- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01635621
A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's Disease
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
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.
|
Experimental: OKZ 120 mg
|
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:
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.
Other Names:
|
Experimental: OKZ 240 mg
|
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:
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.
Other Names:
|
Experimental: OKZ 120 mg with 480 mg loading dose at Week 0
|
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:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of subjects with clinical response as measured by the Crohn's Disease Activity Index (CDAI) at Week 16
Time Frame: Week 16
|
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
|
Week 16
|
Change from Baseline in the Crohn's Disease Activity Index (CDAI) to Week 16
Time Frame: From Baseline to Week 16
|
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
|
From Baseline to Week 16
|
Percentage of subjects with Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 16
Time Frame: Week 16
|
Week 16
|
Percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 16
Time Frame: Week 16
|
Week 16
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD0001
- 2011-002517-11 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Massachusetts General HospitalAmerican College of GastroenterologyNot yet recruitingInflammatory Bowel Diseases | Crohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's EsophagitisUnited States
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