Crohn's DiseasePhase 2NCT01696396
Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease
A Phase 2 study testing Abrilumab in people with Crohn's Disease, run by Amgen at 84 sites in 12 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI < 150) after treatment for 8 weeks. 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?
- Abrilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 84 sitesin 12 countries
- Study dates
- 4 Dec 2012to 10 Apr 2018
- 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 with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to baseline
- Moderately to severely active Crohn's disease defined by a CDAI score ≥ 220 and ≤ 450 at baseline
- Evidence of active inflammation within 12 weeks prior to baseline
- Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following agents: Immunomodulators and/or anti-tumor necrosis factor (TNF) agents or to corticosteroids (non-US sites only).
- Neurological exam free of clinically significant, unexplained signs or symptoms during screening and no clinically significant change prior to randomization
- Subject has no known history of active tuberculosis and has a negative test for tuberculosis during screening
Who cannot join
- Short bowel syndrome
- Stricture with obstructive symptoms within 3 months
- Bowel surgery within 12 weeks prior baseline, or has planned bowel surgery within 24 weeks from baseline
- Ileostomy and/or colostomy
- Any gastric or intestinal pouch
- Evidence of an infected abscess
Show all 17Show fewer
- Bowel perforation or evidence of non-inflammatory obstruction during the 6 months prior to baseline
- Stool positive for C. difficile toxin at screening
- Any uncontrolled or clinically significant systemic disease
- Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV)
- Any underlying condition that predisposes subject to infections
- Subject has malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of baseline
- Received an anti-TNF agent, cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus, topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids, intravenous or intramuscular corticosteroids within protocol-specified time periods.
- Any prior exposure to antagonists of integrins or integrin ligands (eg, natalizumab, efalizumab, or vedolizumab), rituximab, or TNF kinoid immunotherapies, AMG 181, or any form of cell-based transplantation
- Received treatment of infection with intravenous (within 30 days of baseline) or oral (within 14 days prior to baseline) antibiotics, antivirals, or antifungals
- Significant laboratory abnormalities
- Pregnant or breast feeding
Trial locations and contacts
84 sites in 12 countries.
84 sites in 12 countries
United States24 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Arlington Heights, Illinois, 60005
Research Site
Atlanta, Georgia, 30342
Research Site
Birmingham, Alabama, 35216
Research Site
Charlotte, North Carolina, 28210
Research Site
Chesterfield, Michigan, 48047
Research Site
Dothan, Alabama, 36305
Research Site
Germantown, Tennessee, 38138
Research Site
Goodyear, Arizona, 85395
Research Site
Great Neck, New York, 11021
Research Site
Greenville, North Carolina, 27834
Research Site
Jacksonville, Florida, 32256
Research Site
La Jolla, California, 92093
Research Site
Mentor, Ohio, 44060
Research Site
Mexico, Missouri, 65265
Research Site
Mobile, Alabama, 36608
Hospital
New York, New York, 10029
Research Site
New York, New York, 10029
Research Site
Oklahoma City, Oklahoma, 73103
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Phoenix, Arizona, 85012
Research Site
Rochester, Minnesota, 55905
Research Site
Sanford, Florida, 32771
Research Site
Seattle, Washington, 98101
France9 sites
Research Site
Amiens, 80054
Research Site
Caen, 14033
Research Site
Clichy, 92110
Research Site
Lille, 59037
Research Site
Nice, 06202
Research Site
Paris, 75475
Research Site
Paris, 75571
Research Site
Pessac, 33604
Research Site
Vandœuvre-lès-Nancy, 54511
Canada7 sites
Research Site
Edmonton, Alberta, T6G 2X8
Research Site
Greater Sudbury, Ontario, P3E 1H5
Research Site
London, Ontario, N6A 5A5
Research Site
Saskatoon, Saskatchewan, S7N 0W8
Research Site
Toronto, Ontario, M5G 1X5
Research Site
Vancouver, British Columbia, V5Z 1M9
Research Site
Winnipeg, Manitoba, R3A 1R9
Czechia6 sites
Research Site
Hradec Králové, 500 12
Research Site
Prague, 140 21
Research Site
Prague, 140 59
Research Site
Prague, 150 06
Research Site
Prague, 170 04
Research Site
Ústí nad Labem, 401 13
Denmark6 sites
Research Site
Aalborg, 9000
Research Site
Århus C, 8000
Research Site
Herlev, 2730
Research Site
Hvidovre, 2650
Research Site
Køge, 4600
Research Site
Odense C, 5000
Hungary6 sites
Research Site
Békéscsaba, 5600
Research Site
Budapest, 1088
Research Site
Budapest, 1125
Research Site
Debrecen, 4032
Research Site
Miskolc, 3526
Research Site
Szekszárd, 7100
United Kingdom6 sites
Research Site
Birmingham, B18 7QH
Research Site
Coventry, CV2 2DX
Research Site
London, NW1 2BU
Research Site
Manchester, M8 5RB
Research Site
Norwich, NR4 7UY
Research Site
Torquay, TQ2 7AA
Netherlands5 sites
Research Site
Amsterdam, 1105 AZ
Research Site
Breda, 4818 CK
Research Site
Leiden, 2333 ZA
Research Site
Maastricht, 6229 HX
Research Site
Rotterdam, 3015 CE
Austria4 sites
Research Site
Innsbruck, 6020
Research Site
Sankt Veit an der Glan, 9300
Research Site
Vienna, 1050
Research Site
Vienna, 1090
Belgium4 sites
Research Site
Bonheiden, 2820
Research Site
Brussels, 1200
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Germany4 sites
Research Site
Hamburg, 20148
Research Site
Leipzig, 04105
Research Site
Minden, 32423
Research Site
Stuttgart, 70376
Switzerland3 sites
Research Site
Basel, 4031
Research Site
Bern, 3010
Research Site
Zurich, 8091
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease
The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI < 150) after treatment for 8 weeks.
Read the detailed description
The study consisted of a 24-week double-blind treatment period, a 108-week open-label treatment period, and a 2-year safety follow-up period.
Participants who did not reach minimal improvement, or experienced disease worsening after initial response, had the option to receive open-label abrilumab 210 mg every 3 months (Q3M) beginning at double-blind period week 12 or after. Not reaching minimal improvement was defined as not having an improvement in CDAI score of ≥ 70 points from baseline on 2 consecutive visits (at or after week 8) at least 2 weeks apart. Disease worsening after week 8 (or week 12) response was defined as having an increase in CDAI score of ≥ 70 points from the week 8 (or week 12) CDAI score on 2 consecutive visits at least 2 weeks apart, and a CDAI score of > 150.
Participants were planned to be randomized in a 2:1:2:1 ratio to SC placebo or abrilumab at 21 mg, 70 mg (on day 1, week 2, week 4, and every 4 weeks thereafter until week 24), or 210 mg (on day 1 followed by placebo in weeks 2 and 4 and every 4 weeks thereafter until week 24), respectively. Due to a consistent discrepancy between the investigational product (IP) instruction manual (IPIM) description of vial positions and the actual vial positions in the IP package participants were initially randomized to 3 arms (placebo, 70 mg, and 210 mg) with a randomization ratio of 3:2:1. The study was temporarily paused while this issue was investigated. Once the discrepancy was corrected, Protocol Amendment 3 implemented, and affected participants completed their double-blind treatment period, the study resumed enrollment and randomization per protocol. Neither the randomization nor study blind was compromised and therefore the intent-to-treat principle was maintained.
- Conditions
- Crohn's Disease
- Being tested
- Abrilumab, Placebo
- Keywords
- IBD, Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbrilumabDrug
Also called AMG 181
Administered by subcutaneous injection.
PlaceboDrug
Placebo matching to abrilumab administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo Q4W/Abrilumab 210 mg Q3M | Placebo comparator | Participants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks. Receives: Drug: Abrilumab; Drug: Placebo |
| Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M | Experimental | Participants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks. Receives: Drug: Abrilumab |
| Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M | Experimental | Participants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks. Receives: Drug: Abrilumab |
| Abrilumab 210 mg/Abrilumab 210 mg Q3M | Experimental | Participants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M)for 108 weeks. Receives: Drug: Abrilumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Remission at Week 8
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150 at week 8.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
Measured: Week 8
Secondary outcomes (7)
Percentage of Participants With Remission at Week 12
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
Measured: Week 12
Percentage of Participants With Response at Week 12
Response was defined as either remission (a CDAI score < 150) or a decrease from baseline in the CDAI score of ≥ 100 points.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).
Measured: Baseline and week 12
Percentage of Participants With Response at Week 8
Response was defined as either remission (a CDAI score < 150) or a decrease from baseline in the CDAI score of ≥ 100 points.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).
Measured: Baseline and week 8
Percentage of Participants With Sustained Remission at Both Week 12 and Week 24
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. Sustained remission was defined as achieving the criteria for remission at both week 12 and week 24.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
Measured: Week 12 and week 24
Percentage of Participants With Sustained Remission at Both Week 8 and Week 24
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
Measured: Week 8 and week 24
Change From Baseline in CDAI Score at Week 12
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
Measured: Baseline and week 12
Change From Baseline in CDAI Score at Week 8
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study start4 Dec 2012
- Primary completion26 Dec 2014
- Study completion10 Apr 2018
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 (1)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 AmgenThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696396
- Sponsor's protocol ID
- 20110232
- Other IDs
- 2012-000529-31
- Status last verified
- May 2019
- First submitted
- 27 Sep 2012
- Last updated
- 27 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25.
PubMed 28238174
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT01696396
- Acronym / sponsor ID
- 20110232
- Conditions
- Crohn's Disease
- Keywords
- IBD, Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2012 (actual)
- Primary completion
- 26 Dec 2014 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Posted 27 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI < 150) after treatment for 8 weeks.
Detailed description
The study consisted of a 24-week double-blind treatment period, a 108-week open-label treatment period, and a 2-year safety follow-up period.
Participants who did not reach minimal improvement, or experienced disease worsening after initial response, had the option to receive open-label abrilumab 210 mg every 3 months (Q3M) beginning at double-blind period week 12 or after. Not reaching minimal improvement was defined as not having an improvement in CDAI score of ≥ 70 points from baseline on 2 consecutive visits (at or after week 8) at least 2 weeks apart. Disease worsening after week 8 (or week 12) response was defined as having an increase in CDAI score of ≥ 70 points from the week 8 (or week 12) CDAI score on 2 consecutive visits at least 2 weeks apart, and a CDAI score of > 150.
Participants were planned to be randomized in a 2:1:2:1 ratio to SC placebo or abrilumab at 21 mg, 70 mg (on day 1, week 2, week 4, and every 4 weeks thereafter until week 24), or 210 mg (on day 1 followed by placebo in weeks 2 and 4 and every 4 weeks thereafter until week 24), respectively. Due to a consistent discrepancy between the investigational product (IP) instruction manual (IPIM) description of vial positions and the actual vial positions in the IP package participants were initially randomized to 3 arms (placebo, 70 mg, and 210 mg) with a randomization ratio of 3:2:1. The study was temporarily paused while this issue was investigated. Once the discrepancy was corrected, Protocol Amendment 3 implemented, and affected participants completed their double-blind treatment period, the study resumed enrollment and randomization per protocol. Neither the randomization nor study blind was compromised and therefore the intent-to-treat principle was maintained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Q4W/Abrilumab 210 mg Q3M | Placebo comparator | Drug: Abrilumab, Drug: PlaceboParticipants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks. |
| Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M | Experimental | Drug: AbrilumabParticipants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks. |
| Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M | Experimental | Drug: AbrilumabParticipants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks. |
| Abrilumab 210 mg/Abrilumab 210 mg Q3M | Experimental | Drug: Abrilumab, Drug: PlaceboParticipants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M)for 108 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to baseline
- Moderately to severely active Crohn's disease defined by a CDAI score ≥ 220 and ≤ 450 at baseline
- Evidence of active inflammation within 12 weeks prior to baseline
- Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following agents: Immunomodulators and/or anti-tumor necrosis factor (TNF) agents or to corticosteroids (non-US sites only).
- Neurological exam free of clinically significant, unexplained signs or symptoms during screening and no clinically significant change prior to randomization
Key exclusion criteria (17 listed)
- Short bowel syndrome
- Stricture with obstructive symptoms within 3 months
- Bowel surgery within 12 weeks prior baseline, or has planned bowel surgery within 24 weeks from baseline
- Ileostomy and/or colostomy
- Any gastric or intestinal pouch
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 |
|---|---|---|
| AbrilumabAlso: AMG 181Administered by subcutaneous injection. | Drug | Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M, Abrilumab 210 mg/Abrilumab 210 mg Q3M, Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M, Placebo Q4W/Abrilumab 210 mg Q3M |
| PlaceboPlacebo matching to abrilumab administered by subcutaneous injection | Drug | Abrilumab 210 mg/Abrilumab 210 mg Q3M, Placebo Q4W/Abrilumab 210 mg Q3M |
Primary outcome
Percentage of Participants With Remission at Week 8
Time frame: Week 8
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150 at week 8. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity. The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
7 secondary outcomes
Percentage of Participants With Remission at Week 12
Time frame: Week 12
Percentage of Participants With Response at Week 12
Time frame: Baseline and week 12
Percentage of Participants With Response at Week 8
Time frame: Baseline and week 8
Percentage of Participants With Sustained Remission at Both Week 12 and Week 24
Time frame: Week 12 and week 24
Percentage of Participants With Sustained Remission at Both Week 8 and Week 24
Time frame: Week 8 and week 24
Change From Baseline in CDAI Score at Week 12
Time frame: Baseline and week 12
Change From Baseline in CDAI Score at Week 8
Time frame: Baseline and week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28238174Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
84 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abrilumab in people with Crohn's Disease, run by Amgen at 84 sites in 12 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 6 inclusion and 17 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 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States, France, Canada, Czechia, Denmark and 7 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 27 Jun 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 Remission 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 NCT01696396, which also lists 1 linked publication.
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 27 Jun 2019.