EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS

Phase 1

Conditions: lcerative Colitis
MedDRA version: 19.1Level: LLTClassification code 10021184Term: IBDSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2016-001684-36-ES

Lead Sponsor: PPM SERVICES SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 207

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study:
1. Male or female aged 18 and over at the time of signing the informed consent.
2. Must understand and voluntarily sign an ICF 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 a duration of at least 3 months prior to the Screening Visit.
5. MMS = 4 to = 8 (range: 0 - 9) prior to randomization in the study
• SFS = 1 and RBS = 1 or 2
• Mayo endoscopic sub-score > 1 and < 3 prior to randomization in the study
6. Subjects are required to have a colonoscopy if one has not been performed within 12 months prior to the Screening Visit.
7. Subjects who have relapsed on maintenance therapy with doses of 5-ASA = 2.4 g/day.
8. Must meet the following laboratory criteria:
• WBC count = 3000/mm3 and < 14,000/mm3
• Platelet count = 100,000/mm3
• Serum creatinine = 1.5 mg/dL (= 132.6 µmol/L)
• AST (SGOT) and ALT (SGPT) = 2 upper limit of normal (ULN). If initial test shows ALT or AST > 2 ULN, 1 repeat test is allowed during the screening period
• Total bilirubin = 2 mg/dL (= 34 mol/L) and albumin > lower limit of normal (LLN). If initial albumin test result is < 2 g/dL, 1 repeat test is allowed during the screening period
• Hemoglobin = 9 g/dL (= 5.6 mmol/L)
9. 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 options
10. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception while on investigational product and for at least 28 days after the last dose of investigational product.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 196
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

The presence of any of the following will exclude a subject from enrollment:
1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis.
2. UC 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.
7. Prior use of any TNF inhibitor (or any biologic agent).
8. Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide.
9. Subjects who have relapsed on maintenance therapy with doses of 5-ASA > 2.4 g/day will be excluded from the study. If a subject had a recent 5-ASA dose reduction from > 2.4g/day to = 2.4 g/day and relapsed within 2 weeks of that dose reduction.
10. Oral aminosalicylates are not permitted during the study.
11. Use of budesonide-MMx within the last 8 weeks.
12. Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit.
13. Use of immunosuppressants (azathioprene [AZA], 6-mercaptopurine [6-MP] or methotrexate [MTX]) within 8 weeks of the Screening Visit.
14. Use of topical treatment with 5-ASA or corticosteroid enemas or suppositories within 2 weeks of the Screening Visit.
15. History of any clinically significant neurological, renal, hepatic, GI, 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.
16. 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.
17. 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.
18. Pregnant or breast feeding.
19. 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.
20. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis, atypical mycobacterial disease, and herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with IV or oral antibiotics within 4 weeks of screening.
21. Subjects with active hepatitis B infection, as described in Appendix D of the protocol, are ineligible for the study. Subjects without current hepatitis B infection, as described in Appendix E of the protocol, may participate in the study.
22. Subjects who are positive for the hepatitis C antibody are not eligible for the study.
23. History of congenital or acquired immunodeficiency (eg, Common Variable

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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