A Phase 2 interventional study of Brazikumab IV Infusion and Brazikumab SC Injection in Crohn's Disease, sponsored by AstraZeneca. Terminated at 97 sites in 12 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFα) therapy.
This is a four-part Phase 2b study comprised of a 16-week, double-blind, placebo-controlled, Induction Period, a 12-week double-blind, placebo-controlled, Maintenance Period, a 24-week, Open-label Period and a post-treatment 28 week observational safety follow-up period designed to evaluate the short-term efficacy and the short- and long term safety of brazikumab in participants with moderate to severe, active Crohn's disease (CD) who have failed or are intolerant to anti-TNFα therapy as determined by the Investigator.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 29 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
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Exclusion Criteria:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Drug: Brazikumab IV Infusion · Drug: Brazikumab SC Injection · Drug: Placebo
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Drug: Brazikumab IV Infusion · Drug: Brazikumab SC Injection · Drug: Placebo
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Drug: Brazikumab IV Infusion · Drug: Brazikumab SC Injection · Drug: Placebo
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Drug: Brazikumab IV Infusion · Drug: Brazikumab SC Injection · Drug: Placebo
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Drug: Brazikumab IV Infusion · Drug: Brazikumab SC Injection · Drug: Placebo
Brazikumab IV infusion as per protocol specified dosing schedule.
Also known as: MEDI2070
Brazikumab IV infusion as per protocol specified dosing schedule.
Also known as: MEDI2070
Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Remission at Week 8
CDAI remission was defined as a CDAI score of \<150 at Week 8. CDAI score was calculated by summing weighted scores for subjective items \[number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)\] recorded by a diary during a 1-week period, and objective items \[associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight\]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time frame: Week 8
Percentage of Participants With Loose/Liquid Stool Frequency Response
Loose/liquid stool frequency response is the stools identified as Type 6 or 7 on Bristol Stool Form Scale, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline. The participant recorded their stool consistency each day in a daily patient diary using the Bristol Stool Form Scale. It is a scale between 1-7, it measured the shape of the stool, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool.
Time frame: Baseline, Weeks 8, 16 and 28
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response
CDAI response was defined as a decrease from baseline in the CDAI score of ≥100. CDAI score was calculated by summing weighted scores for subjective items \[number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)\] recorded by a diary during a 1-week period, and objective items \[associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight\]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time frame: Baseline, Weeks 8, 16 and 28
Percentage of Participants With CDAI Clinical Remission
CDAI clinical remission was defined as a CDAI score of \<150. CDAI score was calculated by summing weighted scores for subjective items \[number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)\] recorded by a diary during a 1-week period, and objective items \[associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight\]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time frame: Weeks 16 and 28
Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Response
SES-CD response was defined as a decrease from baseline in SES-CD score of ≥ 50%. The SES-CD evaluates 4 endoscopic variables \[ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis\] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy \[ileum, right colon, transverse colon, left colon, and rectum\]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicates more severe disease.
Time frame: Baseline, Weeks 16 and 28
Percentage of Participants With Loose/Liquid Stool Frequency Remission
Loose/liquid stool frequency response is the stools identified as Type 6 or 7 on Bristol Stool Form Scale, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline. The participant recorded their stool consistency each day in a daily patient diary using the Bristol Stool Form Scale. It is a scale between 1-7, it measured the shape of the stool, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool.
Time frame: Baseline, Weeks 8, 16 and 28
Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Remission
SES-CD remission was defined as a Total SES-CD score of ≤4 and no subscore \>2. The SES-CD evaluates 4 endoscopic variables \[ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis\] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy \[ileum, right colon, transverse colon, left colon, and rectum\]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicates more severe disease.
Time frame: Weeks 16 and 28
Percentage of Participants With Patient Response Outcome-2 (PRO2) Remission
PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain (on an 11-point scale where 0=no pain to 10=worst imaginable pain). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO2-remission was defined as PRO2 less than 8 points. PRO2 is a composite index consisting of weighted scoring of both variables. PRO2 scores ranges from 0 to approximately 45, higher score indicates higher disease activity.
