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

NCT ID: NCT01635621

Last Updated: 2012-10-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-08-31

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.

Conditions

Crohn's Disease

Keywords

Olokizumab; OKZ; CDP6038; Crohn's Disease; CDAI; IBDQ

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OKZ 120 mg

Group Type: EXPERIMENTAL

Olokizumab (OKZ)

Intervention Type: DRUG

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.

OKZ 240 mg

Group Type: EXPERIMENTAL

Olokizumab (OKZ)

Intervention Type: DRUG

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.

OKZ 120 mg with 480 mg loading dose at Week 0

Group Type: EXPERIMENTAL

Olokizumab (OKZ)

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

CDP6038

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB BIOSCIENCES GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Countries

Bulgaria; Czechia; Germany; Hungary; Poland

Other Identifiers

2011-002517-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CD0001

Identifier Type: -

Identifier Source: org_study_id