Crohn's DiseasePhase 2NCT01150890
Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease
A Phase 2 study testing Brodalumab in people with Crohn's Disease, run by Amgen at 50 sites in 8 countries.
Trial summary
The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is… 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?
- Brodalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 50 sitesin 8 countries
- Study dates
- 9 Nov 2010to 15 Oct 2011
- 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 initiating study drug
- Moderately to severely active Crohn's disease, as defined by a CDAI score >250 and < 450 at baseline
- Evidence of active inflammation
Who cannot join
- Short bowel syndrome
- Stricture with obstructive symptoms within 3 months
- Bowel surgery within 3 months
- Ileostomy and/or colostomy
- Any gastric or intestinal pouch
- Ulcerative colitis
Show all 19Show fewer
- Evidence of an infected abscess
- Bowel perforation or evidence of noninflammatory obstruction during the 6 months
- Stool positive for C. Difficile toxin at screening
- Presence of active infection requiring treatment
- Serious infection within 8 weeks
- Significant concurrent medical conditions
- Pregnant or breast feeding
- Significant Laboratory abnormalities
- Any anti-tumor necrosis factor (TNF) agent within 2 months
- Steroid enemas within 2 weeks
- Tysabri (natalizumab) within 1 year
- Biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 3 months
- Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus within 2 months
Trial locations and contacts
50 sites in 8 countries.
50 sites in 8 countries
United States18 sites
Research Site
Birmingham, Alabama
Research Site
Charlotte, North Carolina
Research Site
Chevy Chase, Maryland
Research Site
Dothan, Alabama
Research Site
Egg Harbor, New Jersey
Research Site
Germantown, Tennessee
Research Site
Great Neck, New York
Research Site
Hammond, Louisiana
Research Site
Jacksonville, Florida
Research Site
Logan, Utah
Research Site
Lowell, Arkansas
Research Site
Mexico, Missouri
Research Site
Miami, Florida
Research Site
Nashville, Tennessee
Research Site
Ogden, Utah
Research Site
Rochester, Minnesota
Research Site
San Antonio, Texas
Research Site
Wilmington, North Carolina
Canada8 sites
Research Site
Calgary, Alberta
Research Site
Hamilton, Ontario
Research Site
London, Ontario
Research Site
Montreal, Quebec
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
Research Site
Victoria, British Columbia
Research Site
Winnipeg, Manitoba
France5 sites
Research Site
Lille
Research Site
Nice
Research Site
Paris
Research Site
Toulouse
Research Site
Vandœuvre-lès-Nancy
Australia4 sites
Research Site
Box Hill
Research Site
Fitzroy
Research Site
Fremantle
Research Site
Kurralta Park, South Australia
Belgium4 sites
Research Site
Bonheiden
Research Site
Ghent
Research Site
Leuven
Research Site
Roeselare
Poland4 sites
Research Site
Bydgoszcz
Research Site
Olsztyn
Research Site
Opole
Research Site
Sopot
Spain4 sites
Research Site
Barcelona
Research Site
Madrid
Research Site
Pontevedra, Galicia
Research Site
Santiago de Compostela, Galicia
Netherlands3 sites
Research Site
Amsterdam
Research Site
Maastricht
Research Site
Rotterdam
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn's Disease
The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.
- Conditions
- Crohn's Disease
- Being tested
- Brodalumab, Placebo
- Keywords
- Ileal Crohn's Disease, Ileo-colonic Crohn's Disease, Colonic Chron'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.
BrodalumabBiological
Also called AMG 827
Administered as as an intravenous (IV) infusion over at least 30 minutes.
PlaceboDrug
Administered as as an intravenous (IV) infusion over at least 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo intravenously at baseline and week 4. Receives: Drug: Placebo |
| Brodalumab 210 mg | Experimental | Participants received 210 mg brodalumab intravenously at baseline and week 4. Receives: Biological: Brodalumab |
| Brodalumab 350 mg | Experimental | Participants received 350 mg brodalumab intravenously at baseline and week 4. Receives: Biological: Brodalumab |
| Brodalumab 700 mg | Experimental | Participants received 700 mg brodalumab intravenously at baseline and week 4. Receives: Biological: Brodalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Clinical Remission at Week 6
Clinical remission is defined by a CDAI score of ≤ 150 points. The CDAI measures the severity of active disease using 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). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
Measured: Week 6
Secondary outcomes (7)
Percentage of Participants Who Achieved a CDAI Response at Week 6
CDAI response is defined as a reduction from baseline in CDAI score of ≥ 100 points.
The CDAI measures the severity of active disease using 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). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
Measured: Week 6
Change From Baseline in CDAI at Week 6
The CDAI measures the severity of active disease using 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). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
A negative change from baseline indicates improvement.
Measured: Baseline and week 6
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. A treatment-emergent AE is an event that occurred after the initiation of study drug or was already present prior to the initiation of study drug but worsened in either intensity or frequency after the initiation of study drug.
A serious AE is an adverse event that met at least one of the following criteria:
- fatal,
- life threatening,
- required in-patient hospitalization or prolongation of existing hospitalization,
- resulted in persistent or significant disability/incapacity,
- congenital anomaly/birth defect, and/or
- other significant medical hazard.
The investigator assessed whether each AE was possibly related to the study drug.
Measured: From first dose of study drug up to week 12.
Maximum Observed Concentration (Cmax) of Brodalumab
An optional pharmacokinetic (PK) substudy was offered to participants at a subset of sites and required additional informed consent.
Serum concentrations of brodalumab were measured using a validated analytical method, enzyme-linked immusosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay was 0.0500 μg/mL.
Measured: After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85.
Time to Maximum Observed Concentration (Tmax) of Brodalumab
An optional pharmacokinetic (PK) substudy was offered to participants at a subset of sites and required additional informed consent.
Serum concentrations of brodalumab were measured using a validated analytical method, enzyme-linked immusosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay was 0.0500 μg/mL.
Measured: After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85.
Area Under the Serum Concentration Versus Time Curve, From Time Zero to the Last Measurable Concentration (AUClast) for Brodalumab
An optional pharmacokinetic (PK) substudy was offered to participants at a subset of sites and required additional informed consent.
Serum concentrations of brodalumab were measured using a validated analytical method, enzyme-linked immusosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay was 0.0500 μg/mL.
Measured: After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85.
Area Under the Serum Concentration Versus Time Curve From Time Zero to 28 Days (AUC0-28) for Brodalumab
An optional pharmacokinetic (PK) substudy was offered to participants at a subset of sites and required additional informed consent.
Serum concentrations of brodalumab were measured using a validated analytical method, enzyme-linked immusosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay was 0.0500 μg/mL.
Measured: After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, and 57.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study start9 Nov 2010
- Primary completion15 Oct 2011
- Study completion15 Oct 2011
Why it stopped: The study was terminated early based on an imbalance in worsening Crohn's disease in active treatment groups
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 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
- NCT01150890
- Sponsor's protocol ID
- 20090072
- Other IDs
- 2010-019544-39
- Status last verified
- Nov 2021
- First submitted
- 24 Jun 2010
- Last updated
- 3 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. 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 827 in Subjects With Moderate to Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT01150890
- Acronym / sponsor ID
- 20090072
- Conditions
- Crohn's Disease
- Keywords
- Ileal Crohn's Disease, Ileo-colonic Crohn's Disease, Colonic Chron's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early based on an imbalance in worsening Crohn's disease in active treatment groups
- Enrolment
- 130 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2010 (actual)
- Primary completion
- 15 Oct 2011 (actual)
- Study completion
- 15 Oct 2011 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Posted 3 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo intravenously at baseline and week 4. |
| Brodalumab 210 mg | Experimental | Biological: BrodalumabParticipants received 210 mg brodalumab intravenously at baseline and week 4. |
| Brodalumab 350 mg | Experimental | Biological: BrodalumabParticipants received 350 mg brodalumab intravenously at baseline and week 4. |
| Brodalumab 700 mg | Experimental | Biological: BrodalumabParticipants received 700 mg brodalumab intravenously at baseline and week 4. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to initiating study drug
- Moderately to severely active Crohn's disease, as defined by a CDAI score >250 and < 450 at baseline
- Evidence of active inflammation
Key exclusion criteria (19 listed)
- Short bowel syndrome
- Stricture with obstructive symptoms within 3 months
- Bowel surgery within 3 months
- 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 |
|---|---|---|
| BrodalumabAlso: AMG 827Administered as as an intravenous (IV) infusion over at least 30 minutes. | Biological | Brodalumab 210 mg, Brodalumab 350 mg, Brodalumab 700 mg |
| PlaceboAdministered as as an intravenous (IV) infusion over at least 30 minutes. | Drug | Placebo |
Primary outcome
Percentage of Participants Who Achieved Clinical Remission at Week 6
Time frame: Week 6
Clinical remission is defined by a CDAI score of ≤ 150 points. The CDAI measures the severity of active disease using 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). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
7 secondary outcomes
Percentage of Participants Who Achieved a CDAI Response at Week 6
Time frame: Week 6
Change From Baseline in CDAI at Week 6
Time frame: Baseline and week 6
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to week 12.
Maximum Observed Concentration (Cmax) of Brodalumab
Time frame: After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85.
Time to Maximum Observed Concentration (Tmax) of Brodalumab
Time frame: After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85.
Area Under the Serum Concentration Versus Time Curve, From Time Zero to the Last Measurable Concentration (AUClast) for Brodalumab
Time frame: After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85.
Area Under the Serum Concentration Versus Time Curve From Time Zero to 28 Days (AUC0-28) for Brodalumab
Time frame: After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, and 57.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
50 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brodalumab in people with Crohn's Disease, run by Amgen at 50 sites in 8 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 3 inclusion and 19 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: stopped early, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Canada, France, Australia, Belgium and 3 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 3 Jan 2022). 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 Who Achieved Clinical Remission at Week 6 (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2022.