An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease

Phase 1

• Conditions: Crohn's Disease; MedDRA version: 19.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-001249-10-HU
• Lead Sponsor: Gilead Sciences, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-10
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this
study.
1) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
2) Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
3) Females of childbearing potential must have a negative pregnancy test at screening and baseline.
4) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol
5) Documented diagnosis of Crohn’s disease with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum
6) Moderately to severely active Crohn’s disease as defined by a CDAI total score between
220-450 (inclusive) AND with protocol defined parameters
7) Within the previous 5 years, demonstrated an inadequate clinical response, loss of response to, or intolerance of at least one of the following agents as defined in the protocol:
a) Corticosteroids
b) Immunomodulators
c) TNFa Antagonists
d) Vedolizumab
8) Protocol defined Laboratory parameters
9) May be receiving the following drugs:
a) Oral 5-aminosalicylate (5-ASA) compounds provided the dose has been stable for at least 2 weeks prior to screening
b) Oral corticosteroid therapy (prednisone at a stable dose = 30 mg/day or budesonide at a
dose of = 9 mg/day) provided the dose has been stable for 2 weeks prior to screening
c) Antidiarrheals for chronic diarrhea
d) Azathioprine or 6-MP or methotrexate provided the dose has been stable for 4 weeks
prior to screening
e) Antibiotics for the treatment of Crohn’s Disease (e.g., metronidazole, ciprofloxicin)
provided the dose has been stable for the 2 weeks prior to screening or is consistent with
subject’s standard low-dose regimen
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 155
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1) Pregnant or lactating females
2) Males and females of reproductive potential who are unwilling to use an effective
contraception during the study or complete abstinence from intercourse from the date of
screening to study completion and up to 90 days post last dose of the study drug
3) Females who may wish to become pregnant and/or plan to undergo egg donation or egg
harvesting for the purpose of current or future fertilization during the course of the study and
up to 30 days of the last dose of the study drug
4) Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose
of study drug
5) Known hypersensitivity to GS-5745
6) Evidence of abscess at screening
7) Extensive colonic resection (subtotal or total colectomy) or history of > 2 small bowel resections
8) Ileostomy, colostomy, or symptomatic stenosis of the intestine
9) Current use of oral corticosteroids at a dose equivalent to > 30 mg/day of prednisone
10) Ulcerative colitis or indeterminate colitis
11) Short bowel syndrome
12) Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella,
Shigella, Campylobacter or Yersinia
13) Treatment with infliximab, adalimumab, natalizumab, golimumab, vedolizumab,
certolizumab, or any other monoclonal antibody within 4 weeks of screening.
14) Clinically significant active infection
15) History or evidence of colonic mucosal dysplasia
16) Chronic medical or psychiatric problem that may interfere with subject’s ability to comply with study procedures
17) Co-infection with chronic HIV, hepatitis B, or hepatitis C
18) Active tuberculosis (TB) infection or history of latent tuberculosis that has not been treated
19) Alcohol or drug abuse (in the opinion of the Investigator) that would interfere with
compliance
20) History of malignancy within the last 5 years except for subjects who have been treated or resected for non-melanoma skin cancer or cervical carcinoma in situ
21) Any other investigational therapy or investigational biologics use within 4 weeks of
screening
22) Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol

Study & Design

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