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

NCT01635621 | Withdrawn Phase 2

• 2 other identifiers: CD00012011-002517-11
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with clinical response or remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 8

  Week 8

Secondary Outcomes (6)

• Percentage of subjects with clinical response as measured by the Crohn's Disease Activity Index (CDAI) at Week 16

  Week 16

• Percentage of subjects with clinical remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 16

  Week 16

• Change from Baseline in the Crohn's Disease Activity Index (CDAI) to Week 16

  From Baseline to Week 16

• Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 16

  From Baseline to Week 16

• Percentage of subjects with Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 16

  Week 16

Study Arms (4)

OKZ 120 mg

EXPERIMENTAL

Drug: Olokizumab (OKZ)

OKZ 240 mg

EXPERIMENTAL

Drug: Olokizumab (OKZ)

OKZ 120 mg with 480 mg loading dose at Week 0

EXPERIMENTAL

Drug: Olokizumab (OKZ)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Olokizumab (OKZ) 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.

Also known as: CDP6038

OKZ 120 mg; OKZ 120 mg with 480 mg loading dose at Week 0; OKZ 240 mg

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB BIOSCIENCES GmbH: lead

MeSH Terms

Conditions

Crohn Disease

Interventions

olokizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 9, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 30, 2012

Record last verified: 2012-10