Time frame: Weeks 8, 16 and 28
Percentage of Participants With PRO2 Response
PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain. PRO2 response was defined as remission or response in one symptom (either abdominal pain or stool frequency) plus response in the other: a) abdominal pain remission: On an 11-point (0 to 10) pain scale: During 1 week, no daily score \> 2, b) abdominal pain response: On an 11-point (0 to 10) pain scale: ≥ 30% reduction in weekly pain score from baseline, c) loose/liquid stool frequency remission: Counting stools identified as Type 6 or 7 on Bristol Stool Form Scale (BSFS), (The BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool), during 1 week, each daily loose/liquid stool count ≤ 3, d) loose/liquid stool frequency response: Counting stools identified as Type 6 or 7 on BSFS, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline.
Time frame: Baseline, Weeks 8, 16 and 28
Serum Interleukin (IL)-22 and Serum Lipocalin 2 (LCN2) Concentration as a Biomarker of Brazikumab's Efficacy
Time frame: Weeks 16 and 28
Percentage of Participants With CDAI Modified Sustained Clinical Remission at Both Weeks 8 and 28
CDAI modified sustained clinical remission was defined as a CDAI score of \<150 at both Weeks 8 and 28. CDAI score was calculated by summing weighted scores for subjective items \[number of liquid or very soft stools, abdominal pain (on a scale of 0=mild to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)\] recorded by a diary during a 1-week period, and objective items \[associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature and body weight\]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time frame: Weeks 8 and 28
Serum Brazikumab Concentration
Time frame: Predose at Weeks 0, 1, 4, 8, 12, 16, 28; Postdose at Weeks 0 and 4
Number of Participants With Serum Anti-drug Antibodies for Brazikumab
Time frame: Predose at Weeks 0, 4, 12, 16, 28, 40 and 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of Special Interest and TEAEs Leading to Discontinuation
An AE is any untoward medical occurrence in a patient/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not related to the investigational product. A TEAE is any new AE or worsening of an existing condition after initiation of treatment. An SAE is an AE that resulted in death, inpatient hospitalization/prolongation of existing hospitalization, persistent or significant disability or incapacity, life threatening, a congenital anomaly/birth defect, or an important medical event. AE of special interest were infusion/injection-site reactions, hypersensitivity reactions, malignancies, cardiac events like myocardial infarction, stroke/cardiovascular death, ocular AE including cataracts.
Time frame: From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)
Number of Participants With Clinically Significant Laboratory Values
Laboratory parameters included tests for hematology, serum chemistry and urinalysis. Laboratory values that were outside the reference range, considered clinically significant were reported.
Time frame: From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)
Percentage of Participants With Abdominal Pain Response
Abdominal pain response is defined as a ≥ 30% reduction in weekly pain score from baseline on an 11-point (0 to 10) pain scale, where 0 = no pain and 10 = worst imaginable pain.
Time frame: Baseline; Weeks 8, 16 and 28
Percentage of Participants With Abdominal Pain Remission
Abdominal pain remission is defined as no daily score \> 2 on an 11-point (0 to 10) pain scale during 1 week, where 0 = no pain and 10 = worst imaginable pain.
Time frame: Weeks 8, 16 and 28
| Milestone | Double Blind (DB): Placebo | DB: Brazikumab High Dose | DB: Brazikumab High-Medium Dose | DB: Brazikumab Low-Medium Dose | DB: Brazikumab Low Dose | Open-label (OL): Placebo/Brazikumab 210 mg | OL: Brazikumab High Dose/Brazikumab 210 mg | OL: Brazikumab High- Medium Dose/Brazikumab 210 mg | OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg | OL: Brazikumab Low Dose/Brazikumab 210 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 5 | 5 | 9 | 7 | 3 | 0 | 0 | 0 | 0 | 0 |
| Completed | 2 | 4 | 2 | 3 | 1 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 3 | 1 | 7 | 4 | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol deviation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Non-compliance with study drug | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 1 | 1 | 5 | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Reason not specified | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Double Blind (DB): Placebo | DB: Brazikumab High Dose | DB: Brazikumab High-Medium Dose | DB: Brazikumab Low-Medium Dose | DB: Brazikumab Low Dose | Open-label (OL): Placebo/Brazikumab 210 mg | OL: Brazikumab High Dose/Brazikumab 210 mg | OL: Brazikumab High- Medium Dose/Brazikumab 210 mg | OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg | OL: Brazikumab Low Dose/Brazikumab 210 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 2 | 3 | 2 | 3 | 1 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 2 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 1 | 0 |
CDAI remission was defined as a CDAI score of \<150 at Week 8. CDAI score was calculated by summing weighted scores for subjective items \[number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)\] recorded by a diary during a 1-week period, and objective items \[associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight\]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
| percentage of participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Percentage of Participants With Crohn's Disease Activity Index (CDAI) Remission at Week 8 | 0.0 | 0.0 | 22.2 | 0.0 | 33.3 |
Loose/liquid stool frequency response is the stools identified as Type 6 or 7 on Bristol Stool Form Scale, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline. The participant recorded their stool consistency each day in a daily patient diary using the Bristol Stool Form Scale. It is a scale between 1-7, it measured the shape of the stool, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool.
| percentage of participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Week 8 | 50.0 | 40.0 | 55.6 | 14.3 | 66.7 |
| Week 16 | 50.0 | 60.0 | 66.7 | 0.0 | 33.3 |
| Week 28 | 25.0 | 20.0 | 33.3 | 0.0 | 33.3 |
CDAI response was defined as a decrease from baseline in the CDAI score of ≥100. CDAI score was calculated by summing weighted scores for subjective items \[number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)\] recorded by a diary during a 1-week period, and objective items \[associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight\]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
| percentage of participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Week 8 | 0.0 | 60.0 | 77.8 | 28.6 | 66.7 |
| Week 16 | 25.0 | 60.0 | 55.6 | 14.3 | 33.3 |
| Week 28 | 0.0 | 50.0 | 11.1 | 14.3 | 33.3 |
CDAI clinical remission was defined as a CDAI score of \<150. CDAI score was calculated by summing weighted scores for subjective items \[number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)\] recorded by a diary during a 1-week period, and objective items \[associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight\]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
| percentage of participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Week 16 | 25.5 | 20.0 | 22.2 | 14.3 | 33.3 |
| Week 28 | 25.0 | 0.0 | 0.0 | 0.0 | 33.3 |
SES-CD response was defined as a decrease from baseline in SES-CD score of ≥ 50%. The SES-CD evaluates 4 endoscopic variables \[ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis\] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy \[ileum, right colon, transverse colon, left colon, and rectum\]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicates more severe disease.
| percentage of participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Week 16 | 0.0 | 40.0 | 44.4 | 14.3 | 0.0 |
| Week 28 | 0.0 | 40.0 | 11.1 | 14.3 | 33.3 |
Loose/liquid stool frequency response is the stools identified as Type 6 or 7 on Bristol Stool Form Scale, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline. The participant recorded their stool consistency each day in a daily patient diary using the Bristol Stool Form Scale. It is a scale between 1-7, it measured the shape of the stool, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool.
| percentage of participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Week 8 | 75.0 | 60.0 | 55.6 | 28.6 | 100.0 |
| Week 16 | 50.0 | 60.0 | 55.6 | 14.3 | 66.7 |
| Weeks 28 | 50.0 | 20.0 | 33.3 | 14.3 | 33.3 |
SES-CD remission was defined as a Total SES-CD score of ≤4 and no subscore \>2. The SES-CD evaluates 4 endoscopic variables \[ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis\] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy \[ileum, right colon, transverse colon, left colon, and rectum\]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicates more severe disease.
| percentage of participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Week 16 | 0.0 | 20.0 | 22.2 | 0.0 | 0.0 |
| Week 28 | 0.0 | 20.0 | 11.1 | 0.0 | 0.0 |
PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain (on an 11-point scale where 0=no pain to 10=worst imaginable pain). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO2-remission was defined as PRO2 less than 8 points. PRO2 is a composite index consisting of weighted scoring of both variables. PRO2 scores ranges from 0 to approximately 45, higher score indicates higher disease activity.
| percentage of participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Week 8 | 0.0 | 20.0 | 11.1 | 0.0 | 0.0 |
| Week 16 | 0.0 | 20.0 | 0.0 | 0.0 | 0.0 |
| Week 28 | 25.0 | 0.0 | 11.1 | 0.0 | 0.0 |
PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain. PRO2 response was defined as remission or response in one symptom (either abdominal pain or stool frequency) plus response in the other: a) abdominal pain remission: On an 11-point (0 to 10) pain scale: During 1 week, no daily score \> 2, b) abdominal pain response: On an 11-point (0 to 10) pain scale: ≥ 30% reduction in weekly pain score from baseline, c) loose/liquid stool frequency remission: Counting stools identified as Type 6 or 7 on Bristol Stool Form Scale (BSFS), (The BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool), during 1 week, each daily loose/liquid stool count ≤ 3, d) loose/liquid stool frequency response: Counting stools identified as Type 6 or 7 on BSFS, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline.
| percentage of participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Week 8 | 50.0 | 20.0 | 33.3 | 0.0 | 66.7 |
| Week 16 | 50.0 | 40.0 | 66.7 | 0.0 | 66.7 |
| Week 28 | 50.0 | 0.0 | 33.3 | 0.0 | 33.3 |
No measurements were reported for this outcome.
CDAI modified sustained clinical remission was defined as a CDAI score of \<150 at both Weeks 8 and 28. CDAI score was calculated by summing weighted scores for subjective items \[number of liquid or very soft stools, abdominal pain (on a scale of 0=mild to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)\] recorded by a diary during a 1-week period, and objective items \[associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature and body weight\]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
No measurements were reported for this outcome.
| nanograms per milliliters (ng/mL) | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|
| Week 0, Predose | 307 ± 686 | 3213 ± 9639 | 7 ± 19 | 0 ± 0 |
| Week 0, Postdose | 448085 ± 151153 | 149388 ± 75443 | 0 ± 0 | 0 ± 0 |
| Week 1, Predose | 124239 ± 19941 | 51335 ± 16422 | 20740 ± 10744 | 14073 ± 5896 |
| Week 4, Predose | 56798 ± 25064 | 17741 ± 4622 | 11201 ± 6084 | 5290 ± 266 |
| Week 4, Postdose | 390820 ± 60355 | 17252 ± 10812 | 11383 ± 5853 | 7555 ± 4178 |
| Week 8, Predose | 77747 ± 30129 | 13997 ± 4467 | 10850 ± 4191 | 7982 ± 5967 |
| Week 12, Predose | 50667 ± 16704 | 19076 ± 11823 | 11554 ± 4505 | 6031 ± 3528 |
| Week 16, Predose | 33247 ± 12890 | 26321 ± 16994 | 13920 ± 5340 | 6404 ± 1768 |
| Week 28, Predose | 31067 ± 8738 | 13713 ± 2072 | 10842 ± 6641 | 6988 ± NA |
| Participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Week 0 | 0 | 1 | 0 | 0 | 0 |
| Week 4 | 0 | 0 | 1 | 0 | 0 |
| Week 12 | 0 | 1 | 0 | 0 | 0 |
| Week 16 | 0 | 0 | 0 | 0 | 0 |
| Week 28 | 0 | 0 | 0 | 0 | 0 |
| Week 40 | 0 | 0 | 0 | 0 | — |
| Week 52 | — | 0 | 0 | 0 | — |
An AE is any untoward medical occurrence in a patient/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not related to the investigational product. A TEAE is any new AE or worsening of an existing condition after initiation of treatment. An SAE is an AE that resulted in death, inpatient hospitalization/prolongation of existing hospitalization, persistent or significant disability or incapacity, life threatening, a congenital anomaly/birth defect, or an important medical event. AE of special interest were infusion/injection-site reactions, hypersensitivity reactions, malignancies, cardiac events like myocardial infarction, stroke/cardiovascular death, ocular AE including cataracts.
| Participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| TEAEs | 5 | 4 | 8 | 7 | 2 |
| TESAEs | 0 | 1 | 0 | 2 | 1 |
| TEAEs of Special Interest | 0 | 0 | 0 | 1 | 1 |
| TEAEs Leading to Discontinuation | 1 | 0 | 0 | 1 | 0 |
Laboratory parameters included tests for hematology, serum chemistry and urinalysis. Laboratory values that were outside the reference range, considered clinically significant were reported.
| Participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Number of Participants With Clinically Significant Laboratory Values | 0 | 0 | 0 | 0 | 0 |
Abdominal pain response is defined as a ≥ 30% reduction in weekly pain score from baseline on an 11-point (0 to 10) pain scale, where 0 = no pain and 10 = worst imaginable pain.
| percentage of participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Week 8 | 50.0 | 40.0 | 44.4 | 28.6 | 66.7 |
| Week 16 | 50.0 | 60.0 | 66.7 | 28.6 | 100.0 |
| Week 28 | 50.0 | 0.0 | 33.3 | 0.0 | 33.3 |
Abdominal pain remission is defined as no daily score \> 2 on an 11-point (0 to 10) pain scale during 1 week, where 0 = no pain and 10 = worst imaginable pain.
| percentage of participants | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose |
|---|---|---|---|---|---|
| Week 8 | 0.0 | 20.0 | 11.1 | 0.0 | 0.0 |
| Week 16 | 0.0 | 40.0 | 0.0 | 0.0 | 0.0 |
| Week 28 | 25.0 | 0.0 | 11.1 | 0.0 | 0.0 |
Collected over From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DB: Placebo | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| DB: Brazikumab High Dose | 0/5 (0%) | 1/5 (20%) | 4/5 (80%) |
| DB: Brazikumab High-Medium Dose | 0/9 (0%) | 0/9 (0%) | 8/9 (88.9%) |
| DB: Brazikumab Low-Medium Dose | 0/7 (0%) | 1/7 (14.3%) | 7/7 (100%) |
| DB: Brazikumab Low Dose | 0/3 (0%) | 1/3 (33.3%) | 1/3 (33.3%) |
| OL: Placebo/Brazikumab 210 mg | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| OL: Brazikumab High Dose/Brazikumab 210 mg | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| OL: Brazikumab High-Medium Dose/Brazikumab 210 mg | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg | 0/3 (0%) | 1/3 (33.3%) | 1/3 (33.3%) |
| OL: Brazikumab Low Dose/Brazikumab 210 mg | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | DB: Placebo | DB: Brazikumab High Dose | DB: Brazikumab High-Medium Dose | DB: Brazikumab Low-Medium Dose | DB: Brazikumab Low Dose | OL: Placebo/Brazikumab 210 mg | OL: Brazikumab High Dose/Brazikumab 210 mg | OL: Brazikumab High-Medium Dose/Brazikumab 210 mg | OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg | OL: Brazikumab Low Dose/Brazikumab 210 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Crohn's diseaseGastrointestinal disorders | 0/5 | 0/5 | 0/9 | 1/7 | 1/3 | 0/2 | 0/3 | 0/2 | 0/3 | 0/1 |
| Ischaemic strokeNervous system disorders | 0/5 | 0/5 | 0/9 | 0/7 | 0/3 | 0/2 | 0/3 | 0/2 | 1/3 | 0/1 |
| PneumoniaInfections and infestations | 0/5 | 1/5 | 0/9 | 0/7 | 0/3 | 0/2 | 0/3 | 0/2 | 0/3 | 0/1 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/5 | 0/5 | 0/9 | 1/7 | 0/3 | 0/2 | 0/3 | 0/2 | 0/3 | 0/1 |
| Event | DB: Placebo | DB: Brazikumab High Dose | DB: Brazikumab High-Medium Dose | DB: Brazikumab Low-Medium Dose | DB: Brazikumab Low Dose | OL: Placebo/Brazikumab 210 mg | OL: Brazikumab High Dose/Brazikumab 210 mg | OL: Brazikumab High-Medium Dose/Brazikumab 210 mg | OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg | OL: Brazikumab Low Dose/Brazikumab 210 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 0/5 | 2/5 | 0/9 | 0/7 | 0/3 | 1/2 | 0/3 | 0/2 | 0/3 | 0/1 |
| RashSkin and subcutaneous tissue disorders | 0/5 | 0/5 | 0/9 | 1/7 | 0/3 | 0/2 | 0/3 | 1/2 | 1/3 | 0/1 |
| Abdominal discomfortGastrointestinal disorders | 0/5 | 0/5 | 0/9 | 0/7 | 0/3 | 1/2 | 0/3 | 0/2 | 0/3 | 0/1 |
| Anal fissureGastrointestinal disorders | 0/5 | 0/5 | 0/9 | 0/7 | 0/3 | 1/2 | 0/3 | 0/2 | 0/3 | 0/1 |
| ConstipationGastrointestinal disorders | 0/5 | 0/5 | 0/9 | 0/7 | 0/3 | 1/2 | 0/3 | 0/2 | 0/3 | 0/1 |
| EnterobiasisInfections and infestations | 0/5 | 0/5 | 0/9 | 0/7 | 0/3 | 0/2 | 0/3 | 1/2 | 0/3 | 0/1 |
| GastroenteritisInfections and infestations | 0/5 | 0/5 | 0/9 | 0/7 | 0/3 | 1/2 | 0/3 | 0/2 | 0/3 | 0/1 |
| Iron deficiencyMetabolism and nutrition disorders | 0/5 | 0/5 | 0/9 | 0/7 | 0/3 | 1/2 | 0/3 | 0/2 | 0/3 | 0/1 |
| Melanocytic naevusNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/5 | 0/5 | 0/9 | 0/7 | 0/3 | 1/2 | 0/3 | 0/2 | 0/3 | 0/1 |
| StressPsychiatric disorders | 0/5 | 0/5 | 0/9 | 0/7 | 0/3 | 1/2 | 0/3 | 0/2 | 0/3 | 0/1 |
Intent-to-treat (ITT) population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period.
| Age, Continuous(years) | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose | Total |
|---|---|---|---|---|---|---|
| Mean | 35.3 ± 10.34 | 37.2 ± 13.29 | 38.3 ± 15.03 | 39.9 ± 13.89 | 40.7 ± 11.37 | 38.3 ± 12.66 |
| Sex: Female, Male(Participants) | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose | Total |
|---|---|---|---|---|---|---|
| Female | 2 | 3 | 6 | 4 | 1 | 16 |
| Male | 2 | 2 | 3 | 3 | 2 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 2 | 0 | 2 |
| Not Hispanic or Latino | 4 | 5 | 8 | 5 | 3 | 25 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Placebo | Brazikumab High Dose | Brazikumab High-Medium Dose | Brazikumab Low-Medium Dose | Brazikumab Low Dose | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 | 0 | 2 |
| White | 3 | 5 | 8 | 6 | 3 | 25 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 1 |
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