Crohn's DiseasePhase 2NCT01635621
A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's Disease
A Phase 2 study testing Olokizumab (OKZ) in people with Crohn's Disease, run by UCB BIOSCIENCES GmbH.
Trial summary
The primary purpose of this multi-centre, double blind-study is to evaluate the clinical response of patients with moderate to severe Cohn's Disease (CD) following treatment with different doses and dose regimens of Olokizumab, relative to placebo. 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?
- Olokizumab (OKZ)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Aug 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male or female, 18 to 65 years of age at Screening
- Diagnosis of CD (colonic localization) confirmed (at least 12 weeks prior to Screening) by either radiological or endoscopic evidence and/or histological examination
- Colonoscopy performed prior to first study medication administration (Week 0) with evidence of active CD and presence of ulceration but with no clinical suspicion of dysplasia or malignancy (colonoscopy to be performed after informed consent has been received, and all other Screening assessments have been completed)
- Moderately to severely active CD (CDAI score: 220 to 450, inclusive) at Baseline
- Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/ parenteral /implantable hormonal contraceptives, intrauterine device or barrier and spermicide)
Who cannot join
- Subject has a diagnosis of Ulcerative Colitis or Indeterminant Colitis as determined by the investigator
- Subject has obstructive strictures with clinical evidence of partial or complete obstruction
- Subject has an active fistula (fistula secreting spontaneously or by gentle pressure)
- Subject has a history of diverticulitis or symptomatic diverticulosis
- Subject has any prior exposure to anti-IL-6 agents (eg, Tocilizumab)
- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 24 weeks following the last dose of the study drug
- Subject has a high risk of infection (eg, subjects with leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections, and subjects who are permanently bedridden or wheelchair bound)
- Subject has a concurrent malignancy or a history of malignancy. Subjects who have been successfully treated and who have remained malignancy-free for at least 5 years prior to Screening may be included
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Olokizumab Administered Subcutaneously to Subjects With Moderate to Severe Crohn's Disease
The primary purpose of this multi-centre, double blind-study is to evaluate the clinical response of patients with moderate to severe Cohn's Disease (CD) following treatment with different doses and dose regimens of Olokizumab, relative to placebo.
- Conditions
- Crohn's Disease
- Being tested
- Olokizumab (OKZ), Placebo
- Keywords
- Olokizumab, OKZ, CDP6038, Crohn's Disease, CDAI, IBDQ
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olokizumab (OKZ)Drug
Also called CDP6038
Subjects will receive one of the following treatment regimens as subcutaneous injection solution on Weeks 0, 2, 4, 6, 8, 10, 12 and 14 of the Treatment Period:
- OKZ 120 mg every 2 weeks
- OKZ 240 mg every 2 weeks
- OKZ 120 mg every 2 weeks, with a loading dose of OKZ 480 mg at Week 0
1.6 mL of OKZ drug substance presented in a glass vial with a 1.2 mL extractable volume at a concentration of 100 mg/mL in the formulation buffer, containing 25 mM sodium citrate, 90 mM sodium chloride, 0.02 % (weight/volume) polysorbate 80, pH 6.0.
PlaceboDrug
Subjects will receive Placebo every 2 weeks as a subcutaneous injection solution (0.9% sodium chloride preservative-free for injection) on Weeks 0, 2, 4, 6, 8, 10, 12 and 14 of the Treatment Period.
| Study group | Role | What they receive |
|---|---|---|
| OKZ 120 mg | Experimental | Not described Receives: Drug: Olokizumab (OKZ) |
| OKZ 240 mg | Experimental | Not described Receives: Drug: Olokizumab (OKZ) |
| OKZ 120 mg with 480 mg loading dose at Week 0 | Experimental | Not described Receives: Drug: Olokizumab (OKZ) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with clinical response or remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 8
Measured: Week 8
Secondary outcomes (6)
Percentage of subjects with clinical response as measured by the Crohn's Disease Activity Index (CDAI) at Week 16
Measured: Week 16
Percentage of subjects with clinical remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 16
Measured: Week 16
Change from Baseline in the Crohn's Disease Activity Index (CDAI) to Week 16
Measured: From Baseline to Week 16
Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 16
Measured: From Baseline to Week 16
Percentage of subjects with Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 16
Measured: Week 16
Percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 16
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Why it stopped: Study was withdrawn due to delay in timelines. There were no safety concerns regarding the study or the compound in the decision to withdraw the trial.
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635621
- Sponsor's protocol ID
- CD0001
- Other IDs
- 2011-002517-11
- Status last verified
- Oct 2012
- First submitted
- 3 Jul 2012
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Olokizumab Administered Subcutaneously to Subjects With Moderate to Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT01635621
- Acronym / sponsor ID
- CD0001
- Conditions
- Crohn's Disease
- Keywords
- Olokizumab, OKZ, CDP6038, Crohn's Disease, CDAI, IBDQ
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn due to delay in timelines. There were no safety concerns regarding the study or the compound in the decision to withdraw the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 9 Jul 2012 (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 primary purpose of this multi-centre, double blind-study is to evaluate the clinical response of patients with moderate to severe Cohn's Disease (CD) following treatment with different doses and dose regimens of Olokizumab, relative to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OKZ 120 mg | Experimental | Drug: Olokizumab (OKZ) |
| OKZ 240 mg | Experimental | Drug: Olokizumab (OKZ) |
| OKZ 120 mg with 480 mg loading dose at Week 0 | Experimental | Drug: Olokizumab (OKZ) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is male or female, 18 to 65 years of age at Screening
- Diagnosis of CD (colonic localization) confirmed (at least 12 weeks prior to Screening) by either radiological or endoscopic evidence and/or histological examination
- Colonoscopy performed prior to first study medication administration (Week 0) with evidence of active CD and presence of ulceration but with no clinical suspicion of dysplasia or malignancy (colonoscopy to be performed after informed consent has been received, and all other Screening assessments have been completed)
- Moderately to severely active CD (CDAI score: 220 to 450, inclusive) at Baseline
- Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/ parenteral /implantable hormonal contraceptives, intrauterine device or barrier and spermicide)
Key exclusion criteria (8 listed)
- Subject has a diagnosis of Ulcerative Colitis or Indeterminant Colitis as determined by the investigator
- Subject has obstructive strictures with clinical evidence of partial or complete obstruction
- Subject has an active fistula (fistula secreting spontaneously or by gentle pressure)
- Subject has a history of diverticulitis or symptomatic diverticulosis
- Subject has any prior exposure to anti-IL-6 agents (eg, Tocilizumab)
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 |
|---|---|---|
| Olokizumab (OKZ)Also: CDP6038Subjects will receive one of the following treatment regimens as subcutaneous injection solution on Weeks 0, 2, 4, 6, 8, 10, 12 and 14 of the Treatment Period: * OKZ 120 mg every 2 weeks * OKZ 240 mg every 2 weeks * OKZ 120 mg every 2 weeks, with a loading dose of OKZ 480 mg at Week 0 1.6 mL of OKZ drug substance presented in a glass vial with a 1.2 mL extractable volume at a concentration of 100 mg/mL in the formulation buffer, containing 25 mM sodium citrate, 90 mM sodium chloride, 0.02 % (weight/volume) polysorbate 80, pH 6.0. | Drug | OKZ 120 mg, OKZ 120 mg with 480 mg loading dose at Week 0, OKZ 240 mg |
| PlaceboSubjects will receive Placebo every 2 weeks as a subcutaneous injection solution (0.9% sodium chloride preservative-free for injection) on Weeks 0, 2, 4, 6, 8, 10, 12 and 14 of the Treatment Period. | Drug | Placebo |
Primary outcome
Percentage of subjects with clinical response or remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 8
Time frame: Week 8
6 secondary outcomes
Percentage of subjects with clinical response as measured by the Crohn's Disease Activity Index (CDAI) at Week 16
Time frame: Week 16
Percentage of subjects with clinical remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 16
Time frame: Week 16
Change from Baseline in the Crohn's Disease Activity Index (CDAI) to Week 16
Time frame: From Baseline to Week 16
Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 16
Time frame: From Baseline to Week 16
Percentage of subjects with Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 16
Time frame: Week 16
Percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 16
Time frame: Week 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
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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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olokizumab (OKZ) in people with Crohn's Disease, run by UCB BIOSCIENCES GmbH.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 30 Oct 2012. 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 was withdrawn before enrolling participants, so there are no results.
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 subjects with clinical response or remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 8 (time frame: Week 8). 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 30 Oct 2012.