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

Primary Purpose

Crohn's Disease

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Olokizumab (OKZ)

Placebo

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Olokizumab, OKZ, CDP6038, Crohn's Disease, CDAI, IBDQ

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

OKZ 120 mg

OKZ 240 mg

OKZ 120 mg with 480 mg loading dose at Week 0

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

Percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 16

Full Information

NCT ID

NCT01635621

First Posted

July 3, 2012

Last Updated

October 29, 2012

Sponsor

UCB BIOSCIENCES GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01635621

Brief Title

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

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Study was withdrawn due to delay in timelines. There were no safety concerns regarding the study or the compound in the decision to withdraw the trial.

Study Start Date

June 2012 (undefined)

Primary Completion Date

August 2013 (Anticipated)

Study Completion Date

August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UCB BIOSCIENCES GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OKZ 120 mg

Arm Type

Experimental

Arm Title

OKZ 240 mg

Arm Type

Experimental

Arm Title

OKZ 120 mg with 480 mg loading dose at Week 0

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Olokizumab (OKZ)

Other Intervention Name(s)

CDP6038

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

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

Time Frame

Week 16

Title

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

Time Frame

Week 16

Title

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

Time Frame

From Baseline to Week 16

Title

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

Time Frame

From Baseline to Week 16

Title

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

Time Frame

Week 16

Title

Percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 16

Time Frame

Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

UCB Clinical Trial Call Center

Organizational Affiliation

+1 877 822 9493 (UCB)

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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