Crohn's DiseasePhase 2NCT01545050
Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
A Phase 2 study testing BMS-945429 in people with Crohn's Disease, run by CSL Behring at 56 sites in 18 countries.
Trial summary
The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- BMS-945429
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 56 sitesin 18 countries
- Study dates
- Jun 2012to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed Crohn's Disease diagnosis via radiology, endoscopy or histology within prior 12 months. Diagnosed for at least 3 months
- Active Disease with Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450
- Failed conventional therapy or steroid dependent
Who cannot join
- Diagnosed/clinical findings of Ulcerative Colitis (UC), indeterminate colitis, non colonic/ileal disease
- Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal anastomosis
- History of diverticulitis, or evidence of Gastrointestinal (GI) perforations
Trial locations and contacts
56 sites in 18 countries.
56 sites in 18 countries
United States8 sites
University Of Florida
Gainesville, Florida, 32610
Gastro One
Germantown, Tennessee, 38138
University Of California, San Diego
La Jolla, California, 92093
South Denver Gastroenterology, Pc
Lone Tree, Colorado, 80124
University Of Louisville
Louisville, Kentucky, 40202
Premier Medical Group Of The Hudson Valley, Pc
Poughkeepsie, New York, 12601
Precision Research Institute, Llc
San Diego, California, 92114
Options Health Research, Llc
Tulsa, Oklahoma, 74104
Germany6 sites
Local Institution
Düsseldorf, 40237
Local Institution
Frankfurt A. M, 60431
Local Institution
Herne, 44623
Local Institution
Kiel, 24105
Local Institution
Magdeburg, 39120
Local Institution
Münster, 48155
France5 sites
Local Institution
Clermont-Ferrand, 63003
Local Institution
Lille, 59037
Local Institution
Nice, 06200
Local Institution
Pessac, 33600
Local Institution
Saint-Priest-en-Jarez, 42270
India5 sites
Local Institution
Hyderabad, Andhra Pradesh, 500082
Local Institution
Ludhiana, 141001
Local Institution
Mumbai, Maharashtra, 400020
Local Institution
Mumbai, 400 029
Local Institution
Pune, 411030
Italy5 sites
Local Institution
Florence, 50134
Local Institution
Padova, 35128
Local Institution
Roma, 00152
Local Institution
San Donato Milanese (mi), 20097
Local Institution
San Giovanni Rotondo (fg), 71013
Poland4 sites
Local Institution
Krakow, 31-864
Local Institution
Lodz, 90-302
Local Institution
Wroclaw, 50-556
Local Institution
Wroclaw, 53-114
Canada3 sites
Local Institution
Calgary, Alberta, T2N 4Z6
Local Institution
Saskatoon, Saskatchewan, S7N 0W8
Local Institution
Vancouver, British Columbia, V6Z 2K5
Hungary3 sites
Local Institution
Budapest, 1136
Local Institution
Debrecen, 4025
Local Institution
Pécs, 7623
Israel3 sites
Local Institution
Jerusalem, 91031
Local Institution
Rehovot, 76100
Local Institution
Tel Aviv, 64239
South Korea3 sites
Local Institution
Seoul, 120-752
Local Institution
Seoul, 135-710
Local Institution
Seoul, 138-736
Mexico2 sites
Local Institution
Mexico City, Mexico City, 14080
Local Institution
Monterrey, Nuevo León, 64460
Taiwan2 sites
Local Institution
Kaohsiung City, 80756
Local Institution
Taipei, 100
United Kingdom2 sites
Local Institution
Harrow, HA1 2UJ
Local Institution
Hull, Kingston Upon Hull, City of, HU3 2JZ
About this study
Official title: A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy.
- Conditions
- Crohn's Disease
- Being tested
- Placebo matching with BMS-945429, BMS-945429
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo matching with BMS-945429Biological
Injection, Intravenous (IV), 0 mg, Day One Only, One Day
Placebo matching with BMS-945429Biological
Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks
Placebo matching with BMS-945429Biological
Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day
Placebo matching with BMS-945429Biological
Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks
BMS-945429Biological
Also called Clazakizumab
Injection, Intravenous (IV), 600 mg, Day One Only, One Day
BMS-945429Biological
Also called Clazakizumab
Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day
BMS-945429Biological
Also called Clazakizumab
Injection, Intravenous (IV), 300 mg, Day One Only, One Day
BMS-945429Biological
Also called Clazakizumab
Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day
BMS-945429Biological
Also called Clazakizumab
Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks
BMS-945429Biological
Also called Clazakizumab
Injection, Intravenous (IV), 150 mg, Day One Only, One Day
BMS-945429Biological
Also called Clazakizumab
Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks
BMS-945429Biological
Also called Clazakizumab
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks
BMS-945429Biological
Also called Clazakizumab
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period
| Study group | Role | What they receive |
|---|---|---|
| Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab) | Experimental | Not described Receives: Biological: Placebo matching with BMS-945429 |
| Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg) | Experimental | Not described Receives: Biological: Placebo matching with BMS-945429; Biological: BMS-945429 |
| Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg) | Experimental | Not described Receives: Biological: Placebo matching with BMS-945429; Biological: BMS-945429 |
| Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg) | Experimental | Not described Receives: Biological: Placebo matching with BMS-945429; Biological: BMS-945429 |
| Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg) | Experimental | Not described Receives: Biological: Placebo matching with BMS-945429; Biological: BMS-945429 |
| Maintenance Cohort: Placebo matching with BMS-945429 (Clazakizumab) | Experimental | Not described Receives: Biological: Placebo matching with BMS-945429 |
| Maintenance Cohort: BMS-945429 (Clazakizumab)(100 SC mg) | Experimental | Not described Receives: Biological: BMS-945429 |
| Maintenance Cohort: BMS-945429 (Clazakizumab)(200 SC mg) | Experimental | Not described Receives: Biological: BMS-945429 |
| Open Label Cohort: BMS-945429 (Clazakizumab)(200 SC mg) | Experimental | Not described Receives: Biological: BMS-945429 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)
CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity
Measured: At 8 weeks during the Induction Period
Secondary outcomes (6)
Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI
CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity
Measured: At 8 weeks during the Induction Period
Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score
IBDQ consists of 32 questions divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.
