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Trial record 1 of 1 for:    NCT01635621
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A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01635621
Recruitment Status : Withdrawn (Study was withdrawn due to delay in timelines.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.)
First Posted : July 9, 2012
Last Update Posted : October 30, 2012
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Olokizumab (OKZ) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: OKZ 120 mg 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.

Other Name: CDP6038

Experimental: OKZ 240 mg 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.

Other Name: CDP6038

Experimental: OKZ 120 mg with 480 mg loading dose at Week 0 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.

Other Name: CDP6038

Placebo Comparator: Placebo 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.




Primary Outcome Measures :
  1. 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 Measures :
  1. Percentage of subjects with clinical response as measured by the Crohn's Disease Activity Index (CDAI) at Week 16 [ Time Frame: Week 16 ]
  2. Percentage of subjects with clinical remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 16 [ Time Frame: Week 16 ]
  3. Change from Baseline in the Crohn's Disease Activity Index (CDAI) to Week 16 [ Time Frame: From Baseline to Week 16 ]
  4. Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 16 [ Time Frame: From Baseline to Week 16 ]
  5. Percentage of subjects with Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 16 [ Time Frame: Week 16 ]
  6. Percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 16 [ Time Frame: Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635621


Sponsors and Collaborators
UCB BIOSCIENCES GmbH
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

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Responsible Party: UCB BIOSCIENCES GmbH
ClinicalTrials.gov Identifier: NCT01635621    
Other Study ID Numbers: CD0001
2011-002517-11 ( EudraCT Number )
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012
Keywords provided by UCB Pharma ( UCB BIOSCIENCES GmbH ):
Olokizumab
OKZ
CDP6038
Crohn's Disease
CDAI
IBDQ
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases