Crohn's DiseasePhase 1NCT01258205
Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
A Phase 1 study testing AMG 139 in people with Crohn's Disease, run by AstraZeneca at 7 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- AMG 139
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 28 Feb 2011to 18 Feb 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part A - Healthy Subjects:
- Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age
- Body mass index (BMI) between 18 and 32 kg/m2
- Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
- Additional inclusion criteria apply
- Part B - Crohn's Subjects:
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- Male or female subjects with CD between 18 to 55 years-of-age
- Body mass index (BMI) between 18 and 32 kg/m2
- Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes evidence of mild to severe CD
- Diagnosis of ileal or ileo-colonic CD for a minimum of 6 months
- Mild to severe CD defined by a Crohn's Disease Activity Index (CDAI) score equal to or greater than 180 and equal to or less than 450
- Elevated fecal calprotectin and CRP
- Additional inclusion criteria apply
Who cannot join
- Parts A - Healthy Subjects:
- History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
- Recent or on-going infection(s)
- Underlying condition(s) that predisposes the subject to infections
- History of malignancy of any type
- Additional exclusion criteria apply
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- Part B only - Crohn's Subjects:
- History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
- Recent or on-going infection(s)
- Underlying condition(s) that predisposes the subject to infections
- History of malignancy of any type
- Additional exclusion criteria apply
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73102
Virginia Commonwealth University
Richmond, Virginia, 23291
Stony Brook University Medical Center
Stony Brook, New York, 11794
Australia3 sites
Clinical Medical and Analytical eXellence CMAX
Adelaide, South Australia, 5000
QPharm Pty Limited
Herston, Queensland, 4029
Centre for Clinical Studies (Alfred)
Prahran, Victoria, 3181
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease, and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease
The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD).
- Conditions
- Crohn's Disease
- Being tested
- AMG 139
- Keywords
- Amgen, AMG 139, 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.
AMG 139Drug
Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B).
| Study group | Role | What they receive |
|---|---|---|
| Part B | Experimental | One dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn's disease. Receives: Drug: AMG 139 |
| Part A | Experimental | Three dose levels of AMG 139 administered as a multiple doses IV or SC in healthy subjects. Receives: Drug: AMG 139 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139
Measured: 36 weeks
Secondary outcomes (1)
Characterization of the pharmacokinetic (PK) parameters (AUCtau, Cmax, tmax) for AMG 139 after multiple IV and SC dose administrations in healthy subjects and subjects with mild to severe CD
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study start28 Feb 2011
- Primary completion18 Feb 2015
- Study completion18 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258205
- Sponsor's protocol ID
- 20090519
- Status last verified
- May 2021
- First submitted
- 9 Dec 2010
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease, and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT01258205
- Acronym / sponsor ID
- 20090519
- Conditions
- Crohn's Disease
- Keywords
- Amgen, AMG 139, Crohn's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2011 (actual)
- Primary completion
- 18 Feb 2015 (actual)
- Study completion
- 18 Feb 2015 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part B | Experimental | Drug: AMG 139One dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn's disease. |
| Part A | Experimental | Drug: AMG 139Three dose levels of AMG 139 administered as a multiple doses IV or SC in healthy subjects. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age
- Body mass index (BMI) between 18 and 32 kg/m2
- Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
- Additional inclusion criteria apply
- Male or female subjects with CD between 18 to 55 years-of-age
Key exclusion criteria (12 listed)
- History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
- Recent or on-going infection(s)
- Underlying condition(s) that predisposes the subject to infections
- History of malignancy of any type
- Additional exclusion criteria apply
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 |
|---|---|---|
| AMG 139Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B). | Drug | Part A, Part B |
Primary outcome
Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139
Time frame: 36 weeks
1 secondary outcome
Characterization of the pharmacokinetic (PK) parameters (AUCtau, Cmax, tmax) for AMG 139 after multiple IV and SC dose administrations in healthy subjects and subjects with mild to severe CD
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
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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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 139 in people with Crohn's Disease, run by AstraZeneca at 7 sites in 2 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 13 inclusion and 12 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 10 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 7 sites in United States, Australia. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139 (time frame: 36 weeks). 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 10 May 2021.