Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis

A Phase 2 study testing Abrilumab in people with Ulcerative Colitis, run by Amgen at 123 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore > 1 point. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Ulcerative Colitis
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: 359 participants
Where: 123 sitesin 20 countries
Study dates: 16 Nov 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

Diagnosis of ulcerative colitis (UC) established ≥ 3 months before baseline by clinical and endoscopic evidence and corroborated by a histopathology report.
Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with a centrally read rectosigmoidoscopy score ≥2 prior to baseline
Inadequate response to, loss of response to, or intolerance to at least one of the following treatments:
Immunomodulators
Anti-TNF agents
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

Who cannot join

Disease limited to the rectum (ie, within 10 cm of the anal verge)
Toxic megacolon
Crohn's Disease
History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC
Planned bowel surgery within 24 weeks from baseline
Stool positive for C. Difficile toxin at screening

Show all 25Show fewer

History of gastrointestinal surgery within 8 weeks of baseline
Primary Sclerosing Cholangitis
Any uncontrolled or clinically significant systemic disease
Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion.
Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus antibody or human immunodeficiency virus (HIV)
Underlying condition that predisposes subject to infections (eg, uncontrolled diabetes; history of splenectomy)
Known history of drug or alcohol abuse within 1 year of screening
Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease free state since treatment)
Immunosuppressive therapy with either cyclosporine A, tacrolimus, or mycophenolate mofetil, within 1 month prior to baseline
Prior exposure to anti tumor necrosis factor (TNF) agents, within 2 months, or 5 times the respective elimination half life (whichever is longer) prior to baseline
Any prior exposure to vedolizumab, rituximab, efalizumab, natalizumab
Use of topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids within 2 weeks prior to baseline
Use of intravenous or intramuscular corticosteroids within 2 weeks prior to screening and during screening
Previously treated with AMG 181
Received any type of live attenuated vaccine < 1 month prior to baseline or is planning to receive any such live attenuated vaccine over the course of the study
Treatment of infection with intravenous (within 30 days of baseline) or oral (within 14 days prior to baseline) antibiotics, antivirals, or antifungals
Abnormal laboratory results at screening
Any other laboratory abnormality, which, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)

Trial locations and contacts

123 sites in 20 countries.

Country

City, postcode or hospital

123 sites in 20 countries

United States25 sites

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
Great Neck, New York, 11021
Research Site
Greenville, North Carolina, 27834
Research Site
Hammond, Louisiana, 70403
Research Site
Jacksonville, Florida, 32256
Research Site
La Jolla, California, 92093
Research Site
Lone Tree, Colorado, 80124
Research Site
Mentor, Ohio, 44060
Research Site
Miami, Florida, 33136
Research Site
Mobile, Alabama, 36608
Research Site
Naples, Florida, 34102
Research Site
New York, New York, 10029
Research Site
Rochester, Minnesota, 55905
Research Site
San Antonio, Texas, 78229
Research Site
Scottsdale, Arizona, 85260
Research Site
Seattle, Washington, 98101
Research Site
Seattle, Washington, 98185
Research Site
Torrance, California, 90505
Research Site
Urbana, Illinois, 61801

Other trials in United States

Hungary9 sites

Research Site
Békéscsaba, 5600
Research Site
Budapest, 1088
Research Site
Budapest, 1125
Research Site
Debrecen, 4032
Research Site
Miskolc, 3526
Research Site
Miskolc, 3529
Research Site
Pécs, 7624
Research Site
Szeged, 6725
Research Site
Szekszárd, 7100

Other trials in Hungary

France8 sites

Research Site
Amiens, 80054
Research Site
Caen, 14000
Research Site
Lille, 59037
Research Site
Nice, 06202
Research Site
Paris, 75571
Research Site
Pessac, 33604
Research Site
Toulouse, 31059
Research Site
Vandœuvre-lès-Nancy, 54511

Other trials in France

Canada7 sites

Research Site
Calgary, Alberta, T2N 4N1
Research Site
Kingston, Ontario, K7L 5G2
Research Site
London, Ontario, N6A 5A5
Research Site
Toronto, Ontario, M5G 1X5
Research Site
Vancouver, British Columbia, V5Z 1M9
Research Site
Vancouver, British Columbia, V6Z 2K5
Research Site
Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

United Kingdom7 sites

Research Site
Birmingham, B15 2TH
Research Site
Blackpool, FY3 8NR
Research Site
Coventry, CV2 2DX
Research Site
Derby, DE22 3NE
Research Site
London, NW3 2QG
Research Site
Manchester, M13 9WL
Research Site
Norwich, NR4 7UY

Other trials in United Kingdom

Belgium6 sites

Research Site
Bonheiden, 2820
Research Site
Brussels, 1000
Research Site
Brussels, 1200
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
Liège, 4000

Other trials in Belgium

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

Other trials in Denmark

Germany6 sites

Research Site
Berlin, 13353
Research Site
Berlin, 14050
Research Site
Frankfurt am Main, 60431
Research Site
Halle, 06120
Research Site
Heidelberg, 69120
Research Site
Kiel, 24105

Other trials in Germany

Italy6 sites

Research Site
Bologna, 40138
Research Site
Florence, 50134
Research Site
Milan, 20157
Research Site
Padova, 35128
Research Site
Roma, 00152
Research Site
Rozzano MI, 20089

Other trials in Italy

Poland6 sites

Research Site
Bialystok, 15-950
Research Site
Bydgoszcz, 85-079
Research Site
Lodz, 90-153
Research Site
Lodz, 90-242
Research Site
Lodz, 90-302
Research Site
Warsaw, 03-580

Other trials in Poland

Russia6 sites

Research Site
Moscow, 123423
Research Site
Nizhny Novgorod, 603126
Research Site
Saint Petersburg, 191015
Research Site
Samara, 443063
Research Site
St.-Petrsburg, 196247
Research Site
Stavropol, 355017

Other trials in Russia

Greece5 sites

Research Site
Athens, 10676
Research Site
Haidari, 12462
Research Site
Heraklion, 71110
Research Site
Larissa, 41110
Research Site
Piraeus, 18454

Other trials in Greece

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

Other trials in Netherlands

Australia4 sites

Research Site
Adelaide, South Australia, 5000
Research Site
Bankstown, New South Wales, 2200
Research Site
Box Hill, Victoria, 3128
Research Site
Concord, New South Wales, 2139

Other trials in Australia

Czechia4 sites

Research Site
Hradec Králové, 500 12
Research Site
Prague, 140 59
Research Site
Prague, 170 04
Research Site
Ústí nad Labem, 401 13

Other trials in Czechia

Austria3 sites

Research Site
Innsbruck, 6020
Research Site
Sankt Veit an der Glan, 9300
Research Site
Vienna, 1090

Other trials in Austria

Estonia3 sites

Research Site
Tallinn, 10117
Research Site
Tallinn, 10138
Research Site
Tartu, 51014

Other trials in Estonia

Switzerland3 sites

Research Site
Basel, 4031
Research Site
Bern, 3010
Research Site
Zurich, 8091

Other trials in Switzerland

Latvia2 sites

Research Site
Riga, 1002
Research Site
Riga, LV-1005

Other trials in Latvia

Norway2 sites

Research Site
Oslo, 0450
Research Site
Tromsø, 9038

Other trials in Norway

About this study

Official title: A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis

Read the detailed description

The study consisted of a 24-week double-blind, placebo-controlled treatment period followed by an open-label period of approximately 108 weeks. Participants were eligible to enter the open-label period of the study early if they did not achieve a response at week 8 and had an inadequate response at week 12 or later or if they experienced disease worsening after achieving response and/or remission at week 8. Failure to achieve response at week 8 was defined as failure to achieve a decrease from baseline in total Mayo Score ≥ 3 points and ≥ 30% decrease from baseline. Inadequate response at week 12 or later was defined as failure to achieve a 2-point decrease and 25% improvement in partial Mayo Score compared with screening and minimum partial Mayo Score ≥ 5 points. Disease worsening was defined as an increase in partial Mayo Score ≥ 3 points from the week 8 value and minimum partial Mayo Score ≥ 5 points with recto-sigmoidoscopy sub-score ≥ 2.

Participants were planned to be randomized in a 2:1:2:2:2 ratio to placebo or abrilumab at 7 mg, 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 4:3:2. 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: Ulcerative Colitis
Being tested: Abrilumab, Placebo
Keywords: Ulcerative Colitis, IBD
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AbrilumabBiological
Also called AMG 181
Administered by subcutaneous injection.
PlaceboDrug
Placebo matching to abrilumab administered by subcutaneous injection

Study groups in NCT01694485
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: Biological: Abrilumab; Drug: Placebo
Abrilumab 7 mg Q4W/Abrilumab 210 mg Q3M	Experimental	Participants received 7 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: Biological: Abrilumab
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 thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks. Receives: Biological: 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: Biological: 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: Biological: 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 total Mayo Score ≤ 2 points, with no individual subscore > 1 point.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.
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 total Mayo Score (adjusted remission rate).
Measured: Week 8

Secondary outcomes (3)

Percentage of Participants With Response at Week 8
Response was defined by a decrease from baseline in the total Mayo Score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore ≥ 1 point or an absolute rectal bleeding subscore = 0 or 1.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, ranging from 0 to 12 points. Higher scores represent more severe disease.
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 total Mayo Score (adjusted response rate).
Measured: Baseline and week 8
Percentage of Participants With Mucosal Healing at Week 8
Mucosal healing was defined using the rectosigmoidoscopy subscore of Mayo assessment as absolute subscore for rectosigmoidoscopy of 0 or 1.
Flexible rectosigmoidoscopy was performed as part of the Mayo assessment, graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status.
The healing rate (percentage of participants with mucosal healing) was calculated based on observed data (unadjusted healing 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 rectosigmoidoscopy score (adjusted healing rate).
Measured: Week 8
Percentage of Participants With Sustained Remission at Week 8 and Week 24
Remission was defined as a total Mayo Score ≤ 2 points, with no individual subscore > 1 point. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher scores represent more severe disease status. The total Mayo Score is the sum of the four item scores, with a and ranges from 0 to 12 points. Higher scores represent more severe disease.
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 total Mayo Score (adjusted remission rate).
Measured: Week 8 and week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 201210 Apr 2018

First posted27 Sep 2012 (estimated)
Study start16 Nov 2012
Primary completion13 Jul 2015
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 Ulcerative ColitisStudies 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: 359 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01694485
Sponsor's protocol ID: 20110166
Other IDs: 2011-005251-13
Status last verified: May 2019
First submitted: 24 Sep 2012
Last updated: 27 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Sandborn WJ, Cyrille M, Hansen MB, Feagan BG, Loftus EV Jr, Rogler G, Vermeire S, Cruz ML, Yang J, Boedigheimer MJ, Abuqayyas L, Evangelista CM, Sullivan BA, Reinisch W. Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2019 Mar;156(4):946-957.e18. doi: 10.1053/j.gastro.2018.11.035. Epub 2018 Nov 23.
PubMed 30472236

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

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, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis
ClinicalTrials.gov ID: NCT01694485
Acronym / sponsor ID: 20110166
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis, IBD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 359 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 16 Nov 2012 (actual)
Primary completion: 13 Jul 2015 (actual)
Study completion: 10 Apr 2018 (actual)
First posted: 27 Sep 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Placebo Q4W/Abrilumab 210 mg Q3M	Placebo comparator	Biological: 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 7 mg Q4W/Abrilumab 210 mg Q3M	Experimental	Biological: AbrilumabParticipants received 7 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 21 mg Q4W/Abrilumab 210 mg Q3M	Experimental	Biological: AbrilumabParticipants received 21 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 70 mg Q4W/Abrilumab 210 mg Q3M	Experimental	Biological: 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	Biological: 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 (7 listed)

Diagnosis of ulcerative colitis (UC) established ≥ 3 months before baseline by clinical and endoscopic evidence and corroborated by a histopathology report.
Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with a centrally read rectosigmoidoscopy score ≥2 prior to baseline
Inadequate response to, loss of response to, or intolerance to at least one of the following treatments:
Neurological exam free of clinically significant, unexplained signs or symptoms during screening and no clinically significant change prior to randomization

Key exclusion criteria (25 listed)

Disease limited to the rectum (ie, within 10 cm of the anal verge)
Toxic megacolon
Crohn's Disease
History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC
Planned bowel surgery within 24 weeks from baseline

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.	Biological	Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M, Abrilumab 210 mg/Abrilumab 210 mg Q3M, Abrilumab 7 mg Q4W/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 total Mayo Score ≤ 2 points, with no individual subscore > 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. 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 total Mayo Score (adjusted remission rate).

3 secondary outcomes

Percentage of Participants With Response at Week 8
Time frame: Baseline and week 8
Percentage of Participants With Mucosal Healing at Week 8
Time frame: Week 8
Percentage of Participants With Sustained Remission at Week 8 and Week 24
Time frame: Week 8 and week 24

Results and safety

Results posted to the registry on 27 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo/Abrilumab 210 mg Q3M	117	84
Abrilumab 7 mg Q4W/Abrilumab 210 mg Q3M	22	15
Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M	40	27
Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M	100	62
Abrilumab 210 mg/Abrilumab 210 mg Q3M	80	55

Primary outcome: Percentage of Participants With Remission at Week 8

Time frame: Week 8. Number. Unit: percentage of participants

Measure	Placebo n = 116	Abrilumab 7 mg Q4W n = 21	Abrilumab 21 mg Q4W n = 40	Abrilumab 70 mg Q4W n = 98	Abrilumab 210 mg n = 79
Unadjusted remission rate	4.3	0.0	2.5	13.3	12.7
Adjusted remission rate	4.4	1.6	2.9	13.5	13.4

Placebo vs Abrilumab 70 mg Q4W: Odds Ratio (OR): 3.35 (90% CI 1.41 to 7.95), p = 0.021, Regression, Logistic
Placebo vs Abrilumab 70 mg Q4W: Difference in Adjusted Remission Rates: 9.0 (90% CI 1.6 to 14.6)
Placebo vs Abrilumab 210 mg: Odds Ratio (OR): 3.33 (90% CI 1.34 to 8.26), p = 0.030, Regression, Logistic

Population analysed: The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted remission rates were calculated using non-responder imputation, where participants with a missing Mayo Score at week 8 were counted as non-responders.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DB Period: Placebo	14 of 116 (12.1%)	47 of 116 (40.5%)	Not reported
DB Period: Abrilumab 7 mg Q4W	1 of 20 (5%)	9 of 20 (45%)	Not reported
DB Period: Abrilumab 21 mg Q4W	3 of 40 (7.5%)	16 of 40 (40%)	Not reported
DB Period: Abrilumab 70 mg Q4W	5 of 99 (5.1%)	55 of 99 (55.6%)	Not reported
DB Period: Abrilumab 210 mg	7 of 79 (8.9%)	35 of 79 (44.3%)	Not reported
OL Period: Placebo/Abrilumab 210 mg Q3M	13 of 100 (13%)	55 of 100 (55%)	Not reported
OL Period: Abrilumab 7 mg Q4W/210 mg Q3M	3 of 18 (16.7%)	10 of 18 (55.6%)	Not reported
OL Period: Abrilumab 21 mg Q4W/210 mg Q3M	4 of 36 (11.1%)	19 of 36 (52.8%)	Not reported
OL Period: Abrilumab 70 mg Q4W/210 mg Q3M	14 of 89 (15.7%)	53 of 89 (59.6%)	Not reported
OL Period: Abrilumab 210 mg/210 mg Q3M	6 of 68 (8.8%)	26 of 68 (38.2%)	Not reported

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.
Derived from this study: PubMed 30472236Sandborn WJ, Cyrille M, Hansen MB, Feagan BG, Loftus EV Jr, Rogler G, Vermeire S, Cruz ML, Yang J, Boedigheimer MJ, Abuqayyas L, Evangelista CM, Sullivan BA, Reinisch W. Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2019 Mar;156(4):946-957.e18. doi: 10.1053/j.gastro.2018.11.035. Epub 2018 Nov 23.
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

123 sites in 20 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 Ulcerative Colitis, run by Amgen at 123 sites in 20 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 7 inclusion and 25 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 123 sites in United States, Hungary, France, Canada, United Kingdom and 15 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 NCT01694485, 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.