Ulcerative ColitisPhase 1NCT00295282
A Dose-Escalation Study of MDX-1100 in Patients With Active Ulcerative Colitis
A Phase 1 study testing MDX-1100 (anti-CXCL10 human monoclonal antibody) in people with Ulcerative Colitis, run by Bristol-Myers Squibb at 5 sites in United States.
Trial summary
This is a Phase I dose-escalation study of MDX-1100. patients with ulcerative colitis will be enrolled into one of four dose cohorts, to receive of MDX-1100 at 0.3, 1.0, 3.0 or 10mg/kg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- MDX-1100 (anti-CXCL10 human monoclonal antibody)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2006to Jan 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed informed consent and HIPAA
- must be 18 years or older
- patients with active ulcerative colitis with a UCDAI greater than or equal to 4 and less than or equal to 9.
- certain medications initiated at specific schedules prior to study drug administration may be enrolled.
- must meet screening laboratory values
- women of childbearing potential must be using effective contraception for at least 1 month prior to study entry and agree to continue contraception for the duration of their participation in the study, and
- Sexually active male patients must use a barrier method of contraception during the course of the study.
Who cannot join
- History of colectomy, partial colectomy, current ostomy, or pouchitis
- Presence of Cushing's Syndrome
- Toxic megacolon or fulminant disease likely to require colectomy
- Prior treatment with any monoclonal antibody or immunoglobulin-based fusion proteins 8 weeks or less prior to treatment with MDX-1100
- Any experimental treatment 4 weeks or less prior to treatment with MDX-1100
- Primary or secondary immunodeficiency
Show all 22Show fewer
- Any history of malignancy, excluding adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ
- Active major psychiatric disease(stable depression receiving appropriate medical management will be permitted)
- Evidence of acute or chronic infection or neoplasm on Screening chest radiography
- Current treatment for TB or positive PPD without prophylaxis
- Herpes zoster 3 months or less prior to screening
- Clinically significant cardiac disease requiring medication, unstable angina, myocardial infarction within 6 months, or congestive heart failure
- Active infectious disease requiring i.v. antibiotics within the past 4 weeks or oral antibiotics at the time of enrollment
- Arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities
- History of cerebrovascular disease requiring medication/treatment
- Anticoagulation therapy or a known bleeding disorder
- Seizure disorder requiring active therapy
- Known drug or alcohol abuse
- Positive tests for HIV, HBV, or HCV
- Pregnant or nursing
- Any underlying medical condition that in the Investigator's opinion will make the administration of study drug hazardous to the patient or would obscure the interpretation of adverse events, or
- Inability or unwillingness to return for Follow-up visits
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Metropolitan Gastroenterology Group, PC
Chevy Chase, Maryland, 20815
DMI Health Care Group, Inc.
Largo, Florida, 33773
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Medicine and Dentistry of New Jersery (UMDNJ)
New Brunswick, New Jersey, 08903
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: A Phase I, Multicenter, Dose-escalation Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Patients With Active Ulcerative Colitis
This is a Phase I dose-escalation study of MDX-1100. patients with ulcerative colitis will be enrolled into one of four dose cohorts, to receive of MDX-1100 at 0.3, 1.0, 3.0 or 10mg/kg. Three to six patients will be enrolled at each dose level, starting at the lowest dose level, for a maximum of 24 patients to be enrolled into the study. The study is designed to establish the safety and tolerability of single doses of MDX-1100 administered in dose-escalating cohorts to patients with ulcerative colitis. Other study objectives include characterizing a pharmacokinetic profile and pharmacodynamic effects of MDX-1100 and determination of immunogenic response to MDX-1100.
Read the detailed description
The primary objectives of this study is to establish the safety and tolerability of single doses of MDX-1100 administered in dose-escalating cohorts to patients with active ulcerative colitis (UC).
The secondary objectives include:
- to characterize the pharmacokinetic profile of MDX-1100,
- to determine the pharmacodynamic effects of MDX-1100 on CXCL10-related surrogate markers,
- to obtain preliminary evidence as assessed by the Ulcerative Colitis Disease Activity Index (DAI),
- to determine the immunogenic response to MDX-1100, and
- determine the safety and efficacy of repeat doses in patients who respond to a single dose of MDX-1100.
This is a Phase I, multicenter, dose-escalation study of MDX-1100 (anti-CXCL10 human monoclonal antibody) in patients with UC, as defined by standard clinical, endoscopic and histological criteria and a DAI greater than or equal to 4 and less than or equal to 9. Three to six patients will be entered into each of 4 cohorts (0.3, 1.0, 3.0 or 10mg/kg). Starting with the lowest dose cohort (0.3mg/kg), patients will be administered a single dose of MDX-1100 at Day 1 and will be followed until 70 days from the last dose. Dose escalation may proceed when the third patient in the cohort has reached Day 29 and if no dose-limiting toxicities (DLTs) have occurred. Dose escalation may proceed when the sixth patient reaches Day 29 and <2 DLTs have occurred in the cohort. Dose escalation will continue until the last cohort is enrolled or the maximum tolerated dose (MTD) is defined.
Patients who respond to the initial dose, as defined by a decrease in the UC disease activity index (UCDAI) by greater than or equal to 3 points at Day 29 compared to baseline, will be offered the option of receiving up to 3 additional doses of MDX-1100 at their originally assigned dose level. Re-dosing will be permitted at the time of disease flare which is defined as a worsening of the modified UCDAI of greater than or equal to 2 compared to the prior nadir. In order to obtain PK data, the first re-dose may not be administered until Day 43 and all subsequent doses may be great than or equal to 28 days apart. A response in the repeat dosing phase will be defined as a decrease in the mUCDAI of greater than or equal to 2 as compared to the previous baseline mUCDAI. For the second infusion, the comparison will use the mUCDAI calculated at Day 29 or subsequent nadir.
The study will terminate approximately 70 days after the last patient has received the last dose of MDX-1100. It is anticipated that the maximum total time on study for any patient will be less than 1 year.
- Conditions
- Ulcerative Colitis
- Being tested
- MDX-1100 (anti-CXCL10 human monoclonal antibody)
- Keywords
- Ulcerative Colitis, UC, Colitis
- Medical subject headings
- Colitis, Ulcerative, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDX-1100 (anti-CXCL10 human monoclonal antibody)Drug
Patients will receive a single dose of MDX-1100 at 0.3, 1.0, 3.0 or 10 mg/kg as a 60 minute intravenous infusion. Patients who respond to treatment may receive up to an additional 3 doses of MDX-1100.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients will receive active MDX-1100 Receives: Drug: MDX-1100 (anti-CXCL10 human monoclonal antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of treatment-emergent adverse events
Measured: events will be followed to resolution
Secondary outcomes (6)
vital sign measurements
Measured: study duration - each visit
clinical laboratory tests
Measured: study duration - each visit
immunogenicity assessment
Measured: dosing and follow up phases
physical examinations
Measured: study duration - each visit
Electrocardiograph
Measured: periodically through study duration
pharmacokinetic sampling
Measured: during dosing phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295282
- Sponsor's protocol ID
- MDX1100-01
- Other IDs
- IM129-001
- Status last verified
- Apr 2010
- First submitted
- 21 Feb 2006
- Last updated
- 23 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Dose-escalation Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Patients With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00295282
- Acronym / sponsor ID
- MDX1100-01
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, UC, Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 23 Feb 2006 (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.
This is a Phase I dose-escalation study of MDX-1100. patients with ulcerative colitis will be enrolled into one of four dose cohorts, to receive of MDX-1100 at 0.3, 1.0, 3.0 or 10mg/kg. Three to six patients will be enrolled at each dose level, starting at the lowest dose level, for a maximum of 24 patients to be enrolled into the study. The study is designed to establish the safety and tolerability of single doses of MDX-1100 administered in dose-escalating cohorts to patients with ulcerative colitis. Other study objectives include characterizing a pharmacokinetic profile and pharmacodynamic effects of MDX-1100 and determination of immunogenic response to MDX-1100.
Detailed description
The primary objectives of this study is to establish the safety and tolerability of single doses of MDX-1100 administered in dose-escalating cohorts to patients with active ulcerative colitis (UC).
The secondary objectives include:
- to characterize the pharmacokinetic profile of MDX-1100,
- to determine the pharmacodynamic effects of MDX-1100 on CXCL10-related surrogate markers,
- to obtain preliminary evidence as assessed by the Ulcerative Colitis Disease Activity Index (DAI),
- to determine the immunogenic response to MDX-1100, and
- determine the safety and efficacy of repeat doses in patients who respond to a single dose of MDX-1100.
This is a Phase I, multicenter, dose-escalation study of MDX-1100 (anti-CXCL10 human monoclonal antibody) in patients with UC, as defined by standard clinical, endoscopic and histological criteria and a DAI greater than or equal to 4 and less than or equal to 9. Three to six patients will be entered into each of 4 cohorts (0.3, 1.0, 3.0 or 10mg/kg). Starting with the lowest dose cohort (0.3mg/kg), patients will be administered a single dose of MDX-1100 at Day 1 and will be followed until 70 days from the last dose. Dose escalation may proceed when the third patient in the cohort has reached Day 29 and if no dose-limiting toxicities (DLTs) have occurred. Dose escalation may proceed when the sixth patient reaches Day 29 and <2 DLTs have occurred in the cohort. Dose escalation will continue until the last cohort is enrolled or the maximum tolerated dose (MTD) is defined.
Patients who respond to the initial dose, as defined by a decrease in the UC disease activity index (UCDAI) by greater than or equal to 3 points at Day 29 compared to baseline, will be offered the option of receiving up to 3 additional doses of MDX-1100 at their originally assigned dose level. Re-dosing will be permitted at the time of disease flare which is defined as a worsening of the modified UCDAI of greater than or equal to 2 compared to the prior nadir. In order to obtain PK data, the first re-dose may not be administered until Day 43 and all subsequent doses may be great than or equal to 28 days apart. A response in the repeat dosing phase will be defined as a decrease in the mUCDAI of greater than or equal to 2 as compared to the previous baseline mUCDAI. For the second infusion, the comparison will use the mUCDAI calculated at Day 29 or subsequent nadir.
The study will terminate approximately 70 days after the last patient has received the last dose of MDX-1100. It is anticipated that the maximum total time on study for any patient will be less than 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MDX-1100 (anti-CXCL10 human monoclonal antibody)patients will receive active MDX-1100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- signed informed consent and HIPAA
- must be 18 years or older
- patients with active ulcerative colitis with a UCDAI greater than or equal to 4 and less than or equal to 9.
- certain medications initiated at specific schedules prior to study drug administration may be enrolled.
- must meet screening laboratory values
Key exclusion criteria (22 listed)
- History of colectomy, partial colectomy, current ostomy, or pouchitis
- Presence of Cushing's Syndrome
- Toxic megacolon or fulminant disease likely to require colectomy
- Prior treatment with any monoclonal antibody or immunoglobulin-based fusion proteins 8 weeks or less prior to treatment with MDX-1100
- Any experimental treatment 4 weeks or less prior to treatment with MDX-1100
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 |
|---|---|---|
| MDX-1100 (anti-CXCL10 human monoclonal antibody)Patients will receive a single dose of MDX-1100 at 0.3, 1.0, 3.0 or 10 mg/kg as a 60 minute intravenous infusion. Patients who respond to treatment may receive up to an additional 3 doses of MDX-1100. | Drug | 1 |
Primary outcome
incidence and severity of treatment-emergent adverse events
Time frame: events will be followed to resolution
6 secondary outcomes
vital sign measurements
Time frame: study duration - each visit
clinical laboratory tests
Time frame: study duration - each visit
immunogenicity assessment
Time frame: dosing and follow up phases
physical examinations
Time frame: study duration - each visit
Electrocardiograph
Time frame: periodically through study duration
pharmacokinetic sampling
Time frame: during dosing phase
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 23 Apr 2010.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MDX-1100 (anti-CXCL10 human monoclonal antibody) in people with Ulcerative Colitis, run by Bristol-Myers Squibb at 5 sites in United States.
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 22 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 23 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
incidence and severity of treatment-emergent adverse events (time frame: events will be followed to resolution). 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 23 Apr 2010.