Crohn's DiseasePhase 2NCT00655135
Phase 2 Study of the Safety and Efficacy of LDP-02 in Mildly to Moderately Active Crohn's Patients
A Phase 2 study testing LDP-02 in people with Crohn's Disease, run by Millennium Pharmaceuticals, Inc..
Trial summary
The objectives of this study were to assess the safety and tolerability of LDP-02 in patients with active Crohn's disease who were not receiving corticosteroids or immunosuppressives, to assess the ability of LDP-02 to reduce Crohn's disease activity, and to obtain pharmacokinetic (PK) and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- LDP-02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Jun 2002
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80, nonhospitalized, male or nonpregnant, nonlactating females voluntarily able to give informed consent.
- Crohn's disease of at least 6 months' duration.
- Endoscopic and/or histopathological and/or radiological documentation consistent with Crohn's disease obtained preferably within 24 months of screening.
- Crohn's disease involving the colon and/or the ileum.
- CDAI score from 220 to 400 (inclusive) at the time of the Screening visit. The CDAI must have remained between 220 and 400 after the 1-week Screening period for the patient to be eligible.
- Patients may have been receiving oral or topical 5-ASA compounds provided the dosage had been stable for at least the 14-day period before the Screening visit. Patients were to be maintained on the 5-ASA compound at a constant dose at least through Day 57.
Who cannot join
- Patients with evidence of current GI infection (bacterial or parasitic) or significant infection within 45 days of the screening visit.
- Patients with a serious underlying disease other than Crohn's disease including presence or history of malignancy (except basal cell carcinoma) and histological evidence of dysplasia.
- Patients with significantly impaired liver or renal function. This includes those with established chronic liver disease including hepatitis B or C.
- Patients with the laboratory abnormalities
- Patients using ethanol or consuming illicit drugs which, in the investigator's opinion, may interfere with compliance with the study procedures.
- Patients with active psychiatric problems which, in the investigator's opinion, may interfere with compliance with the study procedures.
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- Patients who have previously received or who are currently receiving treatment with a monoclonal antibody.
- Patients receiving any investigational therapy, excluded medications as defined in protocol, or any approved therapy in an investigational protocol within 30 days prior to screening.
- Patients unable to attend all the study visits or comply with study procedures.
About this study
Official title: Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Determine the Safety, Pharmacokinetics, and Effectiveness of LDP-02 in Patients With Mildly to Moderately Active Crohn's Disease
The objectives of this study were to assess the safety and tolerability of LDP-02 in patients with active Crohn's disease who were not receiving corticosteroids or immunosuppressives, to assess the ability of LDP-02 to reduce Crohn's disease activity, and to obtain pharmacokinetic (PK) and pharmacodynamic(PD)information for LDP-02 in patients with active Crohn's disease.
- Conditions
- Crohn's Disease
- Being tested
- LDP-02, Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDP-02Drug
Also called MLN0002, MLN02
Each patient in arms 2 \& 3 received a single IV dose of study drug at 0.5 or 2.0 mg/kg LDP-02 on Days 1 and 29.
PlaceboDrug
Also called MLN0002, MLN02
Each patients in arm 1 received a single IV dose of placebo on Days 1 and 29.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Patients were assigned to arms in a 1:1:1 ratio. Patients in this arm received placebo administered intravenously to patients on Day 1 and Day 29. Receives: Drug: Placebo |
| 2 | Experimental | Patients were assigned to arms in a 1:1:1 ratio. Patients in this arm received 0.5 mg/kg of LDP-02 administered intravenously to patients on Day 1 and Day 29. Receives: Drug: LDP-02 |
| 3 | Experimental | Patients were assigned to arms in a 1:1:1 ratio. Patients in this arm received 2 mg/kg of LDP-02 administered intravenously to patients on Day 1 and Day 29. Receives: Drug: LDP-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure was the proportion of patients with a clinical response, defined as a reduction from baseline in the CDAI score of at least 70 points at Day 57
Measured: Days 1-57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startFeb 2000
- Primary completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655135
- Sponsor's protocol ID
- L299-016
- Status last verified
- Apr 2008
- First submitted
- 3 Apr 2008
- Last updated
- 9 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Feagan BG, Greenberg GR, Wild G, Fedorak RN, Pare P, McDonald JW, Cohen A, Bitton A, Baker J, Dube R, Landau SB, Vandervoort MK, Parikh A. Treatment of active Crohn's disease with MLN0002, a humanized antibody to the alpha4beta7 integrin. Clin Gastroenterol Hepatol. 2008 Dec;6(12):1370-7. doi: 10.1016/j.cgh.2008.06.007. Epub 2008 Oct 1.