Measured: Week 8 and Week 12
Number of Participants During the Induction Period With Anti-clazakizumab Antibodies
Measured: Up to Week 12
Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period
Measured: Week 4, Week 8
Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period
Measured: Week 0 and Week 4
Area Under the Plasma Concentration-time Curve in One Dosing Interval [AUC(TAU)] of Clazakizumab During the Induction Period
Measured: Week 0, Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: due to sponsor decision
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 CSL BehringThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545050
- Sponsor's protocol ID
- IM133-005
- Other IDs
- 2011-004763-72
- Status last verified
- Nov 2021
- First submitted
- 1 Mar 2012
- Last updated
- 3 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT01545050
- Acronym / sponsor ID
- IM133-005
- Conditions
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to sponsor decision
- Enrolment
- 72 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Posted 3 Dec 2021
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 characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab) | Experimental | Biological: Placebo matching with BMS-945429 |
| Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg) | Experimental | Biological: Placebo matching with BMS-945429, Biological: BMS-945429 |
| Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg) | Experimental | Biological: Placebo matching with BMS-945429, Biological: BMS-945429 |
| Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg) | Experimental | Biological: Placebo matching with BMS-945429, Biological: BMS-945429 |
| Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg) | Experimental | Biological: Placebo matching with BMS-945429, Biological: BMS-945429 |
| Maintenance Cohort: Placebo matching with BMS-945429 (Clazakizumab) | Experimental | Biological: Placebo matching with BMS-945429 |
| Maintenance Cohort: BMS-945429 (Clazakizumab)(100 SC mg) | Experimental | Biological: BMS-945429 |
| Maintenance Cohort: BMS-945429 (Clazakizumab)(200 SC mg) | Experimental | Biological: BMS-945429 |
| Open Label Cohort: BMS-945429 (Clazakizumab)(200 SC mg) | Experimental | Biological: BMS-945429 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed Crohn's Disease diagnosis via radiology, endoscopy or histology within prior 12 months. Diagnosed for at least 3 months
- Active Disease with Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450
- Failed conventional therapy or steroid dependent
Key exclusion criteria (3 listed)
- Diagnosed/clinical findings of Ulcerative Colitis (UC), indeterminate colitis, non colonic/ileal disease
- Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal anastomosis
- History of diverticulitis, or evidence of Gastrointestinal (GI) perforations
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 |
|---|---|---|
| Placebo matching with BMS-945429Injection, Intravenous (IV), 0 mg, Day One Only, One Day | Biological | Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg), Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab) |
| Placebo matching with BMS-945429Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks | Biological | Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab) |
| Placebo matching with BMS-945429Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day | Biological | Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg), Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg), Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg) |
| Placebo matching with BMS-945429Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks | Biological | Maintenance Cohort: Placebo matching with BMS-945429 (Clazakizumab) |
| BMS-945429Also: ClazakizumabInjection, Intravenous (IV), 600 mg, Day One Only, One Day | Biological | Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg) |
| BMS-945429Also: ClazakizumabInjection, Subcutaneous (SC), 200 mg, Week 8 only, One Day | Biological | Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg), Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg) |
| BMS-945429Also: ClazakizumabInjection, Intravenous (IV), 300 mg, Day One Only, One Day | Biological | Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg) |
| BMS-945429Also: ClazakizumabInjection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day | Biological | Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg), Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg) |
| BMS-945429Also: ClazakizumabInjection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks | Biological | Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg) |
| BMS-945429Also: ClazakizumabInjection, Intravenous (IV), 150 mg, Day One Only, One Day | Biological | Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg) |
| BMS-945429Also: ClazakizumabInjection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks | Biological | Maintenance Cohort: BMS-945429 (Clazakizumab)(100 SC mg) |
| BMS-945429Also: ClazakizumabInjection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks | Biological | Maintenance Cohort: BMS-945429 (Clazakizumab)(200 SC mg) |
| BMS-945429Also: ClazakizumabInjection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period | Biological | Open Label Cohort: BMS-945429 (Clazakizumab)(200 SC mg) |
Primary outcome
Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)
Time frame: At 8 weeks during the Induction Period
CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity
6 secondary outcomes
Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI
Time frame: At 8 weeks during the Induction Period
Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Time frame: Week 8 and Week 12
Number of Participants During the Induction Period With Anti-clazakizumab Antibodies
Time frame: Up to Week 12
Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period
Time frame: Week 4, Week 8
Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period
Time frame: Week 0 and Week 4
Area Under the Plasma Concentration-time Curve in One Dosing Interval [AUC(TAU)] of Clazakizumab During the Induction Period
Time frame: Week 0, Week 4, Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
56 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-945429 in people with Crohn's Disease, run by CSL Behring at 56 sites in 18 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 3 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 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Germany, France, India, Italy and 13 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. 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 Dec 2021). 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?
Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI) (time frame: At 8 weeks during the Induction Period). 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 Dec 2021.