Site | Veliko Tarnovo | 5000 | Bulgaria |
| Research Site | Vratsa | 3000 | Bulgaria |
| Research Site | Yambol | 8600 | Bulgaria |
| Research Site | Armenia | 630004 | Colombia |
| Research Site | Bogotá | 110311 | Colombia |
| Research Site | Bogotá | Colombia |
| Research Site | Cali | 76001000 | Colombia |
| Research Site | Aschaffenburg | 63739 | Germany |
| Research Site | Augsburg | 86150 | Germany |
| Research Site | Bad Lippspringe | 33175 | Germany |
| Research Site | Geesthacht | 21502 | Germany |
| Research Site | Herford | 32049 | Germany |
| Research Site | Landsberg | 86899 | Germany |
| Research Site | Leipzig | 04357 | Germany |
| Research Site | München-Pasing | 81241 | Germany |
| Research Site | Reinfeld | 23858 | Germany |
| Research Site | Rodgau-Dudenhofen | 63110 | Germany |
| Research Site | Warendorf | 48231 | Germany |
| Research Site | Balassagyarmat | 2660 | Hungary |
| Research Site | Edelény | 3780 | Hungary |
| Research Site | Farkasgyepü | 8582 | Hungary |
| Research Site | Komárom | 2900 | Hungary |
| Research Site | Létavértes | 4281 | Hungary |
| Research Site | Miskolc | 3529 | Hungary |
| Research Site | Pécs | 7626 | Hungary |
| Research Site | Pécs | 7635 | Hungary |
| Research Site | Százhalombatta | 2440 | Hungary |
| Research Site | Cusco | CUSCO 01 | Peru |
| Research Site | Lima | 41 | Peru |
| Research Site | Lima | L27 | Peru |
| Research Site | Lima | LIMA 1 | Peru |
| Research Site | Lima | LIMA 21 | Peru |
| Research Site | Lima | LIMA 29 | Peru |
| Research Site | Lima | LIMA 32 | Peru |
| Research Site | Lima | LIMA 33 | Peru |
| Research Site | Lima | LIMA 41 | Peru |
| Research Site | Będzin | 42-500 | Poland |
| Research Site | Bydgoszcz | 85-079 | Poland |
| Research Site | Chorzów | 41-500 | Poland |
| Research Site | Gdansk | 80-405 | Poland |
| Research Site | Gdansk | 80-546 | Poland |
| Research Site | Grudziądz | 86-300 | Poland |
| Research Site | Kielce | 25-734 | Poland |
| Research Site | Krakow | 31-209 | Poland |
| Research Site | Lodz | 90-153 | Poland |
| Research Site | Lubin | 59-300 | Poland |
| Research Site | Lublin | 20-363 | Poland |
| Research Site | Lublin | 20-468 | Poland |
| Research Site | Mrozy | 05-320 | Poland |
| Research Site | Olsztyn | 10-357 | Poland |
| Research Site | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Research Site | Ostrów Wielkopolski | 63-400 | Poland |
| Research Site | Oświęcim | 32-600 | Poland |
| Research Site | Puławy | 24-100 | Poland |
| Research Site | Racibórz | 47-400 | Poland |
| Research Site | Skierniewice | 96-100 | Poland |
| Research Site | Staszów | 28-200 | Poland |
| Research Site | Warsaw | 01-138 | Poland |
| Research Site | Wieluń | 98-300 | Poland |
| Research Site | Wołomin | 05-200 | Poland |
| Research Site | Wroclaw | 50-220 | Poland |
| Research Site | Wroclaw | 51-162 | Poland |
| Research Site | Zamość | 22-400 | Poland |
| Research Site | Zgierz | 95-100 | Poland |
| Research Site | Humenné | 066 01 | Slovakia |
| Research Site | Kežmarok | 060 01 | Slovakia |
| Research Site | Prešov | 08001 | Slovakia |
| Research Site | Sabinov | Slovakia |
| Research Site | Topoľčany | 955 01 | Slovakia |
| Research Site | Bucheon-si | 14584 | South Korea |
| Research Site | Cheongju-si | 362-804 | South Korea |
| Research Site | Daegu | 42415 | South Korea |
| Research Site | Incheon | 21431 | South Korea |
| Research Site | Incheon | 405-760 | South Korea |
| Research Site | Jeju City | 63241 | South Korea |
| Research Site | Seoul | 02559 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06591 | South Korea |
| Research Site | Seoul | 08308 | South Korea |
| Research Site | Seoul | 135-710 | South Korea |
| Research Site | Seoul | 150-713 | South Korea |
| Research Site | Suwon | 16499 | South Korea |
| Research Site | Alicante | 03004 | Spain |
| Research Site | Badalona | 08916 | Spain |
| Research Site | Hospitalet de Llobregat(Barcel | 08907 | Spain |
| Research Site | Santander | 39008 | Spain |
| Research Site | Valencia | 46015 | Spain |
| Research Site | Changhua | 500 | Taiwan |
| Research Site | Kaohsiung City | Taiwan |
| Research Site | New Taipei City | 22056 | Taiwan |
| Research Site | Taichung | 404 | Taiwan |
| Research Site | Taipei | 100 | Taiwan |
| Research Site | Taipei | 235 | Taiwan |
| Research Site | Yilan | 260 | Taiwan |
| Research Site | Chernivtsi | 58000 | Ukraine |
| Research Site | Chernivtsi | 58001 | Ukraine |
| Research Site | Ivano-Frankivsk | 76012 | Ukraine |
| Research Site | Kharkiv | 61002 | Ukraine |
| Research Site | Kharkiv | 61058 | Ukraine |
| Research Site | Kharkiv | 61093 | Ukraine |
| Research Site | Kyiv | 02125 | Ukraine |
| Research Site | Lutsk | 43000 | Ukraine |
| Research Site | Lviv | 79066 | Ukraine |
| Research Site | Odesa | 65025 | Ukraine |
| Research Site | Vinnytsia | 21001 | Ukraine |
| Research Site | Zaporizhzhya | 69063 | Ukraine |
| Research Site | Zaporizhzhya | 69065 | Ukraine |
| Research Site | Can Tho | 900000 | Vietnam |
| Research Site | Hanoi | 100000 | Vietnam |
| Research Site | Hà Nội | 100000 | Vietnam |
| Research Site | Ho Chi Minh City | 700000 | Vietnam |
| Research Site | Hochiminh | Vietnam |
| Carlsson M, Braddock M, Li Y, Wang J, Xu W, White N, Megally A, Hunter G, Colice G. Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma. Drug Saf. 2019 Jun;42(6):769-784. doi: 10.1007/s40264-018-00788-w. |
| 29792288 | Derived | Panettieri RA Jr, Sjobring U, Peterffy A, Wessman P, Bowen K, Piper E, Colice G, Brightling CE. Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials. Lancet Respir Med. 2018 Jul;6(7):511-525. doi: 10.1016/S2213-2600(18)30184-X. Epub 2018 May 20. |
| 29536781 | Derived | Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14. |
Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.
| FG002 | Placebo | Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Through Study Completion |
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All patients in the full analysis set (FAS) who received at least one dose of IP (tralokinumab or placebo) were included in the baseline analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tralo 300 mg Q2W | Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72. |
| BG001 | Tralo 300 mg Q4W | Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72. |
| BG002 | Placebo | Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Annualised Asthma Exacerbation Rate (AAER) up to Week 52 | Asthma exacerbation was defined as a worsening of asthma that led to any of the following:
AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks). AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. | Posted | Number | 95% Confidence Interval | Events/year | Baseline (Week 0) up to Week 52 |
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| Secondary | Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) | Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Mean | Standard Deviation | Percent change from baseline | Baseline (Week 0) and Week 52 |
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| Secondary | Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means) | Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and Week 52 |
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| Secondary | Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score | The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and Week 52 |
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| Secondary | Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score | The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score >1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and Week 52 |
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| Secondary | AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52 | The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form). AAER = Number of Exacerbations*365.25 / (Follow-up date - Date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks). | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. | Posted | Number | 95% Confidence Interval | Events/year | Baseline (Week 0) up to Week 52 |
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| Secondary | Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52 | The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and Week 52 |
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| Secondary | Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means) | Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Mean | Standard Deviation | Puffs/day | Baseline (Week 0) and Week 52 |
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| Secondary | Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52 | Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Mean | Standard Deviation | L/min | Baseline (Week 0) and Week 52 |
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| Secondary | Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage]) | The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Mean | Standard Deviation | Percentage of nights with awakenings | Baseline (Week 0) and Week 52 |
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| Secondary | Number of Patients With ≥1 Asthma Exacerbation up to Week 52 | The number of patients with ≥1 asthma exacerbation up to Week 52 is presented. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. | Posted | Count of Participants | Participants | Baseline (Week 0) up to Week 52 |
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| Secondary | Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52 | The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days. The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity. Work Productivity Loss = {Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]}*100 (Absenteeism = Q2/(Q2+Q4)*100; Presenteeism = (Q5/10)*100). Class Productivity Loss = {Q7/(Q7+Q8) + [(1-Q7/(Q7+Q8))x(Q9/10)]}*100 (Absenteeism = Q7/ (Q7+Q8)*100; Presenteeism = (Q9/10)*100). Note: QX refers to response to question number X on WPAI+CIQ questionnaire. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoint of testing were included in the analysis. | Posted | Mean | Standard Deviation | Percent productivity loss | At Week 52 |
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| Secondary | WPAI+CIQ: Activity Impairment at Week 52 | The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days. The WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment. Activity impairment = (Q10/10)*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoint of testing were included in the analysis. | Posted | Mean | Standard Deviation | Percent Impairment | At Week 52 |
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| Secondary | Asthma-related Healthcare Encounters by Type up to Week 52 | Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories:
| The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. | Posted | Number | Encounters | Baseline (Week 0) up to Week 52 |
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| Secondary | Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations | Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of days spent in hospital was calculated across all patients for the following healthcare encounter category: • Hospitalisations (hospitalisations, intensive care and/or general care). | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. | Posted | Number | Days | Baseline (Week 0) up to Week 52 |
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| Secondary | Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry | Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of assessments was calculated across all patients for the following healthcare encounter category: • Spirometry. | The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. | Posted | Number | Assessments | Baseline (Week 0) up to Week 52 |
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| Secondary | Serum Trough Concentration (Ctrough) of Tralokinumab During the Study Period up to Week 72 | To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72. | All patients in the FAS who received tralokinumab and who had PK blood samples were included in the PK analysis set. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/millilitre | Blood samples were collected pre-dose at Baseline (Week 0), and at Week 4, Week 8, Week 26, Week 52 and Week 72 (follow-up) |
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| Secondary | Number of Patients Positive for Anti-drug Antibodies (ADAs) | ADA assessments performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for neutralising antibodies (nAb). ADA prevalence defined as proportion of study population with drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) defined as sum of treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive defined as having ≥1 post-baseline ADA positive assessment and not fulfilling conditions of persistently positive. Treatment-boosted ADA defined as baseline positive ADA titer boosted to a 4-fold or higher level following drug administration. In some category titles 'positive' is denoted by 'pos'. | The ADA evaluable population included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. | Posted | Count of Participants | Participants | Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up) |
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Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.
Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.
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 | Tralo 300 mg Q2W | Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72. | 2 | 398 | 40 | 398 | 134 | 398 |
| EG001 | Tralo 300 mg Q4W | Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72. | 1 | 404 | 39 | 404 | 145 | 404 |
| EG002 | Placebo | Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. | 1 | 400 | 48 | 400 | 107 | 400 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Chronic sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Cerebrovascular disorder | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Radiculopathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Erosive duodenitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Swollen tongue | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
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| Eosinophilic granulomatosis with polyangiitis | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Diarrhoea infectious | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Vascular encephalopathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | +1 301-398-0582 | ClinicalTrialTransparency@astrazeneca.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2018 | Jun 5, 2018 | SAP_003.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C574065 | tralokinumab |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
| Death |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Comparison of AAER (rate ratio): Tralo 300 mg Q4W vs placebo. | Negative binomial | 0.4406 | Rate ratio | 0.90 | 2-Sided | 95 | 0.70 | 1.17 | Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study. | Superiority | The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo. |
| Comparison of AAER (rate reduction): Tralo 300 mg Q2W vs placebo. | Negative binominal | 0.5859 | Rate reduction | 7.01 | 2-Sided | 95 | -20.76 | 28.39 | Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study. | Superiority | The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo. |
| Comparison of AAER (rate reduction): Tralo 300 mg Q4W vs placebo. | Negative binominal | 0.4406 | Rate reduction | 9.76 | 2-Sided | 95 | -17.16 | 30.50 | Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study. | Superiority | The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo. |
|
|
|
| OG002 | Placebo | Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. |
|
|
|
| OG002 | Placebo | Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. |
|
|
|
Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.
| OG002 | Placebo | Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. |
|
|
|
|
|
|
| OG002 | Placebo | Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. |
|
|
| Placebo |
Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. |
|
|
|
Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
|
|
|
| Placebo |
Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72. |
| OG002 | Placebo | Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. |
|
|
| OG002 |
| Placebo |
Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. |
|
|
| OG002 | Placebo | Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. |
|
|
Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
|
|
|
|
| Participants |
|
|
Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72. |
| OG002 | Placebo | Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72. |
|
|