A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Phase 1

• Conditions: Moderately to severely active Ulcerative Colitis; MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-003123-38-BE
• Lead Sponsor: Celgene International II Sàrl (CIS II)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 86

Inclusion Criteria

1. Males or female patients aged 18 to 75 years, inclusive
2. Have had UC diagnosed at least 2 months prior to screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence
3. Have active UC confirmed on endoscopy with = 15 cm involvement
4. Have active UC defined as Mayo score of 6-12 inclusive with endoscopic subscore of = 2
5. Have undergone colonoscopy or sigmoidoscopy within the past 2 years for extent of disease, and if the UC has been present for > 10 years, have had a colonoscopy with biopsy to rule out dysplasia
6. Female patients of childbearing potential:
Must agree to practice a highly effective method of contraception of the 75-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in
combination result in a failure rate of a Pearl index of less than 1% per
year when used consistently and correctly. Acceptable methods of birth
control in the trial are the following:
- Combined hormonal (oestrogen and progestogen containing)
contraception, which may be oral, intravaginal, or transdermal
- Progestogen-only hormonal contraception associated with inhibition of
ovulation, which may be oral, injectable, or implantable
- Placement of an intrauterine device (IUD)
- Placement of an intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomised partner
- Sexual abstinence
Male patients:
Must agree to use a latex condom during sexual contact with women of
childbearing potential while participating in the study until completion of
the 75-day Safety Follow-up Visit.
All patients:
Periodic abstinence (calendar, symptothermal, post-ovulation methods),
withdrawal (coitus interruptus), spermicides only, and lactational
amenorrhoea method are not acceptable methods of contraception.
Female condom and male condom should not be used
7. Must be currently receiving treatment with at least 1 of the following therapies:
a. Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide) for at least 6 weeks with the dose stable for at least 3 weeks prior to screening endoscopy
b. Prednisone (doses = 30 mg) or equivalent for at least 4 weeks and receiving a stable dose for at least 2 weeks
8. If oral aminosalicylates or corticosteroids have been recently discontinued, they must have been stopped for at least 2 weeks prior to the endoscopy used for baseline Mayo Score
9. All patients aged 45 years or over must have had a colonoscopy to screen for adenomatous polyps within 5 years of their first dose of investigational drug or must have had a colonoscopy at screening to assess for polyps. The adenomatous polyps must be removed prior to their first dose of investigational drug.
10. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
11. Patients must have documentation of positive Varicella Zoster virus (VZV) IgG

Exclusion Criteria

1. Have severe extensive colitis evidenced by:
- Physician judgment that patient is likely to require colectomy or
ileostomy within 12 weeks of baseline
- Current evidence of fulminant colitis,toxic megacolon or bowel
perforation
- Previous total colectomy
- Have 4 or more of the following:
Temp > 38°C, Heart rate (HR) > 110 (bpm);Focal severe or rebound
abdominal tenderness;Anemia (hemoglobin [Hgb] < 8.5 g/dL);
Transverse colon diameter > 5cm on plain X-ray
2. Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
3. Have positive stool culture for pathogens (O+P, bacteria) or positive test for C. difficile at screening. If C. difficile is positive, the patient may be treated and retested
4. Have had treatment with cyclosporine, tacrolimus, sirolimus, or
mycophenolate mofetil (MMF) within 16 weeks of screening
5. Pregnancy, lactation, or a positive serum beta human chorionic
gonadotrophin (hCG) measured during screening
6. Clinically relevant hepatic, neurological, pulmonary,ophthalmological,endocrine, psychiatric or other major systemic disease making implementation or interpretation of the study difficult or that would put the patient at risk
7. Clinically relevant cardiovascular conditions, including history or
presence of:
i. Recent (within the last 6 months) occurrence of myocardial infarction,
unstable angina, stroke, transient ischemic attack, decompensated heart
failure requiring hospitalization, Class III/IV heart failure, sick sinus
syndrome, or severe untreated sleep apnea
ii. Prolonged QTcF interval (QTcF > 450 msec males, > 470 msec
females), or at additional risk for QT prolongation (e.g., hypokalemia,
hypomagnesemia, congenital long-QT syndrome, concurrent therapy
with QT prolonging drugs)
iii. Patients with other pre-existing stable cardiac conditions who have
not been cleared for the study by an appropriate cardiac evaluation by a
cardiologist
8. Resting HR less than 55 beats per minute (bpm)
9. History of diabetes mellitus type 1, or uncontrolled diabetes mellitus
type 2 with hemoglobin A1c > 7%, or diabetic patients with significant
co-morbid conditions such as retinopathy or nephropathy
10. History of uveitis
11. Known active bacterial, viral, fungal, mycobacterial infection or other infection (including TB or atypical mycobacterial disease [excluding fungal infection of nail beds]) or any major episode of infection that required hospitalization/treatment with intravenous (IV) antibiotics within 30 days or oral antibiotics within 14 days prior to screening
12. History of recurrent or chronic infection (e.g., hepatitis B or C,
human immunodeficiency virus, syphilis, TB); recurring urinary tract
infections are allowed
13. History of cancer, including solid tumors and hematological

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified