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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01635621
• Other study ID #: CD0001
• Secondary ID: 2011-002517-11
• Status: Withdrawn
• Phase: Phase 2
• First received: July 3, 2012
• Last updated: October 29, 2012
• Start date: June 2012
• Est. completion date: August 2013

Study information

• Verified date: October 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsBulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Olokizumab (OKZ)
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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB BIOSCIENCES GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with clinical response or remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 8		Week 8	No
Secondary	Percentage of subjects with clinical response as measured by the Crohn's Disease Activity Index (CDAI) at Week 16		Week 16	No
Secondary	Percentage of subjects with clinical remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 16		Week 16	No
Secondary	Change from Baseline in the Crohn's Disease Activity Index (CDAI) to Week 16		From Baseline to Week 16	No
Secondary	Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 16		From Baseline to Week 16	No
Secondary	Percentage of subjects with Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 16		Week 16	No
Secondary	Percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 16		Week 16	No