PubMed 18829392
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Determine the Safety, Pharmacokinetics, and Effectiveness of LDP-02 in Patients With Mildly to Moderately Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT00655135
- Acronym / sponsor ID
- L299-016
- Conditions
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2000
- Primary completion
- Jun 2002 (actual)
- First posted
- 9 Apr 2008 (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 objectives of this study were to assess the safety and tolerability of LDP-02 in patients with active Crohn's disease who were not receiving corticosteroids or immunosuppressives, to assess the ability of LDP-02 to reduce Crohn's disease activity, and to obtain pharmacokinetic (PK) and pharmacodynamic(PD)information for LDP-02 in patients with active Crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPatients were assigned to arms in a 1:1:1 ratio. Patients in this arm received placebo administered intravenously to patients on Day 1 and Day 29. |
| 2 | Experimental | Drug: LDP-02Patients were assigned to arms in a 1:1:1 ratio. Patients in this arm received 0.5 mg/kg of LDP-02 administered intravenously to patients on Day 1 and Day 29. |
| 3 | Experimental | Drug: LDP-02Patients were assigned to arms in a 1:1:1 ratio. Patients in this arm received 2 mg/kg of LDP-02 administered intravenously to patients on Day 1 and Day 29. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 80, nonhospitalized, male or nonpregnant, nonlactating females voluntarily able to give informed consent.
- Crohn's disease of at least 6 months' duration.
- Endoscopic and/or histopathological and/or radiological documentation consistent with Crohn's disease obtained preferably within 24 months of screening.
- Crohn's disease involving the colon and/or the ileum.
- CDAI score from 220 to 400 (inclusive) at the time of the Screening visit. The CDAI must have remained between 220 and 400 after the 1-week Screening period for the patient to be eligible.
Key exclusion criteria (9 listed)
- Patients with evidence of current GI infection (bacterial or parasitic) or significant infection within 45 days of the screening visit.
- Patients with a serious underlying disease other than Crohn's disease including presence or history of malignancy (except basal cell carcinoma) and histological evidence of dysplasia.
- Patients with significantly impaired liver or renal function. This includes those with established chronic liver disease including hepatitis B or C.
- Patients with the laboratory abnormalities
- Patients using ethanol or consuming illicit drugs which, in the investigator's opinion, may interfere with compliance with the study procedures.
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 |
|---|---|---|
| LDP-02Also: MLN0002, MLN02Each patient in arms 2 \& 3 received a single IV dose of study drug at 0.5 or 2.0 mg/kg LDP-02 on Days 1 and 29. | Drug | 2, 3 |
| PlaceboAlso: MLN0002, MLN02Each patients in arm 1 received a single IV dose of placebo on Days 1 and 29. | Drug | 1 |
Primary outcome
The primary outcome measure was the proportion of patients with a clinical response, defined as a reduction from baseline in the CDAI score of at least 70 points at Day 57
Time frame: Days 1-57
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 9 Apr 2008.
- Derived from this study: PubMed 18829392Feagan BG, Greenberg GR, Wild G, Fedorak RN, Pare P, McDonald JW, Cohen A, Bitton A, Baker J, Dube R, Landau SB, Vandervoort MK, Parikh A. Treatment of active Crohn's disease with MLN0002, a humanized antibody to the alpha4beta7 integrin. Clin Gastroenterol Hepatol. 2008 Dec;6(12):1370-7. doi: 10.1016/j.cgh.2008.06.007. Epub 2008 Oct 1.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LDP-02 in people with Crohn's Disease, run by Millennium Pharmaceuticals, Inc..
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 9 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 9 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The primary outcome measure was the proportion of patients with a clinical response, defined as a reduction from baseline in the CDAI score of at least 70 points at Day 57 (time frame: Days 1-57). 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 NCT00655135, 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 9 Apr 2008.