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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007844-33 | EudraCT Number |
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This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled, moderate-to-severe, persistent asthma.
Study MI-CP199, a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm, multicenter study will evaluate the effect of 3 SC treatment regimens of CAT-354 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
| CAT-354 150 mg | Experimental | CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
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| CAT-354 300 mg | Experimental | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
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| CAT-354 600 mg | Experimental | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 | Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. | Day 1 and 92 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Observed Asthma Control | Time to first asthma control was defined as the number of days from Study Day 1 to the post-baseline ACQ score measurement time point when greater than or equal to (>=) 0.5 reduction from baseline in mean ACQ score was first observed. Time to first asthma control was analyzed from Day 1 through Day 92 and up to entire study duration through Day 169. The ACQ score is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MedImmune LLC | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Burgas | 8000 | Bulgaria | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22743678 | Background | Piper E, Brightling C, Niven R, Oh C, Faggioni R, Poon K, She D, Kell C, May RD, Geba GP, Molfino NA. A phase II placebo-controlled study of tralokinumab in moderate-to-severe asthma. Eur Respir J. 2013 Feb;41(2):330-8. doi: 10.1183/09031936.00223411. Epub 2012 Jun 27. | |
| 28758192 | Derived | Baverel PG, White N, Vicini P, Karlsson MO, Agoram B. Dose-Exposure-Response Relationship of the Investigational Anti-Interleukin-13 Monoclonal Antibody Tralokinumab in Patients With Severe, Uncontrolled Asthma. Clin Pharmacol Ther. 2018 May;103(5):826-835. doi: 10.1002/cpt.803. Epub 2017 Sep 28. |
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A total of 357 participants were screened in this study, out of which 194 participants me the eligibility criteria and were enrolled and randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| FG001 | CAT-354 150 mg | CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| CAT-354 150 mg | Biological | CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
| CAT-354 300 mg | Biological | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
| CAT-354 600 mg | Biological | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
| Day 1 to Day 92 and Day 169 |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Forced Expiratory Volume in 1 Second (FEV1) is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting/standing (kept consistent at each visit) position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 3 but no more than 8) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis. Data collected on Day 1 prior to dosing was considered as baseline. | Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 |
| Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean of the data was collected over 1 week prior to dosing on Day 1 was considered as baseline. Mean PEF values for each week were used to calculate the change from baseline values starting from Day 2 to 169. | Day -7 to 1 (predose), Day 2 to 169 |
| Number of Puffs of Rescue Beta-2 Agonist Per Week | Number of Puffs of Rescue Beta-2 Agonist Per Week Rescue beta-2 agonist use (total number of puffs for the preceding week) was collected daily in the morning by the participants in the daily diary provided to them. Average values for each week were reported starting from Day -7 to Day 169. | Day -7 to 169 |
| Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). | Day 1, 29, 57, 92, 127 and 169 |
| Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data collected on Day 1 prior to dosing was considered as baseline | Day 1, 29, 57, 92, 127 and 169 |
| Patient Global Impression of Change (PGIC) | Patient Global Impression of Change (PGIC): participant rated instrument to measure participant's change in overall status compared to baseline on a 7-point scale; range from 1 (very much worse) to 7 (very much better). | Day 92 and 169 |
| Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | Percentage of participants with mean Asthma Control Questionnaire (ACQ) score less than or equal to (<=) 0.75 or mean ACQ score greater than (>) 0.75 and less than (<) 1.5 were analyzed. The ACQ is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Mean ACQ scores of less than or equal to (<=) 0.75 indicated well-controlled asthma, mean ACQ scores greater than (>) 0.75 but less than (<) 1.5 indicated partly controlled asthma. | Day 92 and 169 |
| Serum Concentration for CAT-354 | Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169 |
| Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit | Day 1, 92 and 169 |
| Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit | Day 1, 92 and 169 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state. | Day 1 to 169 |
| Percentage of Participants With at Least 1 Moderate or Severe Exacerbation | Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >= 20 percent (%) in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation severity was classified as: 1) Moderate-worsening symptoms that required systemic corticosteroids. 2) Severe-worsening symptoms that required systemic corticosteroids and hospital admission. | Day 92 and 169 |
| Moderate or Severe Asthma Exacerbations Per Person Per Annum | Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation rate, calculated as total asthma exacerbations per person per annum, was assessed based on asthma exacerbation data up to Day 92 and 169 (Rate = mean asthma exacerbations for all participants/X days*365 days, where X = 92 or 169). | Day 1 to Day 92 and Day 169 |
| Time to First Moderate or Severe Asthma Exacerbation | Time to first moderate or severe asthma exacerbation was defined as time to first observed progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. | Day 1 to Day 92 and Day 169 |
| Plovdiv |
| 4000 |
| Bulgaria |
| Research Site | Rousse | 7000 | Bulgaria |
| Research Site | Rousse | Bulgaria |
| Research Site | Sofia | 1000 | Bulgaria |
| Research Site | Sofia | 1431 | Bulgaria |
| Research Site | Sofia | 1606 | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Sofia III | Bulgaria |
| Research Site | Sofia II | Bulgaria |
| Research Site | Stara Zagora | 6000 | Bulgaria |
| Research Site | Stara Zagora | Bulgaria |
| Research Site | Varna | 9000 | Bulgaria |
| Research Site | Varna | Bulgaria |
| Research Site | Berlin | 10117 | Germany |
| Research Site | Berlin | 14057 | Germany |
| Research Site | Berlin | Germany |
| Research Site | Frankfurt am Main | 60389 | Germany |
| Research Site | Frankfurt am Main | Germany |
| Research Site | Landsberg A. Lech | Germany |
| Research Site | Lich | 86899 | Germany |
| Research Site | Mainz | 55131 | Germany |
| Research Site | Mainz | Germany |
| Research Site | Bielsko-Biala | Poland |
| Research Site | Gdansk | 80-211 | Poland |
| Research Site | Lodz | 90-153 | Poland |
| Research Site | Lodz | Poland |
| Research Site | Pikary Slaskie | Poland |
| Research Site | Skalskie | 41-940 | Poland |
| Research Site | Warsaw | 00-909 | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Warsazawa | 01-138 | Poland |
| Research Site | Warszawa II | Poland |
| Research Site | Wroclaw | 54-239 | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Zabrze | 41-800 | Poland |
| Research Site | Zabrze | Poland |
| Research Site | Zabrze II | Poland |
| Research Site | Arad | 310011 | Romania |
| Research Site | Arad | 310085 | Romania |
| Research Site | Arad | Romania |
| Research Site | Bucharest | 030303 | Romania |
| Research Site | Bucharest | 050159 | Romania |
| Research Site | Bucharest | 050554 | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Cluj-Napoca | 400371 | Romania |
| Research Site | Cluj-Napoca | Romania |
| Research Site | Deva | 050554 | Romania |
| Research Site | Deva | Romania |
| Research Site | Timisoara Timis | 300310 | Romania |
| Research Site | Timișoara | Romania |
| Research Site | Wythenshawe | Manchester | M23 9QZ | United Kingdom |
| Research Site | Cambridge | CB23 2TN | United Kingdom |
| Research Site | Cambridge | United Kingdom |
| Research Site | Leicester | LE3 9QP | United Kingdom |
| Research Site | Leicester | United Kingdom |
| Research Site | Manchester | United Kingdom |
| 25614165 | Derived | Wilkes DS, Chew T, Flaherty KR, Frye S, Gibson KF, Kaminski N, Klemsz MJ, Lange W, Noth I, Rothhaar K. Oral immunotherapy with type V collagen in idiopathic pulmonary fibrosis. Eur Respir J. 2015 May;45(5):1393-402. doi: 10.1183/09031936.00105314. Epub 2015 Jan 22. |
| FG002 | CAT-354 300 mg | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| FG003 | CAT-354 600 mg | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) population included all participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| BG001 | CAT-354 150 mg | CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| BG002 | CAT-354 300 mg | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| BG003 | CAT-354 600 mg | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| BG004 | 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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| 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 | Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 | Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. | Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued prior to receiving 4 doses due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Day 1 and 92 |
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| Secondary | Time to First Observed Asthma Control | Time to first asthma control was defined as the number of days from Study Day 1 to the post-baseline ACQ score measurement time point when greater than or equal to (>=) 0.5 reduction from baseline in mean ACQ score was first observed. Time to first asthma control was analyzed from Day 1 through Day 92 and up to entire study duration through Day 169. The ACQ score is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). | Evaluable population = all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Since, >50% participants for each arm achieved improvement through Day 92; the median time-to-first observed achievement is identical for data through Day 92 and Day 169. | Posted | Median | 95% Confidence Interval | days | Day 1 to Day 92 and Day 169 |
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| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Forced Expiratory Volume in 1 Second (FEV1) is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting/standing (kept consistent at each visit) position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 3 but no more than 8) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis. Data collected on Day 1 prior to dosing was considered as baseline. | Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively. | Posted | Mean | Standard Deviation | liters | Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 |
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| Secondary | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean of the data was collected over 1 week prior to dosing on Day 1 was considered as baseline. Mean PEF values for each week were used to calculate the change from baseline values starting from Day 2 to 169. | Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively. | Posted | Mean | Standard Deviation | liters/minute | Day -7 to 1 (predose), Day 2 to 169 |
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| Secondary | Number of Puffs of Rescue Beta-2 Agonist Per Week | Number of Puffs of Rescue Beta-2 Agonist Per Week Rescue beta-2 agonist use (total number of puffs for the preceding week) was collected daily in the morning by the participants in the daily diary provided to them. Average values for each week were reported starting from Day -7 to Day 169. | Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively. | Posted | Mean | Standard Deviation | puffs per week | Day -7 to 169 |
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| Secondary | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). | Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Day 1, 29, 57, 92, 127 and 169 |
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| Secondary | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data collected on Day 1 prior to dosing was considered as baseline | Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Day 1, 29, 57, 92, 127 and 169 |
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| Secondary | Patient Global Impression of Change (PGIC) | Patient Global Impression of Change (PGIC): participant rated instrument to measure participant's change in overall status compared to baseline on a 7-point scale; range from 1 (very much worse) to 7 (very much better). | Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Day 92 and 169 |
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| Secondary | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | Percentage of participants with mean Asthma Control Questionnaire (ACQ) score less than or equal to (<=) 0.75 or mean ACQ score greater than (>) 0.75 and less than (<) 1.5 were analyzed. The ACQ is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Mean ACQ scores of less than or equal to (<=) 0.75 indicated well-controlled asthma, mean ACQ scores greater than (>) 0.75 but less than (<) 1.5 indicated partly controlled asthma. | Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. | Posted | Number | percentage of participants | Day 92 and 169 |
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| Secondary | Serum Concentration for CAT-354 | Pharmacokinetic (PK) population included participants who received CAT-354 and had a sufficient number of serum concentration measurements for computing PK parameters. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169 |
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| Secondary | Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit | Safety population included all participants who received any dose of the investigational product. Here, 'N'(number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | participants | Day 1, 92 and 169 |
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| Secondary | Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit | Safety population included all participants who received any dose of the investigational product. Here, 'N'(number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of participants | Day 1, 92 and 169 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state. | Safety population included all participants who received any dose of the investigational product. | Posted | Number | participants | Day 1 to 169 |
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| Secondary | Percentage of Participants With at Least 1 Moderate or Severe Exacerbation | Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >= 20 percent (%) in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation severity was classified as: 1) Moderate-worsening symptoms that required systemic corticosteroids. 2) Severe-worsening symptoms that required systemic corticosteroids and hospital admission. | Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. No separate analyses were performed for moderate and severe exacerbations since only 1 participant had a severe exacerbation. | Posted | Number | Percentage of Participants | Day 92 and 169 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Moderate or Severe Asthma Exacerbations Per Person Per Annum | Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation rate, calculated as total asthma exacerbations per person per annum, was assessed based on asthma exacerbation data up to Day 92 and 169 (Rate = mean asthma exacerbations for all participants/X days*365 days, where X = 92 or 169). | Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. | Posted | Mean | Standard Error | asthma exacerbations/person/annum | Day 1 to Day 92 and Day 169 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Moderate or Severe Asthma Exacerbation | Time to first moderate or severe asthma exacerbation was defined as time to first observed progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. | Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. | Posted | Mean | Standard Error | days | Day 1 to Day 92 and Day 169 |
|
Day 1 to 169
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 | Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. | 3 | 47 | 17 | 47 | ||
| EG001 | CAT-354 150 mg | CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. | 2 | 47 | 19 | 47 | ||
| EG002 | CAT-354 300 mg | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. | 0 | 51 | 25 | 51 | ||
| EG003 | CAT-354 600 mg | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. | 1 | 48 | 25 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Post cholecystectomy syndrome | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Somatoform disorder | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Monocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Monocytosis | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Infusion site induration | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| H1n1 influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pharyngitis bacterial | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Blood bilirubin | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Blood chloride increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Reticulocyte count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Crystalluria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nitrituria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract inflammation | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Menopausal disorder | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Labile hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meena Jain, MB BChir/Associate Medical Director | MedImmune, LLC | 301-398-0000 | jainm@medimmune.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung 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
| Male |
|
| Change at Day 92 (n= 46, 46, 51, 47) |
|
Change at Day 92: p-value was based on ANOVA. |
| Superiority or Other |
| ANOVA | 0.224 | Change at Day 92: p-value was based on ANOVA. | Superiority or Other |
| OG002 | CAT-354 300 mg | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| OG003 | CAT-354 600 mg | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
|
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| OG002 | CAT-354 300 mg | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| OG003 | CAT-354 600 mg | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
| OG003 | CAT-354 600 mg | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
| OG003 |
| CAT-354 600 mg |
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
| OG002 | CAT-354 300 mg | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| OG003 | CAT-354 600 mg | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
| OG002 | CAT-354 300 mg | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| OG003 | CAT-354 600 mg | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
| OG002 | CAT-354 300 mg | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| OG003 | CAT-354 600 mg | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | CAT-354 600 mg | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
| CAT-354 300 mg |
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| OG003 | CAT-354 600 mg | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
|
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| OG003 | CAT-354 600 mg | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
|
| OG003 |
| CAT-354 600 mg |
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
|
|
|