A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02367183
• Date of registration: 13/02/2015
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease
• Scientific title: A Randomized, Double-blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects With Active Crohn's Disease.
• Date of first enrolment: April 8, 2015
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02367183
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Australia, Canada, Hungary, Slovakia, United States

Contacts

• Name: Guillermo Rossiter, MD
• Affiliation: Celgene

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Is a male or female who is =18 years at the time of signing the Informed Consent Form
(ICF).

2. Understand and voluntarily sign an Informed Consent Form (ICF) prior to conducting any
study related assessments/procedures.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Diagnosis of Crohn's Disease (CD) with a duration of at least 3 months prior to
screening.

5. Diagnosis of ileitis, ileocolitis or colitis , as determined by endoscopic,
radiographic or any other imaging modality (eg, magnetic resonance imaging [MRI],
computed tomography [CT] scan) evaluation performed within 2 years prior to screening.
Subjects with colitis restricted to the left colon will not be allowed in the trial.

6. Active disease, defined as Crohn's Disease Activity Index (CDAI) score = 220 and = 450
(range: 0 to 600) at screening.

7. Simple Endoscopic Score for Crohn's Disease (SES-CD) score = 7 at screening. Subjects
with ileitis only will require Simple Endoscopic Score for Crohn's Disease (SES-CD) =
4

8. Must have failed or experienced intolerance to at least one of the following:

aminosalicylates, budesonide, systemic corticosteroids, immunosuppressants (ie, 6
mercaptopurine [6-MP], azathioprine [AZA], or methotraxate [MTX]) or tumor necrosis
factor-a tumor necrosis factor-a (TNF-a) blockers (eg, infliximab, adalimumab or
certolizumab) .

9. Subjects receiving oral aminosalicylates may continue their use during the study,
provided that dose has been stable for at least 2 weeks prior to screening. The dose
of oral aminosalicylates must remain stable through the duration of the study or early
termination from the study. If oral aminosalicylates have been recently discontinued,
treatment must have been stopped at least 2 weeks prior to screening.

10. Subjects receiving oral corticosteroids may continue their use during the Induction
Phase, provided that the dose (prednisone = 20 mg/day or equivalent, budesonide = 9
mg/day) has been stable for 3 weeks prior to screening. If oral corticosteroids were
recently discontinued, discontinuation must have been completed at least 4 weeks prior
to screening. Corticosteroid doses should remain stable until the subject is eligible
to start corticosteroids tapering.

11. Subjects receiving immunosuppressants, such as , 6 mercaptopurine (6-MP), azathioprine
(AZA), or methotraxate (MTX) may continue their use during the study, provided that
treatment was initiated = 12 weeks prior to screening. The dose of immunosuppressants
must be at a stable dose for = 8 weeks prior to the Baseline Visit and must remain
stable through the duration of the study or early termination from the study. Subjects
who discontinued immunosuppressants should have stopped them at least 8 weeks prior to
screening.

12. Must meet the following laboratory criteria:

1. White blood cell count = 3000/mm3 (= 3.0 X 10^9//L) and < 14,000/mm3 (< 14.0 X
10^9/L)

2. Platelet count = 100,000/mm3 (= 100 X 10^9/L)

3. Serum creatinine = 1.5 mg/dL (= 132.6 µmol/L)

4. Aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT)
and alanine aminotransferase (ALT) / serum glutamic-pyruvic transaminase (SGPT) =
2 X upper limit of normal (ULN)

5. Total bilirubin = 2 mg/dL (= 34 µmol/L) unless there is a confirmed diagnosis of
Gilbert's disease

6. Hemoglobin = 9 g/dL (= 5.6 mmol/L)

7. Activated partial thromboplastin time (APTT) = 1.5 X ULN

13. Females of childbearing potential (FCBP) must have a negative pregnancy test at
Screening and the Baseline Visit. While on IP and for at least 28 days after the Early
Termination Visit or the end-of-study visit (Observation Week 52 or Extension Week
24), FCBP who engage in activity in which conception is possible must use 1 of the
approved contraceptive options2 described below: Option 1: Any one of the following
highly effective methods: hormonal contraception (for example, birth control pills,
injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal
ligation (tying your tubes); or a partner with a vasectomy OR

Option 2: Any two of the following effective methods: male or female condom PLUS one
of the following additional barrier methods:

1. diaphragm with spermicide;

2. cervical cap with spermicide; or

3. contraceptive sponge with spermicide

14. Male subjects (including those who have had a vasectomy) who engage in activity in
which conception is possible must use barrier contraception (male latex condom or
nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane])
while on Investigational Product (IP) and for at least 28 days after the Early
Termination Visit or the end-of-study visit (Observation Week 52 or Extension Week
24).

Exclusion Criteria:

1. Diagnosis of Crohn's colitis restricted to the left colon , ulcerative colitis (UC),
indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or
diverticular disease-associated colitis.

2. Local manifestations of Crohn's Disease (CD) such as strictures, abscesses, fistula,
short bowel syndrome or other disease complications for which surgery might be
indicated or could confound the evaluation of efficacy.

3. Intestinal resection within 6 months or any intra-abdominal surgery within 3 months
prior to screening.

4. Subjects with an ileostomy or a colostomy.

5. Stool positive for any enteric pathogen or C. difficile toxin at screening.

6. History of colorectal cancer or colorectal dysplasia.

7. Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide or
apheresis (eg, Adacolumn) for the treatment of CD. In addition, prior use of any of
these treatment modalities for an indication other than CD within 8 weeks of screening
is also excluded.

8. Use of intravenous (IV) corticosteroids within 2 weeks of screening.

9. Use of topical treatment with 5 aminosalicylic acid (5-ASA) or corticosteroid enemas
or suppositories within 2 weeks of screening

10. Use of antibiotic therapy for the treatment of Crohn's Disease (CD) within 3 weeks of
screening.

11. Use of cholestyramine within 3 weeks of screening.

12. Prior treatment with more than 2 tumor necrosis factor-a (TNF-a) blockers.

13. Prior treatment with any integr


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Placebo

Drug: GED-0301

Primary Outcome(s)

Change in SES-CD Score [Time Frame: Week 12]

Secondary Outcome(s)

Proportion of subjects achieving a clinical remission, defined as a CDAI score < 150 at Induction Week 4 [Time Frame: Week 4]

Adverse Event (AE) [Time Frame: Up to 97 weeks]

Secondary ID(s)

GED-0301-CD-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors