A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's Disease

UCB

Status and phase: Withdrawn; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Olokizumab (OKZ); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01635621

CD0001

2011-002517-11 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

OKZ 120 mg

Experimental group

Treatment:

Drug: Olokizumab (OKZ)

OKZ 240 mg

Experimental group

Treatment:

Drug: Olokizumab (OKZ)

OKZ 120 mg with 480 mg loading dose at Week 0

Experimental group

Treatment:

Drug: Olokizumab (OKZ)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo