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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2012-004098-26 | |||
| 2012-004098-26 | EudraCT Number |
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| Name | Class |
|---|---|
| MedImmune Ltd | INDUSTRY |
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The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection in open-label period
This is a two-part Phase 2a study compromising a 12-week, double-blind, placebo-controlled, treatment period followed by a 100-week, open label, treatment period to evaluate short-term efficacy, and the short- and long-term safety of MEDI2070 in subjects with moderate to severe, active CD who have failed or are intolerant to anti-TNFα therapy as determined by the investigator. Approximately 120 subjects will be randomized in a 1:1 ratio to initially receive a fixed IV dose of MEDI2070 or placebo on Week 0(Day1) and Week 4 (Day 29) during the 12-week, double-blind, placebo-controlled, treatment period. At the completion of the double-blind, placebo-controlled, treatment period (Week 12), subjects will have the option to enter a 100-week, open-label, treatment period where they will receive open-label MEDI2070 (SC) Q4W (Week 12 through Week 112). Subjects will be followed for safety at 3 visits over 28 weeks after their last dose of IP. Subjects will also be contacted by phone 36 weeks after their last dose of IP for safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MEDI2070 iv infusion |
|
| 2 | Placebo Comparator | placebo iv infusion |
|
| open-label | Experimental | MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI2070 | Drug | 1 iv infusion on Week 0 and Week 4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8 | A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (<)150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT)population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CDAI-70 Point Improvement at Week 8 | The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 70-point improvement is defined as a reduction from baseline in CDAI score of at least 70 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Encinitas | California | 92024 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28390867 | Background | Sands BE, Chen J, Feagan BG, Penney M, Rees WA, Danese S, Higgins PDR, Newbold P, Faggioni R, Patra K, Li J, Klekotka P, Morehouse C, Pulkstenis E, Drappa J, van der Merwe R, Gasser RA Jr. Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn's Disease: A Phase 2a Study. Gastroenterology. 2017 Jul;153(1):77-86.e6. doi: 10.1053/j.gastro.2017.03.049. Epub 2017 Apr 5. | |
| 38124112 |
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Out of 174 screened subjects, 53 were considered screen failures. A total of 121 subjects were randomized, of which 2 did not receive study drug. Those 2 subjects were not included in the mITT population; therefore, those subjects are not counted in the participant flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4. |
| FG001 | Experimental: MEDI2070 700mg | Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blinded Induction Period |
|
Not provided
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| placebo |
| Drug |
1 iv infusion on Week 0 and Week 4 |
|
| Week 8 |
| Percentage of Participants With CDAI Response at Week 12 | The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI response is defined by either a CDAI score of < 150 or a CDAI reduction from baseline of at least 100 points, where baseline was the latest non-missing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point. | Week 12 |
| Percentage of Participants With CDAI Remission at Week 8 | The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. The CDAI score of < 150 represent CDAI remission. Subjects in the mITT population were analysed for this end point. | Week 8 |
| Percentage of Participants With CDAI-100 Point Improvement at Week 8 | The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 100-point improvement is defined as a reduction from baseline in CDAI score of at least 100 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point. | Week 8 |
| Change From Baseline in CDAI Total Score at Week 8 | The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. Subjects in the mITT population were analysed for this end point. | Week 8 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period | An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug. | From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks) |
| Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period | An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug. | From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks) |
| Number of Participants With TEAEs in Open-label Period | An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment. | From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks) |
| Number of Participants With TESAEs in Open-label Period | An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment. | From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks) |
| Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period | The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (up to approximately 48 weeks). Subjects in the safety population were analysed for this end point. | From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks) |
| Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period | The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment (up toapproximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment. | From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks) |
| Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period | The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment(approximately 48 weeks). Subjects in the safety population were analysed for this end point. | From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks) |
| Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period | The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment(approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment. | From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks) |
| Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period | Pharmacokinetic (PK) population included all subjects who received at least one dose of MEDI2070(either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frames and is reported by an arbitrary value (NA). | Post-dose on Week 0 (Day 1); pre and post-dose on Week 4; pre-dose on Week 8 |
| Maximum Mean Serum Concentration of MEDI2070 in Open-label Period | The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for pre-dose Week 12 time frame and is reported by an arbitrary value (NA). | Pre-dose on Weeks 12, 24, and 112 |
| Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period | The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. | Baseline (Week0/Day 1) up to 28 week post last dose (approximately 40 weeks) |
| Number of Participants With ADA Positive to MEDI2070 in Open-label Period | The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. | Up to 28 week post last dose (approximately 140 weeks) |
| Los Angeles |
| California |
| 45242 |
| United States |
| Research Site | San Diego | California | 92114 | United States |
| Research Site | Torrance | California | 90505 | United States |
| Research Site | Lakewood | Colorado | 80215 | United States |
| Research Site | Jacksonville | Florida | 32256 | United States |
| Research Site | Miami | Florida | 33136 | United States |
| Research Site | Winter Park | Florida | 32789 | United States |
| Research Site | Macon | Georgia | 31201 | United States |
| Research Site | Chicago | Illinois | 60637 | United States |
| Research Site | Baton Rouge | Louisiana | 70809 | United States |
| Research Site | Hammond | Louisiana | 70403 | United States |
| Research Site | Baltimore | Maryland | 21201 | United States |
| Research Site | Chevy Chase | Maryland | 20815 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Troy | Michigan | 48098 | United States |
| Research Site | Belton | Missouri | 64012 | United States |
| Research Site | New York | New York | 10021 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | Asheville | North Carolina | 28801 | United States |
| Research Site | Charlotte | North Carolina | 28207 | United States |
| Research Site | Cincinnati | Ohio | 45219 | United States |
| Research Site | Lima | Ohio | 45806 | United States |
| Research Site | Germantown | Tennessee | 38138 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Seattle | Washington | 98195 | United States |
| Research Site | Edmonton | Alberta | T6G 2X8 | Canada |
| Research Site | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Research Site | Guelph | Ontario | N1H 3R3 | Canada |
| Research Site | Kingston | Ontario | K7L 5G2 | Canada |
| Research Site | London | Ontario | N6A 5A5 | Canada |
| Research Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Research Site | Toronto | Ontario | M5G 1X5 | Canada |
| Research Site | Toronto | Ontario | M6H 3M1 | Canada |
| Research Site | Vaughan | Ontario | L4L 4Y7 | Canada |
| Research Site | Montreal | Quebec | H3A 1A1 | Canada |
| Research Site | České Budějovice | 370 01 | Czechia |
| Research Site | Hradec Králové | 500 12 | Czechia |
| Research Site | Litoměřice | 412 01 | Czechia |
| Research Site | Ostrava-Poruba | 708 53 | Czechia |
| Research Site | Prague | 100 34 | Czechia |
| Research Site | Prague | 170 04 | Czechia |
| Research Site | Amiens | 88054 | France |
| Research Site | Clichy | 92210 | France |
| Research Site | Pessac | 33604 | France |
| Research Site | Rouen | F-76031 CE | France |
| Research Site | Toulouse | 31059 | France |
| Research Site | Hamburg | 20246 | Germany |
| Research Site | Hamburg | 20249 | Germany |
| Research Site | München | 80331 | Germany |
| Research Site | Potsdam | 14482 | Germany |
| Research Site | Budapest | 1062 | Hungary |
| Research Site | Budapest | 1081 | Hungary |
| Research Site | Budapest | 1125 | Hungary |
| Research Site | Kaposvár | 7400 | Hungary |
| Research Site | Szombathely | 9700 | Hungary |
| Research Site | Bologna | 40138 | Italy |
| Research Site | Florence | 50141 | Italy |
| Research Site | Milan | 20100 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Roma | 133 | Italy |
| Research Site | Roma | 196 | Italy |
| Research Site | Rozzano | 20089 | Italy |
| Research Site | Bydgoszcz | 85-168 | Poland |
| Research Site | Bydgoszcz | 85-681 | Poland |
| Research Site | Opole | 45-061 | Poland |
| Research Site | Rzeszów | 35-301 | Poland |
| Research Site | Sopot | 81-756 | Poland |
| Research Site | Sosnowiec | Poland |
| Research Site | Warsaw | 02-507 | Poland |
| Research Site | Wroclaw | 53-333 | Poland |
| Research Site | Barcelona | 8025 | Spain |
| Research Site | Barcelona | 8035 | Spain |
| Research Site | Barcelona | 8916 | Spain |
| Research Site | L'Hospitalet de Llobregat | 8907 | Spain |
| Research Site | Sabadell(Barcelona) | 8208 | Spain |
| Research Site | Seville | 41014 | Spain |
| Research Site | Seville | 41071 | Spain |
| Research Site | Valencia | 46026 | Spain |
| Derived |
| Danese S, Beaton A, Duncan EA, Mercier AK, Neisen J, Seth H, Zetterstrand S, Sands BE. Long-term safety of brazikumab in the open-label period of a randomized phase 2a study of patients with Crohn's disease. BMC Gastroenterol. 2023 Dec 20;23(1):451. doi: 10.1186/s12876-023-03078-7. |
| FG002 | Placebo/MEDI2070 210mg | Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period. |
| FG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| Open-Label Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4. |
| BG001 | Experimental: MEDI2070 700mg | Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants With CDAI-70 Point Improvement at Week 8 | The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 70-point improvement is defined as a reduction from baseline in CDAI score of at least 70 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point. | Value of 0 represents the open-label portion of the trial | Posted | Number | Percentage of Participants | Week 8 |
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| Secondary | Percentage of Participants With CDAI Response at Week 12 | The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI response is defined by either a CDAI score of < 150 or a CDAI reduction from baseline of at least 100 points, where baseline was the latest non-missing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point. | Value of 0 represents the open-label portion of the trial | Posted | Number | Percentage of Participants | Week 12 |
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| Primary | Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8 | A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (<)150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT)population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period. | Value of 0 represents the open-label portion of the trial | Posted | Number | Percentage of Participants | Week 8 |
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| Secondary | Percentage of Participants With CDAI Remission at Week 8 | The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. The CDAI score of < 150 represent CDAI remission. Subjects in the mITT population were analysed for this end point. | Value of 0 represents the open-label portion of the trial | Posted | Number | Percentage of Participants | Week 8 |
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| Secondary | Percentage of Participants With CDAI-100 Point Improvement at Week 8 | The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 100-point improvement is defined as a reduction from baseline in CDAI score of at least 100 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point. | Value of 0 represents the open-label portion of the trial | Posted | Number | Percentage of Participants | Week 8 |
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| Secondary | Change From Baseline in CDAI Total Score at Week 8 | The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. Subjects in the mITT population were analysed for this end point. | Value of 0 represents the open-label portion of the trial | Posted | Least Squares Mean | Standard Error | Scores on a scale | Week 8 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period | An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug. | Value of 0 represents the open-label portion of the trial | Posted | Count of Participants | Participants | From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks) |
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| Secondary | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period | An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug. | Value of 0 represents the open-label portion of the trial | Posted | Count of Participants | Participants | From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks) |
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| Secondary | Number of Participants With TEAEs in Open-label Period | An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment. | Value of 0 represents the double-blind portion of the trial | Posted | Count of Participants | Participants | From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks) |
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| Secondary | Number of Participants With TESAEs in Open-label Period | An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment. | Value of 0 represents the double-blind portion of the trial | Posted | Count of Participants | Participants | From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks) |
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| Secondary | Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period | The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (up to approximately 48 weeks). Subjects in the safety population were analysed for this end point. | Value of 0 represents the open-label portion of the trial | Posted | Count of Participants | Participants | From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks) |
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| Secondary | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period | The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment (up toapproximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment. | Value of 0 represents the double-blind portion of the trial | Posted | Count of Participants | Participants | From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks) |
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| Secondary | Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period | The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment(approximately 48 weeks). Subjects in the safety population were analysed for this end point. | Value of 0 represents the open-label portion of the trial | Posted | Count of Participants | Participants | From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period | The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment(approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment. | Value of 0 represents the double-blind portion of the trial | Posted | Count of Participants | Participants | From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks) |
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| Secondary | Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period | Pharmacokinetic (PK) population included all subjects who received at least one dose of MEDI2070(either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frames and is reported by an arbitrary value (NA). | Serum MEDI2070 concentration data was summarized descriptively by visit. Value of 0 represents the open-label portion of the trial. | Posted | Mean | Standard Deviation | mcg/ML | Post-dose on Week 0 (Day 1); pre and post-dose on Week 4; pre-dose on Week 8 |
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| Secondary | Maximum Mean Serum Concentration of MEDI2070 in Open-label Period | The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for pre-dose Week 12 time frame and is reported by an arbitrary value (NA). | Serum MEDI2070 concentration data was summarized descriptively by visit. Value of 0 represents the double-blind portion of the trial. | Posted | Mean | Standard Deviation | mcg/ML | Pre-dose on Weeks 12, 24, and 112 |
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| Secondary | Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period | The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. | Value of 0 represents the open-label portion of the trial | Posted | Count of Participants | Participants | Baseline (Week0/Day 1) up to 28 week post last dose (approximately 40 weeks) |
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| Secondary | Number of Participants With ADA Positive to MEDI2070 in Open-label Period | The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. | Value of 0 represents the double-blind portion of the trial | Posted | Count of Participants | Participants | Up to 28 week post last dose (approximately 140 weeks) |
|
From study drug administration (Day 1) to 36 weeks post last dose (approximately 148 weeks)
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 | Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4. | 5 | 60 | 38 | 60 | ||
| EG001 | Experimental: MEDI2070 700mg | Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4. | 5 | 59 | 38 | 59 | ||
| EG002 | Placebo/MEDI2070 210mg | Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period. | 8 | 52 | 43 | 52 | ||
| EG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. | 12 | 52 | 42 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shock | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intestinal anastomosis complication | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Accidental exposure to product | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
A formal statistical analysis was not performed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo. (Note that this agreement language may appear in the study protocol)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Information Center | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000622252 | MEDI2070 |
Not provided
Not provided
Not provided
| Adverse Event |
|
| Withdrawal by Subject |
|
| Developed specific withdrawal criteria |
|
| Lost to Follow-up |
|
| Male |
|
| OG002 |
| Placebo/MEDI2070 210mg |
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period. |
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| OG002 | Placebo/MEDI2070 210mg | Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period. |
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
|
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| OG002 |
| Placebo/MEDI2070 210mg |
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period. |
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| OG002 | Placebo/MEDI2070 210mg | Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period. |
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| OG002 | Placebo/MEDI2070 210mg | Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period. |
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| OG002 | Placebo/MEDI2070 210mg | Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period. |
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| OG002 | Placebo/MEDI2070 210mg | Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period. |
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| OG003 | MEDI2070 700mg/MEDI2070 210mg | Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
| MEDI2070 700mg/MEDI2070 210mg |
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
|
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period. |
|
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