A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY<br>TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004)<br>FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Phase 2

Completed

• Conditions: Chronic colon inflammation; Ulcerative colitis; 10017969

• Registration Number: NL-OMON45076
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2019-12-04
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

1. Male or female aged 18 and over at the time of signing the informed
consent.
2. Must understand and voluntarily sign an informed consent document
prior to any study related assessments/procedures being conducted.
3. Must be able to adhere to the study visit schedule and other protocol
requirements.
4. Diagnosis of UC with duration of at least 3 months prior to the
Screening Visit
5. TMS * 6 to * 11 (range: 0-12) prior to randomization in the study.
6. Endoscopic subscore * 2 (range: 0-3) on the Mayo score prior to
randomization in the study.
7. Subjects are required to have a colonoscopy if not performed within
12 months of the Screening Visit
8. Subjects must have had a therapeutic failure, been intolerant to, or
have a contraindication to, at least one of the following: oral
aminosalicylates (ie, 5-aminosalicylic acid [5-ASA] compounds or
sulfasalazine [SSZ]), budesonide, systemic corticosteroids, or
immunosuppressants (eg, 6-mercaptopurine [6-MP], azathioprine [AZA],
or methotrexate [MTX]).
9. Subjects receiving oral corticosteroids may continue their use during
the study, provided that the dose (prednisone * 20 mg/day or
equivalent, budesonide * 9 mg/day) has been stable for 3 weeks prior
to the Screening Visit. If oral corticosteroids were recently discontinued,
discontinuation must have been completed at least 3 weeks prior to the
Screening Visit. Corticosteroid doses should remain stable until the
subject is eligible to start corticosteroids tapering, beginning at the
Week 12 Visit.
10. Oral aminosalicylates are permitted during the study, provided that
treatment started at least 6 weeks prior to randomization with a stable
dose of at least 14 days prior to the Screening Visit. The dose of oral
aminosalicylates must remain stable through Week 52 or until Week 104 for subjects who participate in the Extension Phase.
11. Must meet the following laboratory criteria:
- White blood cell count * 3000/mm3 (* 3.0 X 10E9/L) and <
14,000/mm3 (< 14 X 10E9/L)
- Platelet count * 100,000/mm3 (* 100 X 10E9/L)
- Serum creatinine * 1.5 mg/dL (* 132.6 *mol/L)
- AST (SGOT) and ALT (SGPT) *2 X upper limit of normal (ULN). If initial
test shows ALT or AST > 2 times the ULN, one repeat test is allowed
during the screening period
- Total bilirubin * 2 mg/dL (* 34 *mol/L) or albumin > lower limit of
normal (LLN). If initial test result is > 2 g/dL, one repeat test is allowed
during the screening period
- Hemoglobin * 9 g/dL (* 5.6 mmol/L)
12. 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 taking the last dose of IP, FCBP who engage in
activity in which conception is possible must use one of the approved
contraceptive options2 described below:
Option 1: Any one of the following highly effective methods: hormonal
contraception (oral, injection, implant, transdermal patch, vaginal ring);
intrauterine device (IUD); tubal ligation; or partner's vasectomy
OR
Option 2: Male or female condom (latex condom or nonlatex condom
NOT made out of natural [animal] membrane [for example,
polyurethane]; PLUS one additional barrier method: (a) diaphragm with
spermicide; (b) cervical cap with spermicide; or (c) contraceptive
sponge with sp

Exclusion Criteria

1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis,
microscopic colitis, radiation colitis or diverticular disease-associated
colitis.
2. Ulcerative colitis restricted to the distal 15 cm or less (eg, ulcerative
proctitis).
3. Subjects who have had surgery as a treatment for UC or who, in the
opinion of the Investigator, are likely to require surgery for UC during
the study.
4. Clinical signs suggestive of fulminant colitis or toxic megacolon.
5. Evidence of pathogenic enteric infection.
6. History of colorectal cancer or colorectal dysplasia (with the exception of adenomatous colonic polyps that have been completely resected).
7. Prior use of any TNF inhibitor (or any biologic agent).
8. Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine or
thalidomide.
9. Use of IV corticosteroids within 2 weeks of the Screening Visit
10. Use of immunosuppressants (AZA, 6-MP or MTX) within 8 weeks of
the Screening Visit.
11. Use of topical treatment with 5-ASA or corticosteroid enemas or
suppositories within 2
weeks of the Screening Visit
12. History of any clinically significant neurological, renal, hepatic,
gastrointestinal,
pulmonary, metabolic, cardiovascular, psychiatric, endocrine,
hematological disorder or
disease, or any other medical condition that, in the investigator's
opinion, would preclude
participation in the study.
13. Prior history of suicide attempt at any time in the subject's lifetime
prior to
randomization in the study or major psychiatric illness requiring
hospitalization within 3
years of study randomization.
14. Any condition, including the presence of laboratory abnormalities,
which places the
subject at unacceptable risk if he/she was to participate in the study or
confounds the
ability to interpret data from the study.
15. Pregnant or breast feeding.
16. History of any of the following cardiac conditions within 6 months of
screening:
myocardial infarction, acute coronary syndrome, unstable angina, new
onset atrial
fibrillation, new onset atrial flutter, second- or third-degree
atrioventricular block,
ventricular fibrillation, ventricular tachycardia, heart failure, cardiac
surgery,
interventional cardiac catheterization (with or without a stent
placement), interventional
electrophysiology procedure, or presence of implanted defibrillator.
17. Known active current or history of recurrent bacterial, viral, fungal,
mycobacterial or
other infections (including but not limited to tuberculosis and atypical
mycobacterial
disease and herpes zoster), human immunodeficiency virus (HIV), or any
major episode
of infection requiring hospitalization or treatment with intravenous (IV)
or oral
antibiotics within 4 weeks of screening.
18. Subjects with active hepatitis B infection as described in Appendix E
are ineligible for
the study. Subjects without current hepatitis B infection, as described in
Appendix F, may
participate in the study.
19. Subjects who are confirmed positive for hepatitis C antibody not eligible
for the study.
20. History of congenital or acquired immunodeficiency (eg, Common
Variable Immunodeficiency Disease).
21. History of malignancy, except for:
a. Treated (ie, cured) basal cell or squamous cell in situ skin

Study & Design

• Study Type: Interventional
• Study Design: Not specified