Clinical trial NCT01635621: A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Olokizumab
OKZ
CDP6038
Crohn's Disease
CDAI
IBDQ
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of subjects with clinical response or remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of subjects with clinical response as measured by the Crohn's Disease Activity Index (CDAI) at Week 16
timeFrame: Week 16
measure: Percentage of subjects with clinical remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 16
timeFrame: Week 16
measure: Change from Baseline in the Crohn's Disease Activity Index (CDAI) to Week 16
timeFrame: From Baseline to Week 16
measure: Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 16
timeFrame: From Baseline to Week 16
measure: Percentage of subjects with Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 16
timeFrame: Week 16
measure: Percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: