Crohn's DiseasePhase 2NCT01714726
Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.
A Phase 2 study testing MEDI2070 in people with Crohn's Disease, run by AstraZeneca at 80 sites in 9 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- MEDI2070
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 80 sitesin 9 countries
- Study dates
- 1 Feb 2013to 14 Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening.
- Men or women age 18 - 65 years at the time of screening.
- Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity Index (CDAI) score higher or equal 220 and lower or equal 450 at Day 1.
- No known history of active tuberculosis (TB).
- Received at least one anti-TNFα agent for the treatment of CD and did not initially respond.
Who cannot join
- Pregnant or breastfeeding women.
- Presence of ileostomy and/or colostomy.
- Short bowel syndrome.
- Bowel perforation or obstruction.
- History of cancer.
Trial locations and contacts
80 sites in 9 countries.
80 sites in 9 countries
United States26 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Asheville, North Carolina, 28801
Research Site
Baltimore, Maryland, 21201
Research Site
Baton Rouge, Louisiana, 70809
Research Site
Belton, Missouri, 64012
Research Site
Charlotte, North Carolina, 28207
Research Site
Chevy Chase, Maryland, 20815
Research Site
Chicago, Illinois, 60637
Research Site
Cincinnati, Ohio, 45219
Research Site
Encinitas, California, 92024
Research Site
Germantown, Tennessee, 38138
Research Site
Hammond, Louisiana, 70403
Research Site
Jacksonville, Florida, 32256
Research Site
Lakewood, Colorado, 80215
Research Site
Lima, Ohio, 45806
Research Site
Los Angeles, California, 45242
Research Site
Macon, Georgia, 31201
Research Site
Miami, Florida, 33136
Research Site
New York, New York, 10021
Research Site
New York, New York, 10029
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92114
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Seattle, Washington, 98195
Research Site
Torrance, California, 90505
Research Site
Troy, Michigan, 48098
Research Site
Winter Park, Florida, 32789
Canada11 sites
Research Site
Edmonton, Alberta, T6G 2X8
Research Site
Guelph, Ontario, N1H 3R3
Research Site
Kingston, Ontario, K7L 5G2
Research Site
London, Ontario, N6A 5A5
Research Site
Montreal, Quebec, H3A 1A1
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6
Research Site
Toronto, Ontario, M5G 1X5
Research Site
Toronto, Ontario, M6H 3M1
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Vancouver, British Columbia, V6Z 2K5
Research Site
Vaughan, Ontario, L4L 4Y7
Poland8 sites
Research Site
Bydgoszcz, 85-168
Research Site
Bydgoszcz, 85-681
Research Site
Opole, 45-061
Research Site
Rzeszów, 35-301
Research Site
Sopot, 81-756
Research Site
Sosnowiec
Research Site
Warsaw, 02-507
Research Site
Wroclaw, 53-333
Spain8 sites
Research Site
Barcelona, 8025
Research Site
Barcelona, 8035
Research Site
Barcelona, 8916
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L'Hospitalet de Llobregat, 8907
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Sabadell(Barcelona), 8208
Research Site
Seville, 41014
Research Site
Seville, 41071
Research Site
Valencia, 46026
Italy7 sites
Research Site
Bologna, 40138
Research Site
Florence, 50141
Research Site
Milan, 20100
Research Site
Naples, 80131
Research Site
Roma, 133
Research Site
Roma, 196
Research Site
Rozzano, 20089
Czechia6 sites
Research Site
České Budějovice, 370 01
Research Site
Hradec Králové, 500 12
Research Site
Litoměřice, 412 01
Research Site
Ostrava-Poruba, 708 53
Research Site
Prague, 100 34
Research Site
Prague, 170 04
France5 sites
Research Site
Amiens, 88054
Research Site
Clichy, 92210
Research Site
Pessac, 33604
Research Site
Rouen, F-76031 CE
Research Site
Toulouse, 31059
Hungary5 sites
Research Site
Budapest, 1062
Research Site
Budapest, 1081
Research Site
Budapest, 1125
Research Site
Kaposvár, 7400
Research Site
Szombathely, 9700
Germany4 sites
Research Site
Hamburg, 20246
Research Site
Hamburg, 20249
Research Site
München, 80331
Research Site
Potsdam, 14482
About this study
Official title: A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
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
Read the detailed description
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.
- Conditions
- Crohn's Disease
- Being tested
- MEDI2070, placebo
- Keywords
- MEDI2070, inflammatory bowel disease, moderate to severe Crohn's disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI2070Drug
1 iv infusion on Week 0 and Week 4
placeboDrug
1 iv infusion on Week 0 and Week 4
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI2070 iv infusion Receives: Drug: MEDI2070 |
| 2 | Placebo comparator | placebo iv infusion Receives: Drug: placebo |
| open-label | Experimental | MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period Receives: Drug: MEDI2070 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 28 week post last dose (approximately 140 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study start1 Feb 2013
- Primary completion20 May 2014
- Study completion14 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedImmune Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714726
- Sponsor's protocol ID
- D5170C00001
- Other IDs
- EudraCT number: 2012-004098-26, 2012-004098-26
- Status last verified
- May 2021
- First submitted
- 24 Oct 2012
- Last updated
- 26 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 28390867Danese 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.
PubMed 38124112
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
- ClinicalTrials.gov ID
- NCT01714726
- Acronym / sponsor ID
- D5170C00001
- Conditions
- Crohn's Disease
- Keywords
- MEDI2070, inflammatory bowel disease, moderate to severe Crohn's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- MedImmune Ltd
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 20 May 2014 (actual)
- Study completion
- 14 Dec 2016 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Posted 6 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEDI2070MEDI2070 iv infusion |
| 2 | Placebo comparator | Drug: placeboplacebo iv infusion |
| open-label | Experimental | Drug: MEDI2070MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening.
- Men or women age 18 - 65 years at the time of screening.
- Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity Index (CDAI) score higher or equal 220 and lower or equal 450 at Day 1.
- No known history of active tuberculosis (TB).
- Received at least one anti-TNFα agent for the treatment of CD and did not initially respond.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women.
- Presence of ileostomy and/or colostomy.
- Short bowel syndrome.
- Bowel perforation or obstruction.
- History of cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI20701 iv infusion on Week 0 and Week 4 | Drug | 1, open-label |
| placebo1 iv infusion on Week 0 and Week 4 | Drug | 2 |
Primary outcome
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8
Time frame: 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.
17 secondary outcomes
Percentage of Participants With CDAI-70 Point Improvement at Week 8
Time frame: Week 8
Percentage of Participants With CDAI Response at Week 12
Time frame: Week 12
Percentage of Participants With CDAI Remission at Week 8
Time frame: Week 8
Percentage of Participants With CDAI-100 Point Improvement at Week 8
Time frame: Week 8
Change From Baseline in CDAI Total Score at Week 8
Time frame: Week 8
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-dose on Weeks 12, 24, and 112
Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period
Time frame: 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
Time frame: Up to 28 week post last dose (approximately 140 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28390867Sands 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.
- Derived from this study: PubMed 38124112Danese 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
80 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI2070 in people with Crohn's Disease, run by AstraZeneca at 80 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, Canada, Poland, Spain, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714726, